Standsafwijking arthrosis Unicompartimental osteoarthritis
Conditions
Interventions
According to a randomization scheme, the osteotomy gap will be filled with
either the synthetic ceramic material AttraX® Putty or without a gap filler
(conventional method).
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients above 18 years with an indication for an open-wedge osteotomy of the femur, tibia or double level due to unicompartimental OA. 2. Comply with all aspects of the treatment, including CT scans, Xrays and 1-year follow-up 3. Informed consent
Exclusion criteria
Exclusion criteria: 1. Osteotomy for indication of cartilage treatment or other knee surgeries than unicompartimental OA 2. Correction using an open wedge above 10 mm 3. Pregnant women at the time of enrolment or women who are planning to become pregnant during the duration of the study 4. Inability to communicate in Dutch or English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the mean NRS pain during the first week postoperative. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study endpoints are faster accelerated rehabilitation/regaining function, reduction of local blood loss, accelerated, bone union, and comparable surgical feasibility | — |
Countries
Netherlands
Outcome results
None listed