Osteoarthritis, KneeHColl_HTONCT03601130
Assessment of HydroxyColl Bone Graft Substitute in High Tibial Osteotomy Wedge Grafting.
A study testing HydroxyColl Bone Graft Substitute in people with Osteoarthritis, Knee, run by SurgaColl Technologies Limited at 1 site in United Kingdom.
Trial summary
The overall goal of this study is to demonstrate the safety and efficacy of Hydroxycoll bone graft substitute when used in the treatment of patients undergoing surgical treatment for varus mis-alignment in medial unicompartmental osteoarthritis of the knee. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- HydroxyColl Bone Graft Substitute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2018to 29 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to give written informed consent to participate in this study
- Both male and females who will be admitted to the hospital for treatment of varus mis-alignment in medial unicompartmental osteoarthritis of the knee of the degree to which the surgeon deems it necessary to include a bone grafting procedure
- Kellgren-Lawrence grade 1-4
- Ability and willingness to comply with all study requirements
Who cannot join
- History or presence of the following conditions: known sensitivity to bovine collagen or hydroxyapatite materials; diabetes, immune-compromised, vascular disease, metabolic/systemic bone disorder, osteomyelitis
- Failure to provide written informed consent
- Severe acute or chronic medical illness, including symptomatic cardiovascular disease
- Weight less than 40 kilograms
- Any clinically significant abnormality at the time of submission, in the judgement of the investigator would preclude safe completion of the study
- Any use of estrogens, estrogen-progestin therapy, selective estrogens receptor modulators (SERMs) or calcitonin within 3 months, and use of bisphosphonates or recombinant PTH 1-34, 1-84 or other PTH fragments/analogues within the last 6 months
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- History of alcohol or drug abuse within the last year
- History of non-compliance to medical regimens and/or patients who are considered potentially unreliable
- Significant psychiatric disorder or behaviour
- Presence of any concomitant condition which, in the opinion of the investigator or the sponsor, may interfere with the interpretation of efficacy and safety data gathered in this study including chronic infections
- Chronic or >7 days concomitant use of oral corticosteroids within 1 month prior to screening
- Regular smoker (more than 10 cigarettes per day) for the last 12 months
- Participation in another interventional orthopaedic clinical trial within 1 month of the beginning of this study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Basingstoke & North Hampshire Hospital
Basingstoke
Angie Dempster, 00447867141077, Angie.Dempster@hhft.nhs.uk
Paula Chatterton, 00441256 313204, Paula.Chatterton@hhft.nhs.uk
About this study
Official title: Post Market Clinical Follow up - Assessment of HydroxyColl Bone Graft Substitute in High Tibial Osteotomy Wedge Grafting.
The overall goal of this study is to demonstrate the safety and efficacy of Hydroxycoll bone graft substitute when used in the treatment of patients undergoing surgical treatment for varus mis-alignment in medial unicompartmental osteoarthritis of the knee. HydroxyColl bone graft substitute will be evaluated when utilized in Open Wedge High Tibial Osteotomy with medial plate fixation. Its safety profile will be evaluated as defined by the number of reported adverse events.
Read the detailed description
Osteoarthritis (OA) of the knee is joint damage, resulting in pain accompanied by varying degrees of functional limitation and reduced quality of life. 20% of adults over 50 and 40% over 80 years report disability from knee pain secondary to osteoarthritis.The majority of patients present to primary care with symptoms of pain and stiffness, which reduces mobility and with associated reduction in quality of life, with many patients not requiring surgery, with their symptoms adequately controlled by non-surgical measures. When patient's symptoms are not controlled by up to 3 months of non-operative treatment they become candidates for assessment for joint surgery. There are a number of surgical (Arthroscopy, Total/Partial Knee Replacement, High Tibial Osteotomy) and non-surgical (including exercise, weight loss, manual therapy, oral medication, injection therapy, splints and braces) options available. The decision to undergo surgery is based on patient symptom pattern, with the type of surgery determined by the pattern of joint damage and the patient's preference. High Tibial Osteotomy (HTO) should be considered primarily for patients with varus mis-alignment in medial unicompartmental osteoarthritis of the knee as the main indication for the procedure. HTO involves removing or adding bone to realign the limb and offload the knee. It is effective and can provide functional outcomes similar to those seen after joint replacement. HTO is a commonly used surgical procedure and has wide appeal because of the preservation of the knee joint. The principal advantages of opening wedge high tibial osteotomy include maintenance of the bone stock, correction of the deformity close to its origin, and no requirement for a fibular osteotomy. Although it is a good option for young patients with isolated medial compartment OA and varus deformity, it can be done even for older active people over 65. By preserving the patient's own knee anatomy, a successful osteotomy may delay the need for a joint replacement for several years. Another advantage is that there are no restrictions on physical activities after an osteotomy, even high impact exercise.
Contemporary Surgical approaches to HTO can often utilise bone graft substitutes to improve patient outcomes. Bone grafting in open wedge high tibial osteotomy (HTO) is an area of clinical research that requires further evaluation. While open wedge high tibial osteotomy (OWHTO) with medial plate fixation is a proven adequate and safe method for treatment of medial compartment osteoarthritis of the knee and varus deformity, particularly in young and/or active, it nevertheless creates a gap in the metaphysis of the tibia. To enhance bone healing and increase initial mechanical stability, a high degree HTO may require the application of bone graft/substitute to fill the osteotomy gap. Moreover, HTO has been associated with risk of nonunion, collapse and loss of correction. Autologous bone graft is the "gold standard" to fill the bone defect, but iliac crest graft harvest has risks. The associated complications include pain, thigh hypoesthesia, infection, pelvic bone fracture and discomfort wearing clothes. Allograft is commonly used to avoid the risks of autografting, such as donor side morbidity. However, the use of allograft increases additional risks such as disease transmission, immunologic reactions and slow remodelling. Due to the limited autologous bone availability and the problem of donor-site morbidity, many efforts have been made to find adequate supporting material for augmentation after osteotomy. Hydroxyapatite, β-tricalcium phosphate or the combination of both are the most commonly used synthetic augments in HTO. However, the most suitable material for filling the opening space in OWHTO has not been conclusively identified. While HTO with and without bone grafting has been assessed as radiologically equivalent, of particular interest to clinicians and patients is the contention around the secondary outcomes (site morbidity and bleeding, chronic pain, patient discomfort long term) which are frequently a challenge in postoperative management of patients. Autologous bone graft would still be the best choice for a lot of applications where bone grafting is needed but there are many disadvantages - the relatively high donor morbidity and the limited amount which can be harvested - which will eventually lead to a very restricted use of it. Allografts do not have these limitations, but in the form of demineralized bone matrix they have very variable osteoinductive properties and can possibly transmit diseases. Synthetic 2nd generation biomaterials have a long and safe history of use but do not provide a compelling alternative to traditional bone grafting. 3rd generation biomaterials as bone graft substitutes, such as HydroxyColl, offer exciting prospects of improved patient clinical outcomes and may provide a viable alternative to autologous bone grafts. Treatment for these patients would be with Open Wedge High Tibial Osteotomy with medial plate fixation. Over the period of the trial, adverse events will be reported by the study centre and it will be the prominence or absence of these, along with blood inflammatory marker evaluations that will determine the inherent safety of Hydroxycoll compared to the standard of care. At each follow up visit x-rays will be performed and evaluated by a certified radiologist. Site morbidity and bleeding will be clinically assessed. They will report and assess the radiographic images determining if healing has occurred. Along with the clinical assessment, the surgeon or a member of the clinical team will determine extent of healing. Patients will also self-report a number of key pain, mobility and post-operative joint inflammation outcomes.
The study is a single centre randomized blinded study to assess the efficacy and safety of Hydroxycoll bone graft substitute used as a bone graft substitute in Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care). This study has been designed to last for 52 weeks with follow up visits post surgery, 6 weeks, 12 weeks and a final follow-up at 52 weeks. In case of AEs/SAEs ongoing when the patient has completed the study, the patient will be contacted by phone one month after study completion for follow-up. The study will have 2 arms with 20 subjects per arm, each receiving at the time of surgical intervention either; 1) Open Wedge High Tibial Osteotomy with medial plate fixation (without bone grafting). 2) Open Wedge High Tibial Osteotomy with medial plate fixation (with bone grafting) using Hydroxycoll bone graft substitute. An Independent Review Board (IRB) will approve the protocol before the study begins. A clinical monitor selected by SurgaColl will monitor the trial. Any serious adverse events (SAE) will be reported as soon as possible (within 48 hours of awareness) to SurgaColl by the study centre. SurgaColl will communicate the SAE to all relevant authorities.
- Conditions
- Osteoarthritis, Knee
- Being tested
- HydroxyColl Bone Graft Substitute, DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)
- Keywords
- osteotomy, osteoarthritis, bone graft substitute
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxyColl Bone Graft SubstituteDevice
The intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) with the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute.
DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)Device
The intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) without the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute.
| Study group | Role | What they receive |
|---|---|---|
| No Bone Graft | Other | Open Wedge High Tibial Osteotomy with medial plate fixation (without bone grafting) Receives: Device: DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) |
| HydroxyColl Bone Graft Substitute | Active comparator | Open Wedge High Tibial Osteotomy with medial plate fixation (with bone grafting) using Hydroxycoll bone graft substitute. Receives: Device: HydroxyColl Bone Graft Substitute; Device: DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Healing
clinical assessment of healing based on radiological observations by a member of the clinical team
Measured: Week 6
Radiological Healing
clinical assessment of healing based on radiological observations by a member of the clinical team
Measured: Week 12
Radiological Healing
clinical assessment of healing based on radiological observations by a member of the clinical team
Measured: Week 52
Knee injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Day 0
Knee injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Day 1
Knee injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Week 6
Knee injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Week 12
Knee injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Week 52
EQ5D Score
Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Day 0
EQ5D Score
Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Day 1
EQ5D Score
Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Week 6
EQ5D Score
Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Week 12
EQ5D Score
Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Week 52
VAS Score
Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].
Measured: Day 0
VAS Score
Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].
Measured: Day 1
VAS Score
Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].
Measured: Week 6
VAS Score
Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].
Measured: Week 12
VAS Score
Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].
Measured: Week 52
Secondary outcomes (5)
Safety outcome based on clinical assessment of the adverse events reported during the trial.
Safety outcome based on clinical assessment of the adverse events reported during the trial specifically related to the Hydroxycoll and compared to standard of care.
Measured: Day 0
Safety outcome based on clinical assessment of the adverse events reported during the trial
Safety outcome based on clinical assessment of the adverse events reported during the trial specifically related to the Hydroxycoll and compared to standard of care.
Measured: Day 1
Safety outcome based on clinical assessment of the adverse events reported during the trial
Safety outcome based on clinical assessment of the adverse events reported during the trial specifically related to the Hydroxycoll and compared to standard of care.
Measured: Week 6
Safety outcome based on clinical assessment of the adverse events reported during the trial
Safety outcome based on clinical assessment of the adverse events reported during the trial specifically related to the Hydroxycoll and compared to standard of care.
Measured: Week 12
Safety outcome based on clinical assessment of the adverse events reported during the trial
Safety outcome based on clinical assessment of the adverse events reported during the trial specifically related to the Hydroxycoll and compared to standard of care.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start30 Apr 2018
- Primary completion27 Dec 2019 (estimated)
- Study completion29 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SurgaColl Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Risebury, MA MBBS FRCS, Principal investigator, Hampshire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601130
- Sponsor's protocol ID
- SC100.2
- Acronym
- HColl_HTO
- Status last verified
- Jul 2018
- First submitted
- 3 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow up - Assessment of HydroxyColl Bone Graft Substitute in High Tibial Osteotomy Wedge Grafting.
- ClinicalTrials.gov ID
- NCT03601130
- Acronym / sponsor ID
- HColl_HTO / SC100.2
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteotomy, osteoarthritis, bone graft substitute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SurgaColl Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 27 Dec 2019 (estimated)
- Study completion
- 29 Apr 2020 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to demonstrate the safety and efficacy of Hydroxycoll bone graft substitute when used in the treatment of patients undergoing surgical treatment for varus mis-alignment in medial unicompartmental osteoarthritis of the knee. HydroxyColl bone graft substitute will be evaluated when utilized in Open Wedge High Tibial Osteotomy with medial plate fixation. Its safety profile will be evaluated as defined by the number of reported adverse events.
Detailed description
Osteoarthritis (OA) of the knee is joint damage, resulting in pain accompanied by varying degrees of functional limitation and reduced quality of life. 20% of adults over 50 and 40% over 80 years report disability from knee pain secondary to osteoarthritis.The majority of patients present to primary care with symptoms of pain and stiffness, which reduces mobility and with associated reduction in quality of life, with many patients not requiring surgery, with their symptoms adequately controlled by non-surgical measures. When patient's symptoms are not controlled by up to 3 months of non-operative treatment they become candidates for assessment for joint surgery. There are a number of surgical (Arthroscopy, Total/Partial Knee Replacement, High Tibial Osteotomy) and non-surgical (including exercise, weight loss, manual therapy, oral medication, injection therapy, splints and braces) options available. The decision to undergo surgery is based on patient symptom pattern, with the type of surgery determined by the pattern of joint damage and the patient's preference. High Tibial Osteotomy (HTO) should be considered primarily for patients with varus mis-alignment in medial unicompartmental osteoarthritis of the knee as the main indication for the procedure. HTO involves removing or adding bone to realign the limb and offload the knee. It is effective and can provide functional outcomes similar to those seen after joint replacement. HTO is a commonly used surgical procedure and has wide appeal because of the preservation of the knee joint. The principal advantages of opening wedge high tibial osteotomy include maintenance of the bone stock, correction of the deformity close to its origin, and no requirement for a fibular osteotomy. Although it is a good option for young patients with isolated medial compartment OA and varus deformity, it can be done even for older active people over 65. By preserving the patient's own knee anatomy, a successful osteotomy may delay the need for a joint replacement for several years. Another advantage is that there are no restrictions on physical activities after an osteotomy, even high impact exercise.
Contemporary Surgical approaches to HTO can often utilise bone graft substitutes to improve patient outcomes. Bone grafting in open wedge high tibial osteotomy (HTO) is an area of clinical research that requires further evaluation. While open wedge high tibial osteotomy (OWHTO) with medial plate fixation is a proven adequate and safe method for treatment of medial compartment osteoarthritis of the knee and varus deformity, particularly in young and/or active, it nevertheless creates a gap in the metaphysis of the tibia. To enhance bone healing and increase initial mechanical stability, a high degree HTO may require the application of bone graft/substitute to fill the osteotomy gap. Moreover, HTO has been associated with risk of nonunion, collapse and loss of correction. Autologous bone graft is the "gold standard" to fill the bone defect, but iliac crest graft harvest has risks. The associated complications include pain, thigh hypoesthesia, infection, pelvic bone fracture and discomfort wearing clothes. Allograft is commonly used to avoid the risks of autografting, such as donor side morbidity. However, the use of allograft increases additional risks such as disease transmission, immunologic reactions and slow remodelling. Due to the limited autologous bone availability and the problem of donor-site morbidity, many efforts have been made to find adequate supporting material for augmentation after osteotomy. Hydroxyapatite, β-tricalcium phosphate or the combination of both are the most commonly used synthetic augments in HTO. However, the most suitable material for filling the opening space in OWHTO has not been conclusively identified. While HTO with and without bone grafting has been assessed as radiologically equivalent, of particular interest to clinicians and patients is the contention around the secondary outcomes (site morbidity and bleeding, chronic pain, patient discomfort long term) which are frequently a challenge in postoperative management of patients. Autologous bone graft would still be the best choice for a lot of applications where bone grafting is needed but there are many disadvantages - the relatively high donor morbidity and the limited amount which can be harvested - which will eventually lead to a very restricted use of it. Allografts do not have these limitations, but in the form of demineralized bone matrix they have very variable osteoinductive properties and can possibly transmit diseases. Synthetic 2nd generation biomaterials have a long and safe history of use but do not provide a compelling alternative to traditional bone grafting. 3rd generation biomaterials as bone graft substitutes, such as HydroxyColl, offer exciting prospects of improved patient clinical outcomes and may provide a viable alternative to autologous bone grafts. Treatment for these patients would be with Open Wedge High Tibial Osteotomy with medial plate fixation. Over the period of the trial, adverse events will be reported by the study centre and it will be the prominence or absence of these, along with blood inflammatory marker evaluations that will determine the inherent safety of Hydroxycoll compared to the standard of care. At each follow up visit x-rays will be performed and evaluated by a certified radiologist. Site morbidity and bleeding will be clinically assessed. They will report and assess the radiographic images determining if healing has occurred. Along with the clinical assessment, the surgeon or a member of the clinical team will determine extent of healing. Patients will also self-report a number of key pain, mobility and post-operative joint inflammation outcomes.
The study is a single centre randomized blinded study to assess the efficacy and safety of Hydroxycoll bone graft substitute used as a bone graft substitute in Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care). This study has been designed to last for 52 weeks with follow up visits post surgery, 6 weeks, 12 weeks and a final follow-up at 52 weeks. In case of AEs/SAEs ongoing when the patient has completed the study, the patient will be contacted by phone one month after study completion for follow-up. The study will have 2 arms with 20 subjects per arm, each receiving at the time of surgical intervention either; 1) Open Wedge High Tibial Osteotomy with medial plate fixation (without bone grafting). 2) Open Wedge High Tibial Osteotomy with medial plate fixation (with bone grafting) using Hydroxycoll bone graft substitute. An Independent Review Board (IRB) will approve the protocol before the study begins. A clinical monitor selected by SurgaColl will monitor the trial. Any serious adverse events (SAE) will be reported as soon as possible (within 48 hours of awareness) to SurgaColl by the study centre. SurgaColl will communicate the SAE to all relevant authorities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Bone Graft | Other | Device: DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)Open Wedge High Tibial Osteotomy with medial plate fixation (without bone grafting) |
| HydroxyColl Bone Graft Substitute | Active comparator | Device: HydroxyColl Bone Graft Substitute, Device: DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)Open Wedge High Tibial Osteotomy with medial plate fixation (with bone grafting) using Hydroxycoll bone graft substitute. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Able to give written informed consent to participate in this study
- Both male and females who will be admitted to the hospital for treatment of varus mis-alignment in medial unicompartmental osteoarthritis of the knee of the degree to which the surgeon deems it necessary to include a bone grafting procedure
- Kellgren-Lawrence grade 1-4
- Ability and willingness to comply with all study requirements
Key exclusion criteria (13 listed)
- History or presence of the following conditions: known sensitivity to bovine collagen or hydroxyapatite materials; diabetes, immune-compromised, vascular disease, metabolic/systemic bone disorder, osteomyelitis
- Failure to provide written informed consent
- Severe acute or chronic medical illness, including symptomatic cardiovascular disease
- Weight less than 40 kilograms
- Any clinically significant abnormality at the time of submission, in the judgement of the investigator would preclude safe completion of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxyColl Bone Graft SubstituteThe intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) with the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute. | Device | HydroxyColl Bone Graft Substitute |
| DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)The intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) without the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute. | Device | HydroxyColl Bone Graft Substitute, No Bone Graft |
Primary outcome
Radiological Healing
Time frame: Week 6
clinical assessment of healing based on radiological observations by a member of the clinical team
Radiological Healing
Time frame: Week 12
clinical assessment of healing based on radiological observations by a member of the clinical team
Radiological Healing
Time frame: Week 52
clinical assessment of healing based on radiological observations by a member of the clinical team
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Day 0
Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Day 1
Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Week 6
Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Week 12
Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Week 52
Patient reported outcomes relating to knee pain and function (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL)). KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
EQ5D Score
Time frame: Day 0
Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.
EQ5D Score
Time frame: Day 1
Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.
EQ5D Score
Time frame: Week 6
Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.
EQ5D Score
Time frame: Week 12
Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.
EQ5D Score
Time frame: Week 52
Patient reported outcomes relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems.
VAS Score
Time frame: Day 0
Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].
VAS Score
Time frame: Day 1
Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].
VAS Score
Time frame: Week 6
Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].
VAS Score
Time frame: Week 12
Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].
VAS Score
Time frame: Week 52
Patient reported outcomes relating to pain. Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].
5 secondary outcomes
Safety outcome based on clinical assessment of the adverse events reported during the trial.
Time frame: Day 0
Safety outcome based on clinical assessment of the adverse events reported during the trial
Time frame: Day 1
Safety outcome based on clinical assessment of the adverse events reported during the trial
Time frame: Week 6
Safety outcome based on clinical assessment of the adverse events reported during the trial
Time frame: Week 12
Safety outcome based on clinical assessment of the adverse events reported during the trial
Time frame: Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Risebury, MA MBBS FRCS principal investigator
Hampshire Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HydroxyColl Bone Graft Substitute in people with Osteoarthritis, Knee, run by SurgaColl Technologies Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angie Dempster (+44 (0)1256 315073, Angie.Dempster@hhft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological Healing (time frame: Week 6). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.