Osteochondral lesions under 15mm2 of the Talus; is iliac crest Bone marrow Aspirate Concentrate the Key to success?

Conditions: cartilage damage of the ankle
osteochondral talar defect
10005944

Registration Number: NL-OMON49126

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 72

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
• 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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the difference in pain during weight-bearing<br /><br>between pre-operative and 24 months after surgery on a numeric rating scale<br /><br>(NRS). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Secondary parameters are:<br /><br><br /><br>- Questionnaires: EQ5D, AOFAS, FAOS, NRS (in rest, during running, during<br /><br>stair-climbing, during performing sports), FAAM, SF-12, Ankle Activity Scale<br /><br>(AAS), return to sports, return to work<br /><br>- Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)<br /><br>and MRI scan (T2 relaxation times)<br /><br>- Cost-effectiviness<br /><br>- Cell-subset analysis<br /><br>- Complications, Re-operations, Demographic data</p><br>