No registrations found.
ID
Source
Brief title
Health condition
Osteoarthritis (OA) of the first metatarsophalangeal (MTP1) joint, also known as hallux rigidus (HR)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this FU study will be the clinical outcome of treatment for HR measured with the modified AOFAS-HMI scale and Visual Analogue Score for Pain.
Secondary outcome
The secondary outcome includes patient reported satisfactory and outcome measured with the SF-36, MOXFQ and FJS questionnaires and dynamic plantar pressures. Patients dissatisfactory will be defined as less than 9 points in total on the three five-points satisfactory questions in the general questionnaire. As outcome for the plantar pressure analyses, both peak pressures and pressure-time integrals will be used. Recurrence of HR is defined as a comparable or increase in grade of HR, determined based on the Regnaulds score.
Background summary
Despite the extensive literature on the surgical treatment of HR, no studies with a follow up exceeding 10 years are available. Pain might be one of the main reasons to treat the first ray in patients with HR, but in the long-term creating a permanent satisfactory correction resulting in a restoration of the weight bearing function of the first ray is indispensable. Therefore, this study will be conducted to assess patient satisfactory, clinical and subjective patient reported outcome and plantar pressure after surgical treatment for HR.
Study objective
We hypothesize that, in line with the results of the previous study, cheilectomy and Keller’s arthroplasty show better clinical and subjective outcome in patients treated for low grade HR compared to arthrodesis. In addition, we hypothesize that clinical and subjective outcomes are comparable for high grade HR treated with Keller’s arthroplasty or arthrodesis after >17 years of FU. Concerning plantar pressure, we expect that cheilectomy restores the weightbearing function of the first ray, while a shift of load to the lesser metatarsals will be observed in the arthrodesis and Keller’s arthroplasty group. Concerning recurrence rate, we expect a high recurrence rate in cheilectomy patients compared to Keller’s arthroplasty patients, while fusion is achieved in >90% of the arthrodesis patients.
Study design
+/- 17 year postoperative
Intervention
Ninety four feet in 77 patients were included in the primary study and were treated with a cheilectomy (n=32), a Keller’s arthroplasty (n=28) and arthrodesis (n=34).
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
Inclusion criteria
Patients who had participated in the previous study.
Exclusion criteria
Patients who do not want to contribute or were lost to follow up will be excluded from FU.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6261 |
| NTR-old | NTR6435 |
| Other | Z2017012 : 17-T-09 |
Summary results
Long-term Follow-up of a Randomized Controlled Trial Comparing Scarf to Chevron Osteotomy in Hallux Valgus Correction.
Jeuken RM, Schotanus MG, Kort NP, Deenik A, Jong B, Hendrickx RP