Hallux Rigidus Minimally invasive Trial comparing minimally invasive cheilectomy of the great toe metatarsophalangeal joint with open cheilectomy

Minimally invasive vs open cheilectomy: A single-blinded randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91428492

Enrollment

Registered

2012-04-18

Start date

2012-03-10

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

First metatarsophalangeal joint arthritis Musculoskeletal Diseases Other arthrosis

Interventions

Patients randomised to minimally invasive or open cheilectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients over the age of 18 and under the age of 90 2. Patients undergoing primary surgery 3. Patients who are able to give informed consent to the trial

Exclusion criteria

Exclusion criteria: 1. Patients less than the age of 18 and over the age of 90 2. Patients who are not undergoing primary surgery 3. Lack of capacity to give informed consent

Design outcomes

Primary

Measure	Time frame
The American Orthopaedic Foot & Ankle Society (AOFAS) hallux metatarsophalangeal-interphalangeal scale is a validated and widely used tool for assessing forefoot function. The score rates first metatarsophalangeal / interphalangeal function out of 100 points where 100 is the best possible score. Measured pre-op, 6 weeks, 3 months, 6 months and 1 year post-surgery.	—

Secondary

Measure	Time frame
1. Manchester Oxford Foot Questionnaire (MOXFQ) (3). This is a relatively new patient-based questionnaire which has been evaluated in the context of hallux valgus surgery and previously used to assess the outcome of cheilectomy. The score consists of three domains [Pain (7 questions), Walking (4 questions) and Social interaction (4 questions)] and is assessed using a structured questionnaire with the results are expressed as a metric value between 0 and 100 2. Time to return to normal shoes 3. Time to return to employment 4. Visual analogue pain scores 5. Re-operation rate Measured pre-op, 6 weeks, 3 months, 6 months and 1 year post-surgery. Patients will also complete a pain diary for 14 days after surgery.	—

Measure

Time frame

1. Manchester Oxford Foot Questionnaire (MOXFQ) (3). This is a relatively new patient-based questionnaire which has been evaluated in the context of hallux valgus surgery and previously used to assess the outcome of cheilectomy. The score consists of three domains [Pain (7 questions), Walking (4 questions) and Social interaction (4 questions)] and is assessed using a structured questionnaire with the results are expressed as a metric value between 0 and 100 2. Time to return to normal shoes 3. Time to return to employment 4. Visual analogue pain scores 5. Re-operation rate Measured pre-op, 6 weeks, 3 months, 6 months and 1 year post-surgery. Patients will also complete a pain diary for 14 days after surgery.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026