Osteoarthritis, KneePhase 4NCT02000297
Outcome Comparison of Allograft and Synthetic Bone Substitute in High Tibial Osteotomy
A Phase 4 study testing Allogenic bone graft and Synthetic bone substitute (geneX®) in people with Osteoarthritis, Knee, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is conducted to determine whether a new synthetic bone substitute is better than allogenic bone graft for addressing bone defect in medial open wedge high tibial osteotomy in terms of postoperative pain, postoperative bleeding, operation time and bone healing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Allogenic bone graft and Synthetic bone substitute (geneX®)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Jan 2016
- Phase
- Phase 4
- 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
- Diagnosis of primary osteoarthritis of the knee which is confined to medial compartment
- Scheduled for high tibial osteotomy
- Written signed consent available
Who cannot join
- Patients who refuse to participate in the study
- Previous history of major orthopedic surgery around the operating knee
- Congenital anomaly involving proximal tibia
- Revision high tibial osteotomy
- Patients who is receiving another major knee surgery simultaneously with high tibial osteotomy at the same knee
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Tae Kyun Kim, MD, PhD, 82-31-787-7196, osktk@snubh.org
About this study
Official title: Outcome Comparison of Allogenic Cancellous Bone and a New Synthetic Bone Substitute (geneX®) in Filling the Bone Defect Created With Medial Open Wedge High Tibial Osteotomy
This study is conducted to determine whether a new synthetic bone substitute is better than allogenic bone graft for addressing bone defect in medial open wedge high tibial osteotomy in terms of postoperative pain, postoperative bleeding, operation time and bone healing. The investigators hypothesized the new synthetic bone substitute would bring better outcomes in the outcome variables mentioned above.
Read the detailed description
High tibial osteotomy is a well-established treatment option for the young patients (aged 40~55years) with knee osteoarthritis which is confined in medial compartment of the knee. Classical technique was lateral closing wedge osteotomy, but recently medial open wedge osteotomy has gained popularity with the advent of new fixation devices and refined surgical techniques. The surgeon can correct the deformity more precisely in both coronal and sagittal planes simultaneously with medial opening technique. And it can avoid complications associated with lateral closing technique like tibial shaft offset or peroneal nerve palsy. But medial opening technique inevitably creates large bone defect, which has to be addressed to avoid complications like loss of correction or delayed/non-union. Autologous bone is widely accepted as a standard for filling bone defects, but its supply is limited and harvesting autologous bone adds to surgical morbidity like bleeding, pain or fracture at the donor site. Therefore, there has been much effort to find materials to substitute autologous bone. Many studies reported the results of using allogenic bone for addressing bone defects and most of them showed favorable results. But some allogenic bone products are cumbersome to process to make it fit to the defect, and there are potential risk of disease transmission, if the products are not properly treated. Bone cements of several different composition has been developed and when used for filling bone defect, they also showed good results in general. Recently, a new synthetic bone substitute based on calcium phosphate and calcium sulfate (geneX®, Biocomposites Co.,Ltd.) has been introduced and is commercially available. While providing initial mechanical strength, its calcium sulfate component is rapidly absorbed to provide space for new bone ingrowth and its surface is made to negatively charged, which helps accelerate new bone formation. It is provided as an injectable paste, which is easier to handle than allogenic bone, so it may help reduce operation time. With these theoretical advantages, there are some anecdotal reports that patients treated with geneX® presented less postoperative pain and bleeding than patients treated with allogenic bone graft. Therefore, we conducted this study to determine whether the new synthetic bone substitute (geneX®) is better than allogenic bone for addressing bone defect created in medial open wedge high tibial osteotomy.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Allogenic bone graft, Synthetic bone substitute (geneX®)
- Keywords
- Osteoarthritis, Knee, High tibial osteotomy, Calcium phosphate, Calcium sulfate
- 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.
Allogenic bone graftProcedure or surgery
Patients in this arm is treated with allogenic bone graft to fill the bone defect created with medial open wedge high tibial osteotomy
Synthetic bone substitute (geneX®)Procedure or surgery
Patients in this arm is treated with synthetic bone substitute (geneX®) to fill the bone defect created with medial open wedge high tibial osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Allogenic bone graft group | Active comparator | Patients in this arm is treated with allogenic bone graft to fill the bone defect created with medial open wedge high tibial osteotomy Receives: Procedure: Allogenic bone graft |
| Synthetic bone substitute (geneX®) group | Experimental | Patients in this arm is treated with synthetic bone substitute(geneX®) to fill the bone defect created with medial open wedge high tibial osteotomy Receives: Procedure: Synthetic bone substitute (geneX®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal change of postoperative pain
Pain on operation site is measured on a 0-to-10 visual analogue scale(VAS) and 5-point Likert scale (0.no pain, 1.slight pain, 2.moderate pain, 3.severe pain, 4.extreme pain).
Initial postoperative pain will be recorded on postoperative day 2. After discharge from hospital (on postoperative day 2, on average), patients will visit outpatient department on 2weeks, 6weeks, 3months, 6months, 12months after surgery and pain measurements on each visit will be recorded.
Measured: from 2 days after surgery to 12 months after surgery
Secondary outcomes (7)
Pre&postoperative Hemoglobin level
Preoperative hemoglobin level is measured when the patient is admitted to the hospital for surgery and postoperative level is measured on postoperative day 2. The differences between values will be calculated.
Measured: on admission (preop.), postoperative day 2 (postop.)
Total operation time
Total operation time is defined as the time interval between skin incision and deflation of tourniquet (thigh tourniquet used in the operation to provide bloodless surgical field). Measured in minutes.
Measured: from skin incision to deflation of tourniquet
Temporal change of weight bearing status
As a proxy variable of bone healing status, whether the patient can bear weight on operated knee is measured on a 3 point scale (1.full weight bearing, 2.partial weight bearing, 3.no weight bearing)
Patients will visit outpatient department on 2weeks, 6weeks, 3months, 6months, 12months after surgery and weight bearing status on each visit will be recorded.
Measured: from 2 weeks after surgery to 12 months after surgery
Temporal change of pain with weight bearing
As a proxy variable of bone healing status, pain with weight bearing is measured on a 0-to-10 visual analogue scale(VAS) and 5-point Likert scale (0.no pain, 1.slight pain, 2.moderate pain, 3.severe pain, 4.extreme pain)
Patients will visit outpatient department on 2weeks, 6weeks, 3months, 6months, 12months after surgery and pain with weight bearing on each visit will be recorded.
Measured: from 2 weeks after surgery to 12 months after surgery
Amount of drainage
Total amount of drainage (in milliliters) from indwelling drain located in operative site, until its removal.
Measured: from the end of surgery until drain removal, which is anticipated on postoperative day 1 or 2
Working time for bone defect filling
Time required to fill the bone defect (from the start of processing either allogenic bone graft or synthetic bone substitute to completely finish filling the defect. Measured in seconds.
Measured: from the start of processing allograft or synthetic bone substitute to finish filling bone defect
Temporal progression of bone healing on X-rays
Two independent investigators assess the progression of bone healing status on X-rays and the agreement between investigators will be measured. Bone healing status is assessed based on 3 point scale. (1. union not achieved yet, 2. partial union achieved, 3. complete union achieved)
Patients will visit outpatient department on 2weeks, 6weeks, 3months, 6months, 12months after surgery and bone healing status on X-rays will be recorded on 3months, 6months and 12months after surgery.
Measured: from 3 months after surgery to 12months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2015 (estimated)
- Study completionJan 2016 (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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyun Kim, Seoul National University Hospital
- Investigators
- Tae Kyun Kim, MD, PhD, Principal investigator, Joint Reconstruction Center, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000297
- Sponsor's protocol ID
- B-1309/220-005
- Status last verified
- Oct 2014
- First submitted
- 11 Nov 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Comparison of Allogenic Cancellous Bone and a New Synthetic Bone Substitute (geneX®) in Filling the Bone Defect Created With Medial Open Wedge High Tibial Osteotomy
- ClinicalTrials.gov ID
- NCT02000297
- Acronym / sponsor ID
- B-1309/220-005
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, High tibial osteotomy, Calcium phosphate, Calcium sulfate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 4 Dec 2013 (estimated)
- 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.
This study is conducted to determine whether a new synthetic bone substitute is better than allogenic bone graft for addressing bone defect in medial open wedge high tibial osteotomy in terms of postoperative pain, postoperative bleeding, operation time and bone healing. The investigators hypothesized the new synthetic bone substitute would bring better outcomes in the outcome variables mentioned above.
Detailed description
High tibial osteotomy is a well-established treatment option for the young patients (aged 40~55years) with knee osteoarthritis which is confined in medial compartment of the knee. Classical technique was lateral closing wedge osteotomy, but recently medial open wedge osteotomy has gained popularity with the advent of new fixation devices and refined surgical techniques. The surgeon can correct the deformity more precisely in both coronal and sagittal planes simultaneously with medial opening technique. And it can avoid complications associated with lateral closing technique like tibial shaft offset or peroneal nerve palsy. But medial opening technique inevitably creates large bone defect, which has to be addressed to avoid complications like loss of correction or delayed/non-union. Autologous bone is widely accepted as a standard for filling bone defects, but its supply is limited and harvesting autologous bone adds to surgical morbidity like bleeding, pain or fracture at the donor site. Therefore, there has been much effort to find materials to substitute autologous bone. Many studies reported the results of using allogenic bone for addressing bone defects and most of them showed favorable results. But some allogenic bone products are cumbersome to process to make it fit to the defect, and there are potential risk of disease transmission, if the products are not properly treated. Bone cements of several different composition has been developed and when used for filling bone defect, they also showed good results in general. Recently, a new synthetic bone substitute based on calcium phosphate and calcium sulfate (geneX®, Biocomposites Co.,Ltd.) has been introduced and is commercially available. While providing initial mechanical strength, its calcium sulfate component is rapidly absorbed to provide space for new bone ingrowth and its surface is made to negatively charged, which helps accelerate new bone formation. It is provided as an injectable paste, which is easier to handle than allogenic bone, so it may help reduce operation time. With these theoretical advantages, there are some anecdotal reports that patients treated with geneX® presented less postoperative pain and bleeding than patients treated with allogenic bone graft. Therefore, we conducted this study to determine whether the new synthetic bone substitute (geneX®) is better than allogenic bone for addressing bone defect created in medial open wedge high tibial osteotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogenic bone graft group | Active comparator | Procedure: Allogenic bone graftPatients in this arm is treated with allogenic bone graft to fill the bone defect created with medial open wedge high tibial osteotomy |
| Synthetic bone substitute (geneX®) group | Experimental | Procedure: Synthetic bone substitute (geneX®)Patients in this arm is treated with synthetic bone substitute(geneX®) to fill the bone defect created with medial open wedge high tibial osteotomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary osteoarthritis of the knee which is confined to medial compartment
- Scheduled for high tibial osteotomy
- Written signed consent available
Key exclusion criteria (5 listed)
- Patients who refuse to participate in the study
- Previous history of major orthopedic surgery around the operating knee
- Congenital anomaly involving proximal tibia
- Revision high tibial osteotomy
- Patients who is receiving another major knee surgery simultaneously with high tibial osteotomy at the same knee
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 |
|---|---|---|
| Allogenic bone graftPatients in this arm is treated with allogenic bone graft to fill the bone defect created with medial open wedge high tibial osteotomy | Procedure or surgery | Allogenic bone graft group |
| Synthetic bone substitute (geneX®)Patients in this arm is treated with synthetic bone substitute (geneX®) to fill the bone defect created with medial open wedge high tibial osteotomy | Procedure or surgery | Synthetic bone substitute (geneX®) group |
Primary outcome
Temporal change of postoperative pain
Time frame: from 2 days after surgery to 12 months after surgery
Pain on operation site is measured on a 0-to-10 visual analogue scale(VAS) and 5-point Likert scale (0.no pain, 1.slight pain, 2.moderate pain, 3.severe pain, 4.extreme pain). Initial postoperative pain will be recorded on postoperative day 2. After discharge from hospital (on postoperative day 2, on average), patients will visit outpatient department on 2weeks, 6weeks, 3months, 6months, 12months after surgery and pain measurements on each visit will be recorded.
7 secondary outcomes
Pre&postoperative Hemoglobin level
Time frame: on admission (preop.), postoperative day 2 (postop.)
Total operation time
Time frame: from skin incision to deflation of tourniquet
Temporal change of weight bearing status
Time frame: from 2 weeks after surgery to 12 months after surgery
Temporal change of pain with weight bearing
Time frame: from 2 weeks after surgery to 12 months after surgery
Amount of drainage
Time frame: from the end of surgery until drain removal, which is anticipated on postoperative day 1 or 2
Working time for bone defect filling
Time frame: from the start of processing allograft or synthetic bone substitute to finish filling bone defect
Temporal progression of bone healing on X-rays
Time frame: from 3 months after surgery to 12months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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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.
Tae Kyun Kim, MD, PhD principal investigator
Joint Reconstruction Center, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allogenic bone graft and Synthetic bone substitute (geneX®) in people with Osteoarthritis, Knee, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 5 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 15 Oct 2014. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tae Kyun Kim, MD, PhD (82-31-787-7196, osktk@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal change of postoperative pain (time frame: from 2 days after surgery to 12 months after surgery). 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 15 Oct 2014.