Hallux Valgus- Radiological and Clinical Predictors for Outcome After Surgery
ConditionHallux Valgus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOstfold Hospital Trust
About this trial
Prospective observational study to evaluate the clinical and radiological predictors for outcome in hallux valgus (HV) corrective surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adult patients accepted for hallux valgus surgery (mild, moderate, severe) at the ØHT will be asked to participate in the study
Disqualifiers
Previous hallux valgus surgery in the same foot
Lack of compliance
Not available for follow-up
Language difficulties (not able to communicate in English or Norwegian)
Trial population
All adult patients accepted for hallux valgus surgery at the ØHT
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Hallux Valgus - chevron osteotomy, lapidus procedure
Procedure/SurgeryThe purpose is to compare the preoperative clinical features (previous medical history, age, BMI, occupational status etc), PROMs (Manchester-Oxford Foot and ankle questionnaire, SF-36, VAS activity scale) and radiological parameters (both two and three dimensional) with the postoperative PROMs (+ likert scale) and the postoperative radiological parameters.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Adult participants operated for Hallux Valgus deformity1 intervention
Trial outcomes
Primary outcomes
1
Comparing the pre and postoperative Manchester-Oxford Foot Questionnaire (MOXFQ) index score in participants operated for hallux valgus deformity
The MOXFQ (Dawson et al., 2006) was developed to measure perceived foot-specific functioning and health-related quality of life. The MOXFQ is supported as the current most valid, reliable and responsive foot \& ankle instrument (Jia, Huang\&Gagnier, 2017). It is available in Norwegian, but has not been validated in its translated form. The score compromises a total of 16 items. They are distributed within 3 dimensions; foot pain (5 items), walking/standing (7 items) and social interaction (4 items) where all items are scored on a 5-point Likert scale, score 0 (best) to 4 (worst). The MOXFQ index score (Morely et al., 2013) will be used as the main outcome and we define an increase of at least 15 points as a successful outcome. We plan to run multiple regression analysis with baseline parameters as well as radiological and Patient-reported outcome measures (PROMs) data as predictors. To account for loss to follow-up we will include 250 patients in this study.
Time frame
Participant enrollment is expected to be completed within 3-4 years time, they will be evaluated preoperatively, 6 weeks, 12 weeks and 52 weeks postoperativelySecondary outcomes
1
Comparing the traditional and newer rotational radiological parameters with PROMs pre and postoperatively
Investing the correlation between the traditional and newer rotational parameters on weighted anterior-posterior and axial radiograph of the forefoot (lateral head shape of first metatarsal, hardy and Clapham tibial sesamoid position, joint congruity, distal metatarsal articular angle (DMAA), intermetatarsal angle (IMA), hallux valgus angle (HVA), metatarsal rotational angle, sesamoid rotational angle) and the PROMs (MOxFQ, SF-36, visual analogue scale (VAS) activity, likert scale) pre and postoperatively
Time frame
Participant enrollment is expected to be completed within 3-4 years time, patient follow-up 6, 12 and 52 weeks postoperatively. Goal of inclusion 250 patients.Sponsors and contacts
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Source ClinicalTrials.gov