Fracture Non UnionNCT03875963
Antibiotic Loaded Calcium Sulfate RCT
A study testing Antibiotic loaded bone filler in people with Fracture Non Union and Infection, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This is a multi-centered, prospective, randomized controlled trial comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Fracture Non Union, Infection
- What is being tested?
- Antibiotic loaded bone filler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2020to 23 Nov 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥16 years old.
- Isolated infected tibia defect or infected tibial nonunion (characterized by clinical symptoms present for greater than 90 days, the presence of necrotic bone, and bacteria cultured from prior procedures, surgical biopsy, or draining sinuses).
Who cannot join
- Presence of previous vascular injury or pathologic fracture
- Associated lower limb injuries that would interfere with rehabilitation or outcome
- Refusal to participate
- Inability to provide informed consent
- Inability to speak/understand or read English without a registered interpreter.
- Allergy or sensitivity to Vancomycin or Tobramycin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of Antibiotic Impregnated Calcium Sulfate: A Prospective Randomized Controlled Trial
This is a multi-centered, prospective, randomized controlled trial comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions.
Read the detailed description
There is a tremendous burden of disease associated with infected bone defects and infected nonunions and their management is challenging. Infected bone defects and nonunions have a profound clinical and economic impact and outcomes are limited by high rates of re-operation and poor functional outcomes. Reconstruction of infected bone defects or nonunions is difficult with multiple treatment options that may be considered. A comprehensive approach includes the treatment of infection, the management of dead space, skeletal stabilization, stimulation of soft tissue healing and healing of the bone defect or nonunion.
There is little evidence and a distinct lack of consensus regarding the definitive management of infected bone defects and infected nonunions. A two stage approach is still the gold standard for management and it remains unclear when alternative approaches should be considered. The first stage of the procedure includes adequate debridement, skeletal stabilization as required and placement of a polymethyl methacrylate cement spacer with or without antibiotics at the site of the bone defect. The second stage typically occurs between 6-8 weeks later with removal of the cement spacer and bone grafting into the preserved defect. There is no clear preferred management strategy and there remains a significant evidence gap.
There has been a significant interest in the use of bone graft substitutes for defect management as part of the management of infected bone defects and infected nonunions. The use of calcium sulfate as an alternative synthetic bone graft material has long been established (1-4), and the combination of calcium sulfate with antibiotics has been reported in the literature almost as long as antibiotics have been available (5, 6).
The clinical performance of calcium sulfate in combination with a single antibiotic, Tobramycin, is well documented (7, 8). However, in recent years, the use of calcium sulfate in combination with multiple antibiotics has grown in use as a means of providing protection from bacterial colonization by a wider variety of gram negative and gram positive pathogens (9-12). This study will evaluate the clinical performance of a high purity calcium sulfate bone void filler, STIMULAN® Rapid Cure. STIMULAN® Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). STIMULAN® Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing process. STIMULAN® Rapid Cure is biodegradable and biocompatible and may be used at an infected site.
The proposed study is a multi-centered, prospective, randomized controlled trial, comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions. Patients with an infected tibial bone defect or infected tibial nonunion meeting inclusion criteria will be randomized to receive either standard of care for defect management (Group A) or placement of antibiotic loaded Stimulan (10cc Stimulan Rapid Cure, 1g Vancomycin, 240mg Tobramycin) as a bone void filler (Group B), with a standardized intervention and post-intervention protocol.
- Conditions
- Fracture Non Union, Infection
- Being tested
- Antibiotic loaded bone filler
- Keywords
- Infection, Antibiotic bone cement, Tibia nonunion
- Medical subject headings
- Fractures, Ununited, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic loaded bone fillerOther
Defect management by placement of antibiotic loaded Stimulan as a bone void filler [calcium sulfate bone void filler (10 cc of STIMULAN(R) Rapid Cure, Biocomposites Ltd, UK) combined with the following antibiotic combination: 1g Vancomycin, 240mg Tobramycin].
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic loaded bone filler | Experimental | Patients will undergo irrigation and debridement, surgical stabilization as required, and defect management by placement of antibiotic loaded Stimulan as a bone void filler [calcium sulfate bone void filler (10 cc of STIMULAN(R) Rapid Cure, Biocomposites Ltd, UK) combined with the following antibiotic combination: 1g Vancomycin, 240mg Tobramycin]. The concurrent use of antibiotics is at the discretion of the treating physician. Receives: Other: Antibiotic loaded bone filler |
| Standard of care | No intervention | Current standard of care treatment for infected tibial defects or infected tibial nonunions includes treatment with irrigation and debridement, surgical stabilization as required, and defect management as required including placement of a polymethyl methacrylate spacer with or without antibiotics. A second procedure may or may not occur 6-8 weeks later with removal of the cement spacer and bone grafting into the preserved defect. Concurrent use of antibiotics is at the discretion of the treating physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of re-operations
Number of re-operations to obtain union or manage malunion, implant failure, or to eradicate infection.
Measured: 2 years post-injury
Secondary outcomes (7)
Numeric Pain Rating Scale
Pain measured using valid and reliable numeric pain rating scale. The scale measures the intensity of pain on a scale of 0 (meaning no pain) to 10 (worst pain). The scale asks the participant to rate the intensity of their pain in three ways -- their current pain level, their best pain level in the past 24 hours, and their worst pain level in the past 24 hours. The mean of all three scores is calculated by the research staff for a final average score. A lower score would indicate a better outcome, while a higher score would indicate a worse outcome.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Functional Index In Trauma (FIX-IT) Measure
The scale consists of two subscales - a weightbearing subscale and a pain subscale. The weight-baring subscale consists of two weight-bearing measures (Single Leg Score and Ambulation Score) and the pain subscale consists of two pain assessment measures (Palpation Score and Stress Score). Each of the four measures are rated on a scale from 0 to 3, with higher values representing a better outcome. For the weight bearing subscale, the Single Leg-Stand and the Ambulation Scores are added together, and for the pain subscale, the Palpation and the Stress Scores are added together for a total maximum score out of 6. The two subscales are added together at the end for a total maximum score of 12.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Patient reported outcomes
Short Musculoskeletal Function Assessment
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
EuroQol Group Quality of Life Scale with 5 Dimensions and 5 Levels (EQ-5D-5L)
The EuroQol5D-5L measures overall health and quality of life in 5 dimensions - Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression. Each subscale is given a score from 0 to 4, with higher scores representing a worse outcome. The 5 subscale scores are added together for a total maximum score out of 20. There is one additional question which asks the participant to rate their overall perceived health today on a scale from 0 to 100 with 0 representing the worst health they can imagine and 100 representing the best health they can imagine.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Number of patients with complications
Complications assessed will include nonunion, malunion, leg length discrepancy, infection, wound healing problems, and drainage
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Economic analysis
Ambulatory and Health Care Record to record economic burden on patient
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Radiographic assessment
- Anteroposterior and lateral tibial x-rays of all patients will be obtained at the standard follow-up intervals and will be blinded and scored by two established orthopaedic surgeons who are familiar with the RUST and modified RUST assessment scales b) Defect size pre-treatment will be measured using anteroposterior and lateral tibial x-rays
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Jan 2020
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Why it stopped: Sponsor decided not to pursue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Fracture Non UnionStudies 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
- Model description
- The proposed study is a multi-centered, prospective, randomized controlled trial, comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Biocomposites Ltd
- Responsible party
- Sponsor
- Investigators
- Emil Schemitsch, MD FRCS(C), Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875963
- Sponsor's protocol ID
- 5148
- Status last verified
- Dec 2023
- First submitted
- 13 Mar 2019
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
PELTIER LF. The use of plaster of paris to fill large defects in bone. Am J Surg. 1959 Mar;97(3):311-5. doi: 10.1016/0002-9610(59)90305-8. No abstract available.
PubMed 13627355PELTIER LF. The use of plaster of Paris to fill defects in bone. Clin Orthop. 1961;21:1-31. No abstract available.
PubMed 14485018PELTIER LF, BICKEL EY, LILLO R, THEIN MS. The use of plaster of paris to fill defects in bone. Ann Surg. 1957 Jul;146(1):61-9. doi: 10.1097/00000658-195707000-00007. No abstract available.
PubMed 13435702Peltier LF, Jones RH. Treatment of unicameral bone cysts by curettage and packing with plaster-of-Paris pellets. J Bone Joint Surg Am. 1978 Sep;60(6):820-2.
PubMed 701318KOVACEVIC B. [Problem of hematogenous osteomyelitis]. Langenbecks Arch Klin Chir Ver Dtsch Z Chir. 1953;276:432-43. No abstract available. Undetermined Language.
PubMed 13143827Fischer G, Seidler W. [Results in the treatment of osteomyelitic bone cavities using antibiotic gypsum medullary plombage]. Dtsch Gesundheitsw. 1971 Nov 4;26(45):2105-7. No abstract available. German.
PubMed 5145654McKee MD, Li-Bland EA, Wild LM, Schemitsch EH. A prospective, randomized clinical trial comparing an antibiotic-impregnated bioabsorbable bone substitute with standard antibiotic-impregnated cement beads in the treatment of chronic osteomyelitis and infected nonunion. J Orthop Trauma. 2010 Aug;24(8):483-90. doi: 10.1097/BOT.0b013e3181df91d9.
PubMed 20657257McKee MD, Wild LM, Schemitsch EH, Waddell JP. The use of an antibiotic-impregnated, osteoconductive, bioabsorbable bone substitute in the treatment of infected long bone defects: early results of a prospective trial. J Orthop Trauma. 2002 Oct;16(9):622-7. doi: 10.1097/00005131-200210000-00002.
PubMed 12368641Gauland C. Managing lower-extremity osteomyelitis locally with surgical debridement and synthetic calcium sulfate antibiotic tablets. Adv Skin Wound Care. 2011 Nov;24(11):515-23. doi: 10.1097/01.ASW.0000407647.12832.6c.
PubMed 22015750Jogia RM, Modha DE, Nisal K, Berrington R, Kong MF. Use of highly purified synthetic calcium sulfate impregnated with antibiotics for the management of diabetic foot ulcers complicated by osteomyelitis. Diabetes Care. 2015 May;38(5):e79-80. doi: 10.2337/dc14-3100. No abstract available.
PubMed 25908163
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Antibiotic Impregnated Calcium Sulfate: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03875963
- Acronym / sponsor ID
- 5148
- Conditions
- Fracture Non Union, Infection
- Keywords
- Infection, Antibiotic bone cement, Tibia nonunion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided not to pursue the study.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Biocomposites Ltd
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 15 Mar 2019 (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.
This is a multi-centered, prospective, randomized controlled trial comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions.
Detailed description
There is a tremendous burden of disease associated with infected bone defects and infected nonunions and their management is challenging. Infected bone defects and nonunions have a profound clinical and economic impact and outcomes are limited by high rates of re-operation and poor functional outcomes. Reconstruction of infected bone defects or nonunions is difficult with multiple treatment options that may be considered. A comprehensive approach includes the treatment of infection, the management of dead space, skeletal stabilization, stimulation of soft tissue healing and healing of the bone defect or nonunion.
There is little evidence and a distinct lack of consensus regarding the definitive management of infected bone defects and infected nonunions. A two stage approach is still the gold standard for management and it remains unclear when alternative approaches should be considered. The first stage of the procedure includes adequate debridement, skeletal stabilization as required and placement of a polymethyl methacrylate cement spacer with or without antibiotics at the site of the bone defect. The second stage typically occurs between 6-8 weeks later with removal of the cement spacer and bone grafting into the preserved defect. There is no clear preferred management strategy and there remains a significant evidence gap.
There has been a significant interest in the use of bone graft substitutes for defect management as part of the management of infected bone defects and infected nonunions. The use of calcium sulfate as an alternative synthetic bone graft material has long been established (1-4), and the combination of calcium sulfate with antibiotics has been reported in the literature almost as long as antibiotics have been available (5, 6).
The clinical performance of calcium sulfate in combination with a single antibiotic, Tobramycin, is well documented (7, 8). However, in recent years, the use of calcium sulfate in combination with multiple antibiotics has grown in use as a means of providing protection from bacterial colonization by a wider variety of gram negative and gram positive pathogens (9-12). This study will evaluate the clinical performance of a high purity calcium sulfate bone void filler, STIMULAN® Rapid Cure. STIMULAN® Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). STIMULAN® Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing process. STIMULAN® Rapid Cure is biodegradable and biocompatible and may be used at an infected site.
The proposed study is a multi-centered, prospective, randomized controlled trial, comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions. Patients with an infected tibial bone defect or infected tibial nonunion meeting inclusion criteria will be randomized to receive either standard of care for defect management (Group A) or placement of antibiotic loaded Stimulan (10cc Stimulan Rapid Cure, 1g Vancomycin, 240mg Tobramycin) as a bone void filler (Group B), with a standardized intervention and post-intervention protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The proposed study is a multi-centered, prospective, randomized controlled trial, comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions.
| Arm | Type | Receives |
|---|---|---|
| Antibiotic loaded bone filler | Experimental | Other: Antibiotic loaded bone fillerPatients will undergo irrigation and debridement, surgical stabilization as required, and defect management by placement of antibiotic loaded Stimulan as a bone void filler [calcium sulfate bone void filler (10 cc of STIMULAN(R) Rapid Cure, Biocomposites Ltd, UK) combined with the following antibiotic combination: 1g Vancomycin, 240mg Tobramycin]. The concurrent use of antibiotics is at the discretion of the treating physician. |
| Standard of care | No intervention | –Current standard of care treatment for infected tibial defects or infected tibial nonunions includes treatment with irrigation and debridement, surgical stabilization as required, and defect management as required including placement of a polymethyl methacrylate spacer with or without antibiotics. A second procedure may or may not occur 6-8 weeks later with removal of the cement spacer and bone grafting into the preserved defect. Concurrent use of antibiotics is at the discretion of the treating physician. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ≥16 years old.
- Isolated infected tibia defect or infected tibial nonunion (characterized by clinical symptoms present for greater than 90 days, the presence of necrotic bone, and bacteria cultured from prior procedures, surgical biopsy, or draining sinuses).
Key exclusion criteria (6 listed)
- Presence of previous vascular injury or pathologic fracture
- Associated lower limb injuries that would interfere with rehabilitation or outcome
- Refusal to participate
- Inability to provide informed consent
- Inability to speak/understand or read English without a registered interpreter.
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 |
|---|---|---|
| Antibiotic loaded bone fillerDefect management by placement of antibiotic loaded Stimulan as a bone void filler [calcium sulfate bone void filler (10 cc of STIMULAN(R) Rapid Cure, Biocomposites Ltd, UK) combined with the following antibiotic combination: 1g Vancomycin, 240mg Tobramycin]. | Other | Antibiotic loaded bone filler |
Primary outcome
Number of re-operations
Time frame: 2 years post-injury
Number of re-operations to obtain union or manage malunion, implant failure, or to eradicate infection.
7 secondary outcomes
Numeric Pain Rating Scale
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Functional Index In Trauma (FIX-IT) Measure
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Patient reported outcomes
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
EuroQol Group Quality of Life Scale with 5 Dimensions and 5 Levels (EQ-5D-5L)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Number of patients with complications
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Economic analysis
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Radiographic assessment
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Results and safety
The study was stopped early (reason given: Sponsor decided not to pursue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Background: PubMed 13627355PELTIER LF. The use of plaster of paris to fill large defects in bone. Am J Surg. 1959 Mar;97(3):311-5. doi: 10.1016/0002-9610(59)90305-8. No abstract available.
- Background: PubMed 14485018PELTIER LF. The use of plaster of Paris to fill defects in bone. Clin Orthop. 1961;21:1-31. No abstract available.
- Background: PubMed 13435702PELTIER LF, BICKEL EY, LILLO R, THEIN MS. The use of plaster of paris to fill defects in bone. Ann Surg. 1957 Jul;146(1):61-9. doi: 10.1097/00000658-195707000-00007. No abstract available.
- Background: PubMed 701318Peltier LF, Jones RH. Treatment of unicameral bone cysts by curettage and packing with plaster-of-Paris pellets. J Bone Joint Surg Am. 1978 Sep;60(6):820-2.
- Background: PubMed 13143827KOVACEVIC B. [Problem of hematogenous osteomyelitis]. Langenbecks Arch Klin Chir Ver Dtsch Z Chir. 1953;276:432-43. No abstract available. Undetermined Language.
- Background: PubMed 5145654Fischer G, Seidler W. [Results in the treatment of osteomyelitic bone cavities using antibiotic gypsum medullary plombage]. Dtsch Gesundheitsw. 1971 Nov 4;26(45):2105-7. No abstract available. German.
- Background: PubMed 20657257McKee MD, Li-Bland EA, Wild LM, Schemitsch EH. A prospective, randomized clinical trial comparing an antibiotic-impregnated bioabsorbable bone substitute with standard antibiotic-impregnated cement beads in the treatment of chronic osteomyelitis and infected nonunion. J Orthop Trauma. 2010 Aug;24(8):483-90. doi: 10.1097/BOT.0b013e3181df91d9.
- Background: PubMed 12368641McKee MD, Wild LM, Schemitsch EH, Waddell JP. The use of an antibiotic-impregnated, osteoconductive, bioabsorbable bone substitute in the treatment of infected long bone defects: early results of a prospective trial. J Orthop Trauma. 2002 Oct;16(9):622-7. doi: 10.1097/00005131-200210000-00002.
- Background: PubMed 22015750Gauland C. Managing lower-extremity osteomyelitis locally with surgical debridement and synthetic calcium sulfate antibiotic tablets. Adv Skin Wound Care. 2011 Nov;24(11):515-23. doi: 10.1097/01.ASW.0000407647.12832.6c.
- Background: PubMed 25908163Jogia RM, Modha DE, Nisal K, Berrington R, Kong MF. Use of highly purified synthetic calcium sulfate impregnated with antibiotics for the management of diabetic foot ulcers complicated by osteomyelitis. Diabetes Care. 2015 May;38(5):e79-80. doi: 10.2337/dc14-3100. No abstract available.
- Individual participant dataSharing planned: No
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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.
Emil Schemitsch, MD FRCS(C) principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic loaded bone filler in people with Fracture Non Union and Infection, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Dec 2023. 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 Canada. 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?
The study was stopped early (reason given: Sponsor decided not to pursue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of re-operations (time frame: 2 years post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03875963, which also lists 10 linked publications.
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 18 Dec 2023.