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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Jari Dahmen, MD, BSc contact

+31638522988

j.dahmen@amsterdamumc.nl

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.

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 groups in NCT04475341
Study groupRoleWhat they receive
BMS without BMACActive comparatorNot described
Receives: Procedure: BMS alone
BMS with BMACExperimentalNot 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.

  1. Numeric Rating Scale of Pain During Weightbearing

    Measured: 2 years post-operatively

Secondary outcomes (57)

  1. EQ5D

    Measured: pre-operatively

  2. EQ5D

    Measured: three months postoperatively

  3. EQ5D

    Measured: one-year post-operatively

  4. EQ5D

    Measured: two years post-operatively

  5. AOFAS

    American Orthopaedic Foot and Ankle Score (AOFAS)

    Measured: preoperatively

  6. AOFAS

    American Orthopaedic Foot and Ankle Score (AOFAS)

    Measured: three months postoperatively

  7. AOFAS

    American Orthopaedic Foot and Ankle Score (AOFAS)

    Measured: one-year post-operatively

  8. AOFAS

    American Orthopaedic Foot and Ankle Score (AOFAS)

    Measured: two years post-operatively

  9. FAOS

    Foot and Ankle Outcome Score

    Measured: pre-operatively

  10. FAOS

    Foot and Ankle Outcome Score

    Measured: three months

  11. FAOS

    Foot and Ankle Outcome Score

    Measured: one-year post-operatively

  12. FAOS

    Foot and Ankle Outcome Score

    Measured: two years post-operatively

  13. NRS in rest

    Numeric Rating Scale of Pain During Rest

    Measured: pre-operatively

  14. NRS in rest

    Numeric Rating Scale of Pain During Rest

    Measured: 3 months postoperatively

  15. NRS in rest

    Numeric Rating Scale of Pain During Rest

    Measured: 1 year postoperatively

  16. NRS in rest

    Numeric Rating Scale of Pain During Rest

    Measured: 2 years postoperatively

  17. NRS during running

    Numeric Rating Scale of Pain During Running

    Measured: pre-operatively

  18. NRS during running

    Numeric Rating Scale of Pain During Running

    Measured: 3 months postoperatively

  19. NRS during running

    Numeric Rating Scale of Pain During Running

    Measured: 1 year postoperatively

  20. NRS during running

    Numeric Rating Scale of Pain During Running

    Measured: 2 years postoperatively

  21. NRS during stair-climbing

    Numeric Rating Scale of Pain During Stair-Climbing

    Measured: pre-operatively

  22. NRS during stair-climbing

    Numeric Rating Scale of Pain During Stair-Climbing

    Measured: 3 months postoperatively

  23. NRS during stair-climbing

    Numeric Rating Scale of Pain During Stair-Climbing

    Measured: 1 year postoperatively

  24. NRS during stair-climbing

    Numeric Rating Scale of Pain During Stair-Climbing

    Measured: 2 years postoperatively

  25. NRS during performing sports

    Numeric Rating Scale of Pain During Sports

    Measured: pre-operatively

  26. NRS during performing sports

    Numeric Rating Scale of Pain During Sports

    Measured: 3 months post-operatively

  27. NRS during performing sports

    Numeric Rating Scale of Pain During Sports

    Measured: 1 year post-operatively

  28. NRS during performing sports

    Numeric Rating Scale of Pain During Sports

    Measured: 2 years post-operatively

  29. NRS during weight-bearing

    Numeric Rating Scale of Pain During Weightbearing

    Measured: pre-operatively

  30. NRS during weight-bearing

    Numeric Rating Scale of Pain During Weightbearing

    Measured: 3 months postoperatively

  31. NRS during weight-bearing

    Numeric Rating Scale of Pain During Weightbearing

    Measured: 1 year post-operativley

  32. FAAM

    Foot and Ankle Ability Measure

    Measured: pre-operatively

  33. FAAM

    Foot and Ankle Ability Measure

    Measured: 3 months postoperatively

  34. FAAM

    Foot and Ankle Ability Measure

    Measured: 1 year postoperatively

  35. FAAM

    Foot and Ankle Ability Measure

    Measured: 2 years postoperatively

  36. SF-12

    Short-Form 12

    Measured: pre-operatively

  37. SF-12

    Short-Form 12

    Measured: 3 months postoperatively

  38. SF-12

    Measured: 1 year postoperatively

  39. SF-12

    Short-Form 12

    Measured: 2 years postoperatively

  40. Ankle Activity Scale (AAS)

    Measured: pre-operatively

  41. Ankle Activity Scale (AAS)

    Measured: 3 months postoperatively

  42. Ankle Activity Scale (AAS)

    Measured: 1 year post-operatively

  43. Ankle Activity Scale (AAS)

    Measured: 2 year post-operatively

  44. Return to sports

    Measured: post-operatively until 2 years of follow-up post-operatively

  45. Return to work

    Measured: post-operatively until 2 years of follow-up post-operatively

  46. Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)

    Measured: pre-operatively

  47. Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)

    Measured: 2 weeks postoperatively

  48. Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)

    Measured: 1 year postoperatively

  49. Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)

    Measured: 2 years postoperatively

  50. Radiological outcomes: MRI scan (T2 relaxation times)

    Measured: Pre-operatively

  51. Radiological outcomes: MRI scan (T2 relaxation times)

    Measured: 1 year post-operatively

  52. Radiological outcomes: MRI scan (T2 relaxation times)

    Measured: 2 years post-operatively

  53. 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)

  54. Cell-subset analysis

    protein analyses will be performed by Sanquin

    Measured: per-operatively

  55. Demographic data

    all kinds of demographic data will be assessed (age, gender, etc.)

    Measured: Pre-operatively

  56. Complications

    all types of complications

    Measured: From per-operatively to post-operatively at 2 years (one period)

  57. 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.

  1. First posted17 Jul 2020
  2. Study start1 Sep 2020 (estimated)
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion2 Sep 2024 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT04475341.

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.

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