Osteochondral Lesions Under 15mm2 of the Talus; is Iliac Crest Bone Marrow Aspirate Concentrate the Key to Success?
- Conditions
- Osteochondral Lesion of Talus
- Interventions
- Procedure: BMS aloneBiological: BMS + Bone Marrow Aspirate Concentrate
- Registration Number
- NCT04475341
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS without BMAC BMS alone - BMS with BMAC BMS + Bone Marrow Aspirate Concentrate -
- Primary Outcome Measures
Name Time Method Numeric Rating Scale of Pain During Weightbearing 2 years post-operatively
- Secondary Outcome Measures
Name Time Method FAOS two years post-operatively Foot and Ankle Outcome Score
NRS in rest 2 years postoperatively Numeric Rating Scale of Pain During Rest
EQ5D two years post-operatively AOFAS two years post-operatively American Orthopaedic Foot and Ankle Score (AOFAS)
FAAM 2 years postoperatively Foot and Ankle Ability Measure
SF-12 2 years postoperatively Short-Form 12
NRS during running 2 years postoperatively Numeric Rating Scale of Pain During Running
NRS during stair-climbing 2 years postoperatively Numeric Rating Scale of Pain During Stair-Climbing
NRS during performing sports 2 years post-operatively Numeric Rating Scale of Pain During Sports
NRS during weight-bearing 1 year post-operativley Numeric Rating Scale of Pain During Weightbearing
Ankle Activity Scale (AAS) 2 year post-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) 2 years postoperatively 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
Radiological outcomes: MRI scan (T2 relaxation times) 2 years post-operatively