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van CCT (UK)


Inlay versus brace treatment for medial knee osteoarthritis. A randomised trial.


- candidate number1693
- NTR NumberNTR484
- ISRCTNISRCTN92527149
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDs
- Public TitleInlay versus brace treatment for medial knee osteoarthritis. A randomised trial.
- Scientific TitleLateral wedge sole versus knee brace in the treatment of unicompartmental knee osteoarthritis. A randomised trial.
- ACRONYMSOLE
- hypothesisAn inlay for the treatment of medial knee osteoarthritis will result in pain reduction, function improvement and better compliance then brace treatment.
- Healt Condition(s) or Problem(s) studiedArthritis, Osteoarthritis
- Inclusion criteriaPatients (male and female) with symptomatic medial osteoarthritis of the knee are included. Patients will be included after informed consent given and baseline measurements made.
- Exclusion criteriaExclusion criteria are below 35 or above 60 years of age, symptoms not related to medial osteoarthritis of the knee or not able to speak or understand Dutch.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2005
- planned closingdate31-dec-2007
- Target number of participants100
- InterventionsGroup I: laterale wedge sole (inlay);
Group II: valgisation knee brace (brace).
- Primary outcomeWill inlay treatment for patients with symptomatic medial knee ostearthritis yield better results then brace treatment?

Measurements:
1. Painscore (VAS);
2. Hospital for Special Surgery (HHS) Knee Service Rating System;
3. Western Ontario and McMaster University Osteoarthritis Index (WOMAC).
- Secondary outcomeI- Will there be a functional diference between both groups?

Measurements:
1. Gait analysis (knee adduction moment, toeing-out, knee extension moment);
2. Knee range of motion;
3. Patient satisfaction;
4. Maxmium walking distance
II Will conservative treatment (inlay or brace) give a favourable outcome for medial knee osteoarthritis?

Measurements:
5. Dual energy x-ray absorptiometry (DEXA-scan);
6. Osteoarthritis markers (serum and urine);
7. Hip-knee-ankel (HKA)angle.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPhD T.M. Raaij, van
- CONTACT for SCIENTIFIC QUERIESPhD T.M. Raaij, van
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Stichting Anna Fonds, Erasmus Medical Center - Stichting Algesiologie
- PublicationsBraces and orthoses for treating osteoarthritis of the knee.
Brouwer RW, Jakma TS, Verhagen AP, Verhaar JA, Bierma-Zeinstra SM.
Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004020.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD19-sep-2005 - 1-feb-2010


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