Hallux ValgusNCT04716140
Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery
A study testing Debridement of the MTP1 cartillage lesion and microfracture in people with Hallux Valgus and Cartilage Damage, run by Tom Lootens at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hallux Valgus, Cartilage Damage
- What is being tested?
- Debridement of the MTP1 cartillage lesion and microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- hallux valgus
Who cannot join
- younger than 30 years, older than 60 years
- extra pathologies other than hallux valgus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Maria Middelares
Ghent, 9000
Kathleen Stam, +32924628 ext. 20, kathleen.stam@azmmsj.be
Tom Lootens, MD
About this study
Official title: Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions
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.
Read the 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.
- Conditions
- Hallux Valgus, Cartilage Damage
- Being tested
- Debridement of the MTP1 cartillage lesion and microfracture
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debridement of the MTP1 cartillage lesion and microfractureProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Debridement of the MTP1 cartillage lesion and microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 10 days, 5 weeks, 4 months, 1 year
Change in VAS pain
Visual Analogue Scale pain score - 0 (no pain) to 10 (worse pain)
Measured: 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)
Measured: 10 days, 5 weeks, 4 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start15 Sep 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tom Lootens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tom Lootens, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716140
- Sponsor's protocol ID
- MMS.2020.006
- Status last verified
- Mar 2025
- First submitted
- 9 Nov 2020
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions
- ClinicalTrials.gov ID
- NCT04716140
- Acronym / sponsor ID
- MMS.2020.006
- Conditions
- Hallux Valgus, Cartilage Damage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Tom LootensUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Debridement of the MTP1 cartillage lesion and microfracturePatients 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- hallux valgus
Key exclusion criteria (2 listed)
- younger than 30 years, older than 60 years
- extra pathologies other than hallux valgus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debridement of the MTP1 cartillage lesion and microfracturePatients 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 | Procedure or surgery | MTP1 joint with cartillage laesion > grade I - treatment |
Primary outcome
Change in AOFAS
Time frame: 10 days, 5 weeks, 4 months, 1 year
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
Time frame: 10 days, 5 weeks, 4 months, 1 year
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
Time frame: 10 days, 5 weeks, 4 months, 1 year
Visual Analogue Scale pain score - 0 (no pain) to 10 (worse pain)
1 secondary outcome
Change in VAS Patient satisfaction
Time frame: 10 days, 5 weeks, 4 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debridement of the MTP1 cartillage lesion and microfracture in people with Hallux Valgus and Cartilage Damage, run by Tom Lootens at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AOFAS (time frame: 10 days, 5 weeks, 4 months, 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.