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Is there a difference in outcome between PIP- resection- arthroplasty and PIP- arthrodesis in correcting symptomatic claw toes?


- candidate number4299
- NTR NumberNTR1511
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2008
- Secondary IDs07.0219 
- Public TitleIs there a difference in outcome between PIP- resection- arthroplasty and PIP- arthrodesis in correcting symptomatic claw toes?
- Scientific TitleIs there a difference in outcome between PIP- resection- arthroplasty and PIP- arthrodesis in correcting symptomatic claw toes?
- ACRONYMN/A
- hypothesisPatients with symptomatic rigid claw toes have better postoperative outcome after PIP- resection arthroplasty, compared to PIP- arthrodesis.
- Healt Condition(s) or Problem(s) studiedArthroplasty , Arthrodesis, Claw toes, Proximal interphalangeal (PIP)
- Inclusion criteria- Every patient, between 20 and 85 years old, with symptomatic rigid claw toes, with an indication for surgical intervention; after failure of conservative therapy. The PIP joint needs to be rigid.
- Exclusion criteria1. Previous surgical interventions of toes/ forefoot (except for hallux)
2. Simultaneous surgical intervention of the foot, except for toe surgery
3. Specific comorbidity: arterial insufficiency, Complex Regional Pain Syndrome, diabetes mellitus, neuropathy, ongoing infectie, HMSN, congenital disorders, SLE
- General joint impairment (ie. reumato´d arthritis, poly-arthritis)
- Pre-existent limited mobility as result of different pathology (ie. hemiplegia, amputation)
- 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
- InterventionsCorrection of the proximal interphalangeal joint (PIP) with two different surgical methods:

1. PIP- arthrodesis
2. PIP- resection- arthroplasty
- Primary outcome- Foot function, graded by a validated out come tool: AOFAS score
- Secondary outcome- Foot Function Index
- Mobility
- Physical examination
- SF-36
- Vas pain score
- Timepoints- Preoperative - 2 weeks postop
- 6 weeks postop
- 3 months postop
- 1 year postop
- 5 years postop
- Trial web siteN/A
- statusplanned
- 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, Sint Maartenskliniek Nijmegen
- PublicationsN/A
- Brief summaryThe primary goal of this study is evaluating which surgical procedure in correcting rigid claw toes has best outcome; comparing PIP- desis vs PIP- resection arthroplasty.
Study design: RCT, multicentre
Study population: 100 patients
Follow up: 5 years
- Main changes (audit trail)
- RECORD28-okt-2008 - 14-nov-2008


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