Hallux Valgus- Radiological and Clinical Predictors for Outcome After Surgery

NCT04851249 | Recruiting

• 1 other identifier: 217200
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational study to evaluate the clinical and radiological predictors for outcome in hallux valgus (HV) corrective surgery.

Conditions

Hallux Valgus

Keywords

Hallux valgus; Outcome predictors; MOXFQ

Outcome Measures

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.

  Participant enrollment is expected to be completed within 3-4 years time, they will be evaluated preoperatively, 6 weeks, 12 weeks and 52 weeks postoperatively

Secondary Outcomes (1)

• Comparing the traditional and newer rotational radiological parameters with PROMs pre and postoperatively

  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.

Study Arms (1)

Adult participants operated for Hallux Valgus deformity

All adult participants accepted for hallux valgus corrective surgery at ostfold hospital trust (ØHT) is asked to participate in the study. The goal is to include 200-250 participants.

Procedure: Hallux Valgus - chevron osteotomy, lapidus procedure

Interventions

Hallux Valgus - chevron osteotomy, lapidus procedure PROCEDURE

The 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.

Adult participants operated for Hallux Valgus deformity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients accepted for hallux valgus surgery at the ØHT

You may qualify if:

• All adult patients accepted for hallux valgus surgery (mild, moderate, severe) at the ØHT will be asked to participate in the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ostfold Hospital Trust: lead

Study Sites (1)

Østfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Marius Molund, MD, PhD

  Head of foot and ankle department at ØHT

  STUDY DIRECTOR

Central Study Contacts

Marius Molund, MD, PhD

CONTACT

004790093988; marius.molund@so-hf.no

Mikaela Engarås Hamre, MD

CONTACT

004741273586; mikaela.engaras.hamre@so-hf.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 20, 2021
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

NO (1)