No registrations found.
Source
Brief title
Health condition
Hallux Valgus
IMA
HVA
Bununion
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Inter-metatarsal angle (IMA).
Secondary outcome
1. Radiographic evaluation of the articular angles;
HVA;
2. Perceived disability as quantified by the following scoring system:
A. SF-36;
B. FAOS;
C. Range of motion.
3. Patient overall satisfaction with the outcome of the treatment on a VAS;
4. Adverse events.
Background summary
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.
Study objective
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.
Study design
1. 6 weeks;
2. 3 months;
3. 12 months.
Intervention
1. Chevron osteotomy;
2. Scarf osteotomy.
Louwesweg 6<br>
Postbus 9440
D. Haverkamp
Amsterdam 1006 BK
The Netherlands
daniel.haverkamp@slz.nl
Louwesweg 6<br>
Postbus 9440
D. Haverkamp
Amsterdam 1006 BK
The Netherlands
daniel.haverkamp@slz.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3708 |
NTR-old | NTR3906 |
CCMO | NL42886.04.8.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |