Clinical trial NCT04475341: Osteochondral Lesions Under 15mm2 of the Talus; is Iliac Crest Bone Marrow Aspirate Concentrate the Key to Success?
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'
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteochondral Lesion of Talus
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Numeric Rating Scale of Pain During Weightbearing
timeFrame: 2 years post-operatively
Secondary outcomes:
measure: EQ5D
timeFrame: pre-operatively
measure: EQ5D
timeFrame: three months postoperatively
measure: EQ5D
timeFrame: one-year post-operatively
measure: EQ5D
timeFrame: two years post-operatively
measure: AOFAS
timeFrame: preoperatively
measure: AOFAS
timeFrame: three months postoperatively
measure: AOFAS
timeFrame: one-year post-operatively
measure: AOFAS
timeFrame: two years post-operatively
measure: FAOS
timeFrame: pre-operatively
measure: FAOS
timeFrame: three months
measure: FAOS
timeFrame: one-year post-operatively
measure: FAOS
timeFrame: two years post-operatively
measure: NRS in rest
timeFrame: pre-operatively
measure: NRS in rest
timeFrame: 3 months postoperatively
measure: NRS in rest
timeFrame: 1 year postoperatively
measure: NRS in rest
timeFrame: 2 years postoperatively
measure: NRS during running
timeFrame: pre-operatively
measure: NRS during running
timeFrame: 3 months postoperatively
measure: NRS during running
timeFrame: 1 year postoperatively
measure: NRS during running
timeFrame: 2 years postoperatively
measure: NRS during stair-climbing
timeFrame: pre-operatively
measure: NRS during stair-climbing
timeFrame: 3 months postoperatively
measure: NRS during stair-climbing
timeFrame: 1 year postoperatively
measure: NRS during stair-climbing
timeFrame: 2 years postoperatively
measure: NRS during performing sports
timeFrame: pre-operatively
measure: NRS during performing sports
timeFrame: 3 months post-operatively
measure: NRS during performing sports
timeFrame: 1 year post-operatively
measure: NRS during performing sports
timeFrame: 2 years post-operatively
measure: NRS during weight-bearing
timeFrame: pre-operatively
measure: NRS during weight-bearing
timeFrame: 3 months postoperatively
measure: NRS during weight-bearing
timeFrame: 1 year post-operativley
measure: FAAM
timeFrame: pre-operatively
measure: FAAM
timeFrame: 3 months postoperatively
measure: FAAM
timeFrame: 1 year postoperatively
measure: FAAM
timeFrame: 2 years postoperatively
measure: SF-12
timeFrame: pre-operatively
measure: SF-12
timeFrame: 3 months postoperatively
measure: SF-12
timeFrame: 1 year postoperatively
measure: SF-12
timeFrame: 2 years postoperatively
measure: Ankle Activity Scale (AAS)
timeFrame: pre-operatively
measure: Ankle Activity Scale (AAS)
timeFrame: 3 months postoperatively
measure: Ankle Activity Scale (AAS)
timeFrame: 1 year post-operatively
measure: Ankle Activity Scale (AAS)
timeFrame: 2 year post-operatively
measure: Return to sports
timeFrame: post-operatively until 2 years of follow-up post-operatively
measure: Return to work
timeFrame: post-operatively until 2 years of follow-up post-operatively
measure: Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
timeFrame: pre-operatively
measure: Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
timeFrame: 2 weeks postoperatively
measure: Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
timeFrame: 1 year postoperatively
measure: Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
timeFrame: 2 years postoperatively
measure: Radiological outcomes: MRI scan (T2 relaxation times)
timeFrame: Pre-operatively
measure: Radiological outcomes: MRI scan (T2 relaxation times)
timeFrame: 1 year post-operatively
measure: Radiological outcomes: MRI scan (T2 relaxation times)
timeFrame: 2 years post-operatively
measure: Cost-effectiviness
timeFrame: From per-operatively to post-operatively at 2 years (one period)
measure: Cell-subset analysis
timeFrame: per-operatively
measure: Demographic data
timeFrame: Pre-operatively
measure: Complications
timeFrame: From per-operatively to post-operatively at 2 years (one period)
measure: Re-operations
timeFrame: From per-operatively to post-operatively at 2 years (one period)
Other outcomes:
Locations:
Study officials:
References: