Osteochondral Lesion of TalusOUTBACKNCT04475341
Osteochondral Lesions Under 15mm2 of the Talus; is Iliac Crest Bone Marrow Aspirate Concentrate the Key to Success?
A study testing BMS + Bone Marrow Aspirate Concentrate and BMS alone in people with Osteochondral Lesion of Talus, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed conservative management, surgical intervention may be necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteochondral Lesion of Talus
- What is being tested?
- BMS + Bone Marrow Aspirate Concentrate and BMS alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 2 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a symptomatic OCL of the talus who are scheduled for arthroscopic debridement and microfracture
- OCL depth and/or diameter ≤ 15 mm on computed tomography medial-lateral and/or anterior-posterior
- Age 18 years or older
- Intact remaining articular cartilage of the joint Kellgren-Lawrence stage 0-1
Who cannot join
- Concomitant OCL of the tibia
- Ankle osteoarthritis grade 2 or 3 van Dijk et al. [53]
- Ankle fracture < 6 months before scheduled arthroscopy
- Inflammatory arthropathy (e.g Rheumatoid arthritis)
- History of (or current) hemopoeitic disease or immunotherapy
- Acute or chronic instability of the ankle
Show all 14Show fewer
- Use of prescribed orthopaedic shoewear
- Other concomitant painful or disabling disease of the lower limb
- Pregnancy
- Implanted pacemaker
- Participation in previous trials < 1 year, in which the subject has been exposed to radiation (radiographs or CT)
- Patients who are unable to fill out questionnaires and cannot have them filled out
- No informed consent
- HIV positive or hepatitis B or C infection (based on the anamnesis of the patient)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 'A Randomized Clinical Trial on the Clinical Efficacy of Bone Marrow Stimulation Combined With the Insertion of Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Small Primary and Non-primary Talar Osteochondral Lesions'
Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed conservative management, surgical intervention may be necessary. For small cystic defects the current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell population from the underlying bone marrow. This procedure has been reported to have a 75% successful long-term outcome. Recently, the additional use of biological adjuncts has become popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may therefore theoretically improve the quality of subchondral plate and cartilage repair. The current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in comparison to BMS alone.
Read the detailed description
Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed conservative management, surgical intervention may be necessary. For small cystic defects the current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell population from the underlying bone marrow. This procedure has been reported to have a 75% successful long-term outcome. Recently, the additional use of biological adjuncts has become popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may therefore theoretically improve the quality of subchondral plate and cartilage repair. The current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in comparison to BMS alone.
- Conditions
- Osteochondral Lesion of Talus
- Being tested
- BMS + Bone Marrow Aspirate Concentrate, BMS alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS + Bone Marrow Aspirate ConcentrateBiological
Both groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD.
BMS aloneProcedure or surgery
Both groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD.
| Study group | Role | What they receive |
|---|---|---|
| BMS without BMAC | Active comparator | Not described Receives: Procedure: BMS alone |
| BMS with BMAC | Experimental | Not described Receives: Biological: BMS + Bone Marrow Aspirate Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale of Pain During Weightbearing
Measured: 2 years post-operatively
Secondary outcomes (57)
EQ5D
Measured: pre-operatively
EQ5D
Measured: three months postoperatively
EQ5D
Measured: one-year post-operatively
EQ5D
Measured: two years post-operatively
AOFAS
American Orthopaedic Foot and Ankle Score (AOFAS)
Measured: preoperatively
AOFAS
American Orthopaedic Foot and Ankle Score (AOFAS)
Measured: three months postoperatively
AOFAS
American Orthopaedic Foot and Ankle Score (AOFAS)
Measured: one-year post-operatively
AOFAS
American Orthopaedic Foot and Ankle Score (AOFAS)
Measured: two years post-operatively
FAOS
Foot and Ankle Outcome Score
Measured: pre-operatively
FAOS
Foot and Ankle Outcome Score
Measured: three months
FAOS
Foot and Ankle Outcome Score
Measured: one-year post-operatively
FAOS
Foot and Ankle Outcome Score
Measured: two years post-operatively
NRS in rest
Numeric Rating Scale of Pain During Rest
Measured: pre-operatively
NRS in rest
Numeric Rating Scale of Pain During Rest
Measured: 3 months postoperatively
NRS in rest
Numeric Rating Scale of Pain During Rest
Measured: 1 year postoperatively
NRS in rest
Numeric Rating Scale of Pain During Rest
Measured: 2 years postoperatively
NRS during running
Numeric Rating Scale of Pain During Running
Measured: pre-operatively
NRS during running
Numeric Rating Scale of Pain During Running
Measured: 3 months postoperatively
NRS during running
Numeric Rating Scale of Pain During Running
Measured: 1 year postoperatively
NRS during running
Numeric Rating Scale of Pain During Running
Measured: 2 years postoperatively
NRS during stair-climbing
Numeric Rating Scale of Pain During Stair-Climbing
Measured: pre-operatively
NRS during stair-climbing
Numeric Rating Scale of Pain During Stair-Climbing
Measured: 3 months postoperatively
NRS during stair-climbing
Numeric Rating Scale of Pain During Stair-Climbing
Measured: 1 year postoperatively
NRS during stair-climbing
Numeric Rating Scale of Pain During Stair-Climbing
Measured: 2 years postoperatively
NRS during performing sports
Numeric Rating Scale of Pain During Sports
Measured: pre-operatively
NRS during performing sports
Numeric Rating Scale of Pain During Sports
Measured: 3 months post-operatively
NRS during performing sports
Numeric Rating Scale of Pain During Sports
Measured: 1 year post-operatively
NRS during performing sports
Numeric Rating Scale of Pain During Sports
Measured: 2 years post-operatively
NRS during weight-bearing
Numeric Rating Scale of Pain During Weightbearing
Measured: pre-operatively
NRS during weight-bearing
Numeric Rating Scale of Pain During Weightbearing
Measured: 3 months postoperatively
NRS during weight-bearing
Numeric Rating Scale of Pain During Weightbearing
Measured: 1 year post-operativley
FAAM
Foot and Ankle Ability Measure
Measured: pre-operatively
FAAM
Foot and Ankle Ability Measure
Measured: 3 months postoperatively
FAAM
Foot and Ankle Ability Measure
Measured: 1 year postoperatively
FAAM
Foot and Ankle Ability Measure
Measured: 2 years postoperatively
SF-12
Short-Form 12
Measured: pre-operatively
SF-12
Short-Form 12
Measured: 3 months postoperatively
SF-12
Measured: 1 year postoperatively
SF-12
Short-Form 12
Measured: 2 years postoperatively
Ankle Activity Scale (AAS)
Measured: pre-operatively
Ankle Activity Scale (AAS)
Measured: 3 months postoperatively
Ankle Activity Scale (AAS)
Measured: 1 year post-operatively
Ankle Activity Scale (AAS)
Measured: 2 year post-operatively
Return to sports
Measured: post-operatively until 2 years of follow-up post-operatively
Return to work
Measured: post-operatively until 2 years of follow-up post-operatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Measured: pre-operatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Measured: 2 weeks postoperatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Measured: 1 year postoperatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Measured: 2 years postoperatively
Radiological outcomes: MRI scan (T2 relaxation times)
Measured: Pre-operatively
Radiological outcomes: MRI scan (T2 relaxation times)
Measured: 1 year post-operatively
Radiological outcomes: MRI scan (T2 relaxation times)
Measured: 2 years post-operatively
Cost-effectiviness
all relevant clinical costs will be scored through a patient diary
Measured: From per-operatively to post-operatively at 2 years (one period)
Cell-subset analysis
protein analyses will be performed by Sanquin
Measured: per-operatively
Demographic data
all kinds of demographic data will be assessed (age, gender, etc.)
Measured: Pre-operatively
Complications
all types of complications
Measured: From per-operatively to post-operatively at 2 years (one period)
Re-operations
re-operations will be assessed
Measured: From per-operatively to post-operatively at 2 years (one period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion2 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Lesion of TalusStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jari Dahmen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475341
- Sponsor's protocol ID
- GK2019OUTBACK
- Acronym
- OUTBACK
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'A Randomized Clinical Trial on the Clinical Efficacy of Bone Marrow Stimulation Combined With the Insertion of Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Small Primary and Non-primary Talar Osteochondral Lesions'
- ClinicalTrials.gov ID
- NCT04475341
- Acronym / sponsor ID
- OUTBACK / GK2019OUTBACK
- Conditions
- Osteochondral Lesion of Talus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 2 Sep 2024 (estimated)
- First posted
- 17 Jul 2020 (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.
Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed conservative management, surgical intervention may be necessary. For small cystic defects the current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell population from the underlying bone marrow. This procedure has been reported to have a 75% successful long-term outcome. Recently, the additional use of biological adjuncts has become popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may therefore theoretically improve the quality of subchondral plate and cartilage repair. The current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in comparison to BMS alone.
Detailed description
Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed conservative management, surgical intervention may be necessary. For small cystic defects the current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell population from the underlying bone marrow. This procedure has been reported to have a 75% successful long-term outcome. Recently, the additional use of biological adjuncts has become popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may therefore theoretically improve the quality of subchondral plate and cartilage repair. The current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in comparison to BMS alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS without BMAC | Active comparator | Procedure: BMS alone |
| BMS with BMAC | Experimental | Biological: BMS + Bone Marrow Aspirate Concentrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a symptomatic OCL of the talus who are scheduled for arthroscopic debridement and microfracture
- OCL depth and/or diameter ≤ 15 mm on computed tomography medial-lateral and/or anterior-posterior
- Age 18 years or older
- Intact remaining articular cartilage of the joint Kellgren-Lawrence stage 0-1
Key exclusion criteria (14 listed)
- Concomitant OCL of the tibia
- Ankle osteoarthritis grade 2 or 3 van Dijk et al. [53]
- Ankle fracture < 6 months before scheduled arthroscopy
- Inflammatory arthropathy (e.g Rheumatoid arthritis)
- History of (or current) hemopoeitic disease or immunotherapy
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 |
|---|---|---|
| BMS + Bone Marrow Aspirate ConcentrateBoth groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD. | Biological | BMS with BMAC |
| BMS aloneBoth groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD. | Procedure or surgery | BMS without BMAC |
Primary outcome
Numeric Rating Scale of Pain During Weightbearing
Time frame: 2 years post-operatively
57 secondary outcomes
EQ5D
Time frame: pre-operatively
EQ5D
Time frame: three months postoperatively
EQ5D
Time frame: one-year post-operatively
EQ5D
Time frame: two years post-operatively
AOFAS
Time frame: preoperatively
AOFAS
Time frame: three months postoperatively
AOFAS
Time frame: one-year post-operatively
AOFAS
Time frame: two years post-operatively
FAOS
Time frame: pre-operatively
FAOS
Time frame: three months
FAOS
Time frame: one-year post-operatively
FAOS
Time frame: two years post-operatively
NRS in rest
Time frame: pre-operatively
NRS in rest
Time frame: 3 months postoperatively
NRS in rest
Time frame: 1 year postoperatively
NRS in rest
Time frame: 2 years postoperatively
NRS during running
Time frame: pre-operatively
NRS during running
Time frame: 3 months postoperatively
NRS during running
Time frame: 1 year postoperatively
NRS during running
Time frame: 2 years postoperatively
NRS during stair-climbing
Time frame: pre-operatively
NRS during stair-climbing
Time frame: 3 months postoperatively
NRS during stair-climbing
Time frame: 1 year postoperatively
NRS during stair-climbing
Time frame: 2 years postoperatively
NRS during performing sports
Time frame: pre-operatively
NRS during performing sports
Time frame: 3 months post-operatively
NRS during performing sports
Time frame: 1 year post-operatively
NRS during performing sports
Time frame: 2 years post-operatively
NRS during weight-bearing
Time frame: pre-operatively
NRS during weight-bearing
Time frame: 3 months postoperatively
NRS during weight-bearing
Time frame: 1 year post-operativley
FAAM
Time frame: pre-operatively
FAAM
Time frame: 3 months postoperatively
FAAM
Time frame: 1 year postoperatively
FAAM
Time frame: 2 years postoperatively
SF-12
Time frame: pre-operatively
SF-12
Time frame: 3 months postoperatively
SF-12
Time frame: 1 year postoperatively
SF-12
Time frame: 2 years postoperatively
Ankle Activity Scale (AAS)
Time frame: pre-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Osteochondral Lesion of Talus
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
Active, not recruiting
Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
Osteochondral Defect
Recruiting
Talar Osteochondral Lesions With Pilon Fractures
Pilon Fractures
Active, not recruitingObservational study
Ten Years Follow-up After the Arthroscopic Repair of Osteochondral Lesions of the Talus Via Autologous Matrix-induced Chondrogenesis (AMIC)
Osteochondral Defect of Talus
Enrolling by invitation
Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
Osteochondral; Defect
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.
Questions about this trial
What is this clinical trial studying?
A study testing BMS + Bone Marrow Aspirate Concentrate and BMS alone in people with Osteochondral Lesion of Talus, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 14 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 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jari Dahmen, MD, BSc (+31638522988, j.dahmen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale of Pain During Weightbearing (time frame: 2 years post-operatively). 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 17 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.