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Scarf versus modified chevron osteotomy; A randomised controlled trial.


- candidate number14523
- NTR NumberNTR3906
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mrt-2013
- Secondary IDsNL42886.04.8.12 METC Slotervaart Hospital
- Public TitleScarf versus modified chevron osteotomy; A randomised controlled trial.
- Scientific TitleSurgical CorrecTion of the Intra MetataRsal Angle In Hallux Valgus, Modified Chevron versus Scarf OsTeotomy.
- ACRONYMSTRAIGHT-Trial
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedHallux valgus, Bununion
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2013
- planned closingdate1-mrt-2014
- Target number of participants40
- Interventions1. Chevron osteotomy;
2. Scarf osteotomy.
- Primary outcomeInter-metatarsal angle (IMA).
- Secondary outcome1. 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.
- Timepoints1. 6 weeks;
2. 3 months;
3. 12 months.
- Trial web sitewww.drhaverkamp.com/straight
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. D. Haverkamp
- CONTACT for SCIENTIFIC QUERIESDr. D. Haverkamp
- Sponsor/Initiator Slotervaart Hospital
- Funding
(Source(s) of Monetary or Material Support)
Stichting Klinisch Wetenschappelijk Onderzoek Slotervaartziekenhuis
- PublicationsN/A
- Brief summaryHallux 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.
- Main changes (audit trail)
- RECORD15-mrt-2013 - 1-apr-2013


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