Health TrialsbyHealthPanel

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

ConditionsHallux ValgusCartilage Damage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorTom Lootens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

hallux valgus

Disqualifiers

younger than 30 years, older than 60 years

extra pathologies other than hallux valgus

Trial design

Design model

Parallel

Treatments tested in this trial

  • Debridement of the MTP1 cartillage lesion and microfracture

    Procedure/Surgery

    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

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: MTP1 joint with no cartillage laesion or grade INo intervention 0 interventions
Group B: MTP1 joint with cartillage laesion > grade I - non treatmentNo intervention 0 interventions
Group C: MTP1 joint with cartillage laesion > grade I - treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
10 days, 5 weeks, 4 months, 1 year
2

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.

Time frame
10 days, 5 weeks, 4 months, 1 year
3

Change in VAS pain

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

Time frame
10 days, 5 weeks, 4 months, 1 year

Secondary outcomes

1

Change in VAS Patient satisfaction

Visual Analogue Scale Patient satisfaction score - 0 (not satisfied at all) to 10 (very satisfied)

Time frame
10 days, 5 weeks, 4 months, 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tom Lootens

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Sponsor institution

Source ClinicalTrials.gov
Apply now