Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery

NCT04716140 | Recruiting

• 1 other identifier: MMS.2020.006
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the point or nonsense of treating cartilage lesions at the level of the first metatarsophalane joint. To date, no clear guidelines have been found in the literature with regard to the treatment of cartilage lesions at the MTP I joint during corrective surgery for hallux valgus, nor has it been investigated whether this can have an effect on the clinical outcome.

Conditions

Hallux Valgus; Cartilage Damage

Outcome Measures

Primary Outcomes (3)

• Change in AOFAS

  American Orthopaedic Foot and Ankle Society (AOFAS) score - combines a clinician-reported and a patient-reported part for measuring the outcome of treatment in patients who sustained a complex hindfoot injury based on pain, function and alignment: 0 (bad outcome) to 100 (very good outcome)

  10 days, 5 weeks, 4 months, 1 year

• Change in SF36

  Short Form 36 (SF-36) Health Survey - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  10 days, 5 weeks, 4 months, 1 year

• Change in VAS pain

  Visual Analogue Scale pain score - 0 (no pain) to 10 (worse pain)

  10 days, 5 weeks, 4 months, 1 year

Secondary Outcomes (1)

• Change in VAS Patient satisfaction

  10 days, 5 weeks, 4 months, 1 year

Study Arms (3)

MTP1 joint with no cartillage laesion or grade I

NO INTERVENTION

Patients in whom no treatment of the cartilage lesions is performed: these patients have no cartilage lesion or a grade I cartilage lesion at the MTP I joint that has been found peroperatively. The degree of the cartilage lesions will be determined on the basis of the ICRS scale and an MS Hololens.

MTP1 joint with cartillage laesion > grade I - non treatment

NO INTERVENTION

Patients in whom a cartilage lesion\> grade 1 is found during surgery randomised in the no treatment group

MTP1 joint with cartillage laesion > grade I - treatment

EXPERIMENTAL

Patients in whom a cartilage lesion\> grade 1 is found during surgery randomised in the treatment group. They will be treated through debridement of the lesion and microfracture.

Procedure: Debridement of the MTP1 cartillage lesion and microfracture

Interventions

Debridement of the MTP1 cartillage lesion and microfracture PROCEDURE

Patients with a MTP1 cartillage lesion \> grade I (based on based on the ICRS scale and an MS HoloLens measurement) randomised in the treatment group will be treated with debridement and microfracture

MTP1 joint with cartillage laesion > grade I - treatment

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• hallux valgus

You may not qualify if:

• younger than 30 years, older than 60 years
• extra pathologies other than hallux valgus

Sponsors & Collaborators

• Tom Lootens: lead

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: January 20, 2021
• Study Start: September 15, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)