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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49126
Enrollment
72
Registered
2020-10-20
Start date
2020-09-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cartilage damage of the ankle

Interventions

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 mar

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients with a symptomatic OCL of the talus who are scheduled for arthroscopic debridement and microfracture • OCL depth and/or diameter

Exclusion criteria

Exclusion criteria: • Concomitant OCL of the tibia • Ankle osteoarthritis grade 2 or 3 • Ankle fracture

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the difference in pain during weight-bearing between pre-operative and 24 months after surgery on a numeric rating scale (NRS).

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)