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Is there a difference in outcome between the Hoffman procedure and MTP-soft tissue-release in correcting reumatoid MTP-deformities?


- candidate number4295
- NTR NumberNTR1520
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-okt-2008
- Secondary IDs07 .0220
- Public TitleIs there a difference in outcome between the Hoffman procedure and MTP-soft tissue-release in correcting reumatoid MTP-deformities?
- Scientific TitleSame as above
- ACRONYMN/A
- hypothesisMTP-soft tissue- release has a better outcome in correcting reumatoid MTP- deformities, compared to the Hoffman procedure
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Joint, Hoffman procedure, Metatarsophalangeal
- Inclusion criteriaEvery patient suffering reumatoid arthritis, between 20 and 85 years old, with symptomatic MTP- deformities, as defined, with an indication for surgical intervention, not responding on conservative treatment during at least 6 months.
- Exclusion criteria1. Previous surigical intervention of toes
2. Infected bursae/ clavi
3. Active reumatoid arthritis
4. Simultaneous foot surgery; except for toe surgery
5. Specific comorbidity: insufficienty of arterial system, complex regional pain syndrome, diabetes mellitus, ongoing infection
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2008
- planned closingdate1-nov-2013
- Target number of participants100
- InterventionsTwo surgical procedures regarding the metatarsophalangeal joints in reumatic foot disorders:
1. Hoffman procedure
2. MTP- soft tissue release
- Primary outcomeAOFAS-score (validated foot function score)
- Secondary outcome- Foot function index
- SF-36
- Complications
- VAS pain score
- Mobility score
- X-ray of foot
- Timepoints- Preoperative
- 2 weeks postoperative
- 6 weeks postoperative
- 3 months postoperative
- 1 and 5 years postoperative
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J.C.M. Schrier
- CONTACT for SCIENTIFIC QUERIES J.C.M. Schrier
- Sponsor/Initiator Isala klinieken, Locatie Sophia, Sint Maartenskliniek Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Isala Klinieken
- Publications- Opinions on lesser toe deformities among Dutch orthopaedic departments.Foot Ankle Int. 2007 Dec;28(12):1265-70. Schrier JC, Louwerens JW, Verheyen CC.
- The definitions of lesser toe deformities in literature. JAPMA, ahead of publication. Schrier JC, Louwerens JW, Verheyen CC.
- Brief summaryThe goal of this RCT is identifying the best surgical method in reumatoid forefoot deformities, comparing the Hoffman procedure and MTP soft tissue- release. It is a multi centre study, involving 5 hospitals, with a follow up of 5 years.
- Main changes (audit trail)
- RECORD27-okt-2008 - 14-nov-2008


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