Chevron osteotomy for the treatment of hallux valgus - Effectiveness of postoperative immobilisation by a plaster cast or walking boot

Chevron osteotomy for the treatment of hallux valgus - Effectiveness of postoperative immobilisation by a plaster cast or walking boot - Chevron osteotomy: immobilisation by cast or walking boot?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38594

Enrollment

100

Registered

2013-12-05

Start date

2015-08-09

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

deformity of the big toe hallux valgus

Interventions

The type of postoperative immobilisation will be determined by means of randomisation. The anesthetic and pain protocols will be standardized. Discharge criteria will also be the same in both study

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - at least 18 years old; - mild symptomatic hallux valgus: intermetatarsal 1 and 2 angle (IMA) of

Exclusion criteria

Exclusion criteria: Patients with: - Diabetes mellitus; - Rheumatoid arthritis; - Predison use.

Design outcomes

Primary

Measure	Time frame
Primary study parameter is the proportion patients with a loss of more than 5 degrees of the correction of the hallux valgus angle (HVA), one year following surgery. The HVA is measured at standard weigtbearing X-rays of the foot by means of a reliable measurement protocol. These X-rays are part of the standard clinical follow-up after Chevron osteotomy. They are made preoperatively, and one day, 6 weeks, 6 and 12 months postoperatively. A loss of more than 5 degrees of the correction of the hallux valgus angle is considered a clinically relevant loss.	—

Measure

Time frame

Primary study parameter is the proportion patients with a loss of more than 5 degrees of the correction of the hallux valgus angle (HVA), one year following surgery. The HVA is measured at standard weigtbearing X-rays of the foot by means of a reliable measurement protocol. These X-rays are part of the standard clinical follow-up after Chevron osteotomy. They are made preoperatively, and one day, 6 weeks, 6 and 12 months postoperatively. A loss of more than 5 degrees of the correction of the hallux valgus angle is considered a clinically relevant loss.

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Secondary

Measure	Time frame
- Difference in (the course of regression of the) HVA and Intermetatarsal 1 and 2 angle (IMA) - Plantar pressure: - peak pressure of eight regions of the forefoot Plantar pressure during walking will be assessed preoperatively and 3, 6 and 12 months postoperatively. Since the postoperative immobilisation will take 6 weeks, the first postoperative measurement will take place at 3 months following surgery. Plantar pressure will be measured by means of insoles which contain pressure sensors, the Pedar Insole system® (Novel, München, Duitsland). The Pedar Insole system is a wireless system, containing insoles that are connected to a data-receiver that is carried on the waist. To exclude variation in results because of differences in shoes, standardizes shoes will be used for the measurements. - Physical functioning - Health-related quality of life. Physical functioning and health-related quality of life will be assessed by means of questionnaires. These questionnaires will be assessed preoperatively, and 6 weeks, 3, 6 and 12 months postoperatively. Physical functioning will be measured by means of the Foot Function Index (FFI). The FFI consists of 23 items, divided into 3 subscales. Health-related quality of life will be measured by means of the EQ-5D, consisting of 5 questions.	—

Measure

Time frame

- Difference in (the course of regression of the) HVA and Intermetatarsal 1 and 2 angle (IMA) - Plantar pressure: - peak pressure of eight regions of the forefoot Plantar pressure during walking will be assessed preoperatively and 3, 6 and 12 months postoperatively. Since the postoperative immobilisation will take 6 weeks, the first postoperative measurement will take place at 3 months following surgery. Plantar pressure will be measured by means of insoles which contain pressure sensors, the Pedar Insole system® (Novel, München, Duitsland). The Pedar Insole system is a wireless system, containing insoles that are connected to a data-receiver that is carried on the waist. To exclude variation in results because of differences in shoes, standardizes shoes will be used for the measurements. - Physical functioning - Health-related quality of life. Physical functioning and health-related quality of life will be assessed by means of questionnaires. These questionnaires will be assessed preoperatively, and 6 weeks, 3, 6 and 12 months postoperatively. Physical functioning will be measured by means of the Foot Function Index (FFI). The FFI consists of 23 items, divided into 3 subscales. Health-related quality of life will be measured by means of the EQ-5D, consisting of 5 questions.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)