Patients with symptomatic rigid claw toes have better postoperative outcome after PIP- resection arthroplasty, compared to PIP- arthrodesis.
ID
Bron
Verkorte titel
Aandoening
General population with symptomatic rigid claw toes
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Foot function, graded by a validated out come tool: AOFAS score
Achtergrond van het onderzoek
The 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
Doel van het onderzoek
Patients with symptomatic rigid claw toes have better postoperative outcome after PIP- resection arthroplasty, compared to PIP- arthrodesis.
Onderzoeksopzet
- Preoperative
- 2 weeks postop
- 6 weeks postop
- 3 months postop
- 1 year postop
- 5 years postop
Onderzoeksproduct en/of interventie
Correction of the proximal interphalangeal joint (PIP) with two different surgical methods:
1. PIP- arthrodesis
2. PIP- resection- arthroplasty
Publiek
Da Costastraat 57-II
Amsterdam 1053 ZE
The Netherlands
+31 (0)6 18515625
Wetenschappelijk
Da Costastraat 57-II
Amsterdam 1053 ZE
The Netherlands
+31 (0)6 18515625
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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. reumatoïd arthritis, poly-arthritis)
- Pre-existent limited mobility as result of different pathology (ie. hemiplegia, amputation)
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 | NL1450 |
| NTR-old | NTR1511 |
| Ander register | : 07.0219 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |