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

Primary Purpose

Hallux Valgus, Cartilage Damage

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Debridement of the MTP1 cartillage lesion and microfracture
Sponsored by
Tom Lootens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hallux valgus

Exclusion Criteria:

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

Sites / Locations

  • AZ Maria MiddelaresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

MTP1 joint with no cartillage laesion or grade I

MTP1 joint with cartillage laesion > grade I - non treatment

MTP1 joint with cartillage laesion > grade I - treatment

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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)
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.
Change in VAS pain
Visual Analogue Scale pain score - 0 (no pain) to 10 (worse pain)

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2020
Last Updated
January 18, 2021
Sponsor
Tom Lootens
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1. Study Identification

Unique Protocol Identification Number
NCT04716140
Brief Title
Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery
Official Title
Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tom Lootens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Cartilage Damage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MTP1 joint with no cartillage laesion or grade I
Arm Type
No Intervention
Arm Description
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.
Arm Title
MTP1 joint with cartillage laesion > grade I - non treatment
Arm Type
No Intervention
Arm Description
Patients in whom a cartilage lesion> grade 1 is found during surgery randomised in the no treatment group
Arm Title
MTP1 joint with cartillage laesion > grade I - treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Debridement of the MTP1 cartillage lesion and microfracture
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in AOFAS
Description
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
Title
Change in SF36
Description
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
Title
Change in VAS pain
Description
Visual Analogue Scale pain score - 0 (no pain) to 10 (worse pain)
Time Frame
10 days, 5 weeks, 4 months, 1 year
Secondary Outcome Measure Information:
Title
Change in VAS Patient satisfaction
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hallux valgus Exclusion Criteria: younger than 30 years, older than 60 years extra pathologies other than hallux valgus
Facility Information:
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Stam
Phone
+32924628
Ext
20
Email
kathleen.stam@azmmsj.be
First Name & Middle Initial & Last Name & Degree
Tom Lootens, MD
First Name & Middle Initial & Last Name & Degree
Jasper Lambrechts, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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