To identify if the modified chevron is a non-inferior operation technique than the scarf osteotomy for the correction of IMA and HVA and if it results in a better function and lower complication rates.
Bron
Verkorte titel
Aandoening
Hallux Valgus
IMA
HVA
Bununion
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
Inter-metatarsal angle (IMA).
Achtergrond van het onderzoek
Hallux valgus (HV) can have a great impact on the quality of life and is a frequent occurring condition. Many surgical techniques have been described to treat HV in order to improve the quality of life, over the years more than 100 different techniques or modifications are coined. In the current era the most popular and effective are the scarf osteotomy and the (modified) Chevron technique. The scarf osteotomy is popular because of its capability of correcting large IMA’s, however this procedure has some disadvantages. It is characterise by an extensive operative exposure and great technical demands. The modified Chevron osteotomy in which the caudal osteotomy is longer, has also been shown to be capable of correcting severe hallux valgus deformities. The indications for the modified chevron- and the scarf osteotomy certainly overlap, the question remains if the technically easier, more reproducible modified Chevron reaches the same result as a more difficult scarf osteotomy. By conducting this research we might be able to identify, if the modified chevron is a non-inferior operation technique than the scarf osteotomy for the correction of IMA and if it results in a lower complication rate.
Doel van het onderzoek
To identify if the modified chevron is a non-inferior operation technique than the scarf osteotomy for the correction of IMA and HVA and if it results in a better function and lower complication rates.
Onderzoeksopzet
1. 6 weeks;
2. 3 months;
3. 12 months.
Onderzoeksproduct en/of interventie
1. Chevron osteotomy;
2. Scarf osteotomy.
Publiek
Louwesweg 6<br>
Postbus 9440
D. Haverkamp
Amsterdam 1006 BK
The Netherlands
daniel.haverkamp@slz.nl
Wetenschappelijk
Louwesweg 6<br>
Postbus 9440
D. Haverkamp
Amsterdam 1006 BK
The Netherlands
daniel.haverkamp@slz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. All patients between 18 - 75 years of age with a hallux valgus;
2. No radiographic evidence of degenerative metatarsophalangeal MTPJ arthritis;
3. Persistent symptoms (painful bunion);
4. Adequate range of motion;
5. IMA 10-20 degrees;
6. Stable TMT 1;
7. Normal hindfoot alignment.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients younger than 18 years of age;
2. Severe osteoporosis;
3. Cognitive dysfunction limiting clinical evaluation;
4. Previous operation on the affected foot;
5. History of diabetes, peripheral vascular disease, peripheral neuropathy, rheumatoid arthritis, or other inflammatory diseases.
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 | NL3708 |
NTR-old | NTR3906 |
CCMO | NL42886.04.8.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |