Skip to content

A comparison of fusion versus "half joint" replacement for arthritis of the big toe joint

First metatarsophalangeal arthrodesis versus hemiarthroplasty for hallux rigidus: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88273654
Enrollment
30
Registered
2012-05-21
Start date
2012-10-01
Completion date
Unknown
Last updated
2018-12-10

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

Conditions

Hallux rigidus (osteoarthritis of the first metatarsophalgeal joint) Musculoskeletal Diseases Primary arthrosis of other joints

Interventions

1. Arthrodesis of the first metatarsophalgeal joint (active control group) 2. Proximal phalanx hemiarthroplasty (AnaToemic prosthesis, Arthrex Inc) Participants in bot

Sponsors

East Lancashire Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Manchester - Oxford Foot Questionnaire (MOX-FQ) - measured at baseline then at 6 weeks, 3 months and 12 months post-operatively.

Secondary

MeasureTime frame
1. EuroQol (EQ-5D) 2. Pain visual analogue scale (0=no pain, 10=unbearable pain) 3. American Orthopaedic Foot & Ankle Society Hallux score (AOFAS-Hallux) 4. Hospital length of stay 5. Return to work 6. Complication rate 7. Re-operation rate (failed procedure, removal of metalwork)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026