We report the protocol of a prospective observational study on surgical and conservative therapies for painful thumb carpometacarpal (CMC) osteoarthritis.
150 consecutive patients who are referred to our centers for surgery or LD-EBRT of CMC arthrosis will be offered the participation in this trial.
Four examinations are planned: 1) baseline (after given informed consent, before treatment), 2) at three months, 3) at 12 months, and 4) at 24 months after therapy.
Primary endpoint is symptom reduction by means of amelioration of pain (measured by visual analogue scale), improvement of motion (active range of motion, Kapandji-index), changes in grip strength (Jamar dynamometer, Pinch Gauge Meter), and subjective response to therapy (no change, partial remission, complete remission). Secondary endpoints are changes in Quality of Life measured by standardized questionnaires (DASH, PRWE). Further endpoints are the incidences of complications after therapy.
The aims of the proposed study are:
1) to provide evidence on the effi cacy of LD-EBRT regarding pain reduction, of function, and of the quality of life after short- (3 months) and long-term (one and two years) follow-up. To our knowledge, this
has never been done before.
2) to compare these results with the same endpoints in patients treated with surgery.
Published on: Dec 6, 2016 Pages: 15-17