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

Hallux Valgus Clinical Trial

Official title:

Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716140
• Other study ID #: MMS.2020.006
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A randomized, single surgeon study in which two groups will be compared with each other:

Group 1: 50 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 to be operative. The grade of the cartilage lesions will be determined on the basis of the ICRS scale and an MS Hololens.

Group 2: 50 patients with a cartilage lesion> grade 1 found during surgery. Whether or not to treat the cartilage injury will be randomly determined. 50 envelopes will be made with 25 treat, 25 not to treat. Just before surgery, Dr. T. Lootens an envelope will be drawn which will determine the further policy of the operation:

Group 2A: 25 patients who are not treated for the cartilage injury. Group 2B: 25 patients who are treated for the cartilage injury by means of debridement of the lesion and microfracture.

The patients who will undergo surgery for hallux valgus will be seen pre-operatively at the outpatient clinic by the investigators. During this consultation, an explanation will be given about the research and the participant will have to sign an informed consent before participating in the study. Here, the participant will also receive an envelope with questionnaires (AOFAS score / SF 36 score / VAS pain and satisfaction), which they will fill out on the day of surgery.

Follow up The participants will be seen again at the orthopedics outpatient clinic for clinical follow-up and filling out questionnaires at 10 days, 5 weeks, 4 months and 1 year postoperatively. This follow up will be done by the co-investigator, who is blinded during the study.

Scientific foundation Corrective hallux valgus surgery currently exists in two ways: open and closed (percutaneous) technique. To date, there is no consensus on the treatment of visible cartilage lesions at the MTP I joint during the open technique. It is not known whether or not treating these injuries has an impact on the patient's clinical outcome. The Principle investigator already treats the serious cartilage lesions (> GR1 lesions) by means of debridement of the lesion, followed by microfracture. As there is no literature available on this topic yet, this research could certainly add value for the therapeutic approach of cartilage lesions at MTP I in the future.

Moreover, if microfracture gives a significantly better clinical outcome, this means that the closed (percutaneous) technique is contraindicated as a corrective technique in patients with hallux valgus. If this is not the case, no cartilage lesions at the level of the MTP I joint need to be taken into account during open technique.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: December 31, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• hallux valgus

Exclusion Criteria:

• younger than 30 years, older than 60 years

• extra pathologies other than hallux valgus

Related Conditions & MeSH terms

• Cartilage Damage
• Hallux Valgus

Intervention

Procedure:
• Debridement of the MTP1 cartillage lesion and microfracture
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

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent

Sponsors (1)

Lead Sponsor	Collaborator
Tom Lootens

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in VAS Patient satisfaction	Visual Analogue Scale Patient satisfaction score - 0 (not satisfied at all) to 10 (very satisfied)	10 days, 5 weeks, 4 months, 1 year