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ĎLange termijn uitkomst na hallux rigidus ingreep middels Cheilectomie, Kellerís arthroplasty of Artrodeseí


- candidate number27442
- NTR NumberNTR6435
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jun-2017
- Secondary IDs17-T-09 Z2017012
- Public TitleĎLange termijn uitkomst na hallux rigidus ingreep middels Cheilectomie, Kellerís arthroplasty of Artrodeseí
- Scientific TitleLong-Term Effects of Cheilectomy, Kellerís Arthroplasty and Arthrodesis for Symptomatic Hallux Rigidus on Clinical Outcome and Plantar Pressure: A RETROSPECTIVE COHORT STUDY WITH MORE THAN 17 YEARS FOLLOW-UP.
- ACRONYMMTP-1 artrose
- hypothesisWe hypothesize that, in line with the results of the previous study, cheilectomy and Kellerís 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 Kellerís 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 Kellerís arthroplasty group. Concerning recurrence rate, we expect a high recurrence rate in cheilectomy patients compared to Kellerís arthroplasty patients, while fusion is achieved in >90% of the arthrodesis patients.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Hallux rigidus
- Inclusion criteriaPatients who had participated in the previous study.
- Exclusion criteriaPatients who do not want to contribute or were lost to follow up will be excluded from FU.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-aug-2017
- planned closingdate1-nov-2017
- Target number of participants77
- InterventionsNinety four feet in 77 patients were included in the primary study and were treated with a cheilectomy (n=32), a Kellerís arthroplasty (n=28) and arthrodesis (n=34).
- Primary outcomeThe 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 outcomeThe 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.
- Timepoints+/- 17 year postoperative
- Trial web siten.a.
- status[default]
- CONTACT FOR PUBLIC QUERIESDrs. M.G.M. Schotanus
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryDespite 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.
- Main changes (audit trail)
- RECORD21-jun-2017 - 29-jun-2017


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