Our primary objective is to compare the short term (3 months) clinical and radiographic results of the Bledsoe Thruster with the SofTec OA Brace in the management of patients with medial knee OA and a varus leg alignment.
ID
Bron
Aandoening
Valgus bracing, unicompartmental osteoarhritis, varus knee, RCT
Ondersteuning
B&Co INC NV (Bledsoe Thruster Brace), Mutsaardstraat 47, 9550 Herzele, Belgium
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Difference in the VAS pain score at 3 months between the Bledsoe Thruster group and the SofTec OA Brace group.
Achtergrond van het onderzoek
Background of the study:
Knee osteoarthritis (OA) is one of the most common joint disorders and is a major cause of knee pain and immobility. Treatment can be non-operative or operative. Operative treatment is not suitable for every patient, because of medical comorbidity, old age or other circumstances. In young patients it is desirable to delay primary arthroplasty. Osteoarthritis of the knee is more located in the medial compartment. Patients with OA of the medial compartment also often have a varus alignment and the varus deformity causes an overlaoad of the medial compartment with increasing symptoms during weight bearing. malalignment increases risk for progression of knee OA. Valgus braces are designed to unlaod the medial compartment in order to decrease pain and improve function. Recent systematic reviews concluded that there is very limited evidence for the effectiveness of brace treatment for medial knee osteoarthritis, mainly because of lack of randomized clinical trials. More than 30 commercially available braces are produced nowadays, with al kind of different brace designs. To our knowledge no study has compared the effectiveness of two different kind of braces as treatment of medial knee OA in a randomized clinical trial.
Doel van het onderzoek
Our primary objective is to compare the short term (3 months) clinical and radiographic results of the Bledsoe Thruster with the SofTec OA Brace in the management of patients with medial knee OA and a varus leg alignment.
Onderzoeksopzet
Baseline, 2 weeks and 3 months.
Onderzoeksproduct en/of interventie
Trial arm 1: 3 months prescription of the Bledsoe Thruster Brace.
Trial arm 2: 3 months prescription of the SofTec OA Brace.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with medial knee osteoarthritis (confirmed on x-ray (AP and lateral) using the Kellgren classification);
2. Medial knee pain;
3. Varus leg alignment (confirmed on X-ray);
4. Age between 18-70.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Insufficient command of the Dutch language;
2. The inability to apply brace because of physical or cognitive limitations;
3. Symptomatic back/hip/ankle/foot pathology (which makes improvement of pain, function, quality of life and satisfaction, by wearing a brace, impossible);
4. Other than osteoarthritis causing knee pain (like arthritis);
5. Pre-existing skin problems.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2322 |
NTR-old | NTR2428 |
Ander register | CCMO : 2010/200 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |