Osteochondral Lesion of Talus
Conditions
Brief 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. 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.
Interventions
BIOLOGICALBMS + Bone Marrow Aspirate Concentrate
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.
PROCEDUREBMS alone
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.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale of Pain During Weightbearing | 2 years post-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AOFAS | preoperatively | American Orthopaedic Foot and Ankle Score (AOFAS) |
| FAOS | pre-operatively | Foot and Ankle Outcome Score |
| NRS in rest | pre-operatively | Numeric Rating Scale of Pain During Rest |
| NRS during running | pre-operatively | Numeric Rating Scale of Pain During Running |
| NRS during stair-climbing | pre-operatively | Numeric Rating Scale of Pain During Stair-Climbing |
| NRS during performing sports | pre-operatively | Numeric Rating Scale of Pain During Sports |
| NRS during weight-bearing | pre-operatively | Numeric Rating Scale of Pain During Weightbearing |
| FAAM | pre-operatively | Foot and Ankle Ability Measure |
| SF-12 | pre-operatively | Short-Form 12 |
| EQ5D | pre-operatively | — |
| Return to sports | post-operatively until 2 years of follow-up post-operatively | — |
| Return to work | post-operatively until 2 years of follow-up post-operatively | — |
| Radiological outcomes: CT-scan (depth, wide, length, joint space measurement) | pre-operatively | — |
| Radiological outcomes: MRI scan (T2 relaxation times) | Pre-operatively | — |
| Cost-effectiviness | From per-operatively to post-operatively at 2 years (one period) | all relevant clinical costs will be scored through a patient diary |
| Cell-subset analysis | per-operatively | protein analyses will be performed by Sanquin |
| Demographic data | Pre-operatively | all kinds of demographic data will be assessed (age, gender, etc.) |
| Complications | From per-operatively to post-operatively at 2 years (one period) | all types of complications |
| Re-operations | From per-operatively to post-operatively at 2 years (one period) | re-operations will be assessed |
| Ankle Activity Scale (AAS) | pre-operatively | — |
Contacts
Primary ContactJari Dahmen, MD, BSc
Outcome results
None listed