The effect of postoperative physiotherapy, after Chevron osteotomy, on foot function. A randomized controlled trial.
|- candidate number||10095|
|- NTR Number||NTR2978|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jul-2011|
|- Secondary IDs||11.0786 METC|
|- Public Title||The effect of postoperative physiotherapy, after Chevron osteotomy, on foot function. A randomized controlled trial.
|- Scientific Title||The effect of postoperative physiotherapy, after Chevron osteotomy, on foot function. A randomized controlled trial.
|- hypothesis||Postoperative physiotherapy, after Chevron osteotomy, will promote the function of the first MTP joint, as expressed by a difference in AOFAS hallux score of 10 points, compared to a study group without postoperative physiotherapy, after a six months period of follow-up. |
|- Healt Condition(s) or Problem(s) studied||Physiotherapy, Treatment outcome, Hallux valgus, Surgical correction, Chevron osteotomy, Foot function|
|- Inclusion criteria||1. Patients with an indication for Chevron osteotomy: Intractable pain isolated to the first or second MTP joint region, associated with a hallux valgus deformity, refractory to conservative treatment (shoe modifications, NSAIDs, modification of activities), with following rontgenographic details: Intermetatarsal Angle ≤ 20o;|
2. Age 18-65;
3. Physiologic preoperative gait pattern.
|- Exclusion criteria||Specific comorbidity: Inflammatory arthritis, degenerative arthritis of the first MTP joint, previous foot surgery, rheumatoid arthritis, diabetes mellitus, peripheral vascular disease, neuropathy, neuromuscular disease, active infection, incompetent person.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2011|
|- planned closingdate||1-sep-2013|
|- Target number of participants||60|
|- Interventions||Postoperative physiotherapy, after surgical correction of a hallux valgus deformity, by a Chevron osteotomy.|
Two groups of patients will be compared. Both groups will be operated, with surgical correction of the hallux valgus. One group will undergo a standard postoperative treatment. The second group will receive additional physiotherapy, according to a standardized protocol.
|- Primary outcome||AOFAS Hallux score.|
|- Secondary outcome||1. Function of first MTP-joint: This will be measured by placing a hand-held goniometer parallel to the long axis of the first metatarsal and the hallux;|
2. Foot Function Index25;
3. VAS pain/satisfaction/ cosmesis.
|- Timepoints||Preoperative, 6 weeks, 3 months and 1 year postoperative.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| J.C.M. Schrier|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. C.C.P.M. Verheyen|
|- Sponsor/Initiator ||Isala Clinics Zwolle|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
Only a few studies, of poor quality and design, have focussed on the postoperative treatment after surgical hallux valgus correction. Conflicting results have been reported regarding postoperative foot function, after surgical correction of hallux valgus.
Evaluation of the effect of postoperative physiotherapy, after Chevron osteotomy, on foot function.
Randomized controlled trial in a single centre, with one year follow-up.
Patients with a symptomatic hallux valgus deformity, without effective conservative treatment, aged between 18 and 65.
Postoperative physiotherapy, consistent with our specific treatment protocol.
AOFAS Hallux score.
Burden and risks:
No risks, as result of inclusion in this study. Patients randomized to the physiotherapy group will undergo several sessions of physiotherapy. Both groups will be asked to fill out several questionnaires, during their visits to the outpatient clinic. This will lead to extra time. All other aspects pre and postoperatively are normal activities and efforts, as result of normal patient care, apart from the study.
|- Main changes (audit trail)|
|- RECORD||6-jul-2011 - 2-sep-2011|
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