A comparison of fusion versus half joint replacement for arthritis of the big toe joint
Completed
- Conditions
- Hallux rigidus (osteoarthritis of the first metatarsophalgeal joint)Musculoskeletal DiseasesPrimary arthrosis of other joints
- Registration Number
- ISRCTN88273654
- Lead Sponsor
- East Lancashire Hospitals NHS Trust (UK)
- Brief Summary
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24625034
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1. Coughlin grade 3-4 hallux rigidus with near constant pain and stiffness at least at extremes of passive motion +/- mid range of motion pain, in whom conservative treatment measures have failed
2. Able to give informed consent
3. Male or female
4. Aged 45 years or above
Exclusion Criteria
1. Inflammatory Arthritis
2. Active Infection
3. Severe vascular or neurological deficit affecting the lower limbs
4. Hallux Valgus angle greater than 15 degrees
5. Inadequate or poor quality bone stock
6. Any previous surgery to the 1st MPTJ other than a cheilectomy
7. Significant and symptomatic interphalangeal joint or sesamoid-metatarsal osteoarthritis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Manchester - Oxford Foot Questionnaire (MOX-FQ) - measured at baseline then at 6 weeks, 3 months and 12 months post-operatively.
- Secondary Outcome Measures
Name Time Method <br> 1. EuroQol (EQ-5D)<br> 2. Pain visual analogue scale (0=no pain, 10=unbearable pain)<br> 3. American Orthopaedic Foot & Ankle Society Hallux score (AOFAS-Hallux)<br> 4. Hospital length of stay<br> 5. Return to work<br> 6. Complication rate<br> 7. Re-operation rate (failed procedure, removal of metalwork)<br>