Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04716140
Study type Interventional
Source Algemeen Ziekenhuis Maria Middelares
Contact
Status Recruiting
Phase N/A
Start date September 15, 2020
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04473196 - The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion N/A
Recruiting NCT05587569 - Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D) N/A
Recruiting NCT05555459 - Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation N/A
Completed NCT02121119 - Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump Phase 4
Enrolling by invitation NCT00600899 - Home Infusors for Analgesia After Foot Surgery Phase 4
Completed NCT05579054 - Translation, Validity, and Reliability of the Foot Posture Index (FPI-6) - Turkish Version
Terminated NCT05082012 - Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D) N/A
Recruiting NCT05051709 - Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus N/A
Active, not recruiting NCT04145882 - Efficacy of Additional Osteotomies to Correct Hallux Valgus N/A
Completed NCT04468555 - Hallux Valgus Manual Therapy Based on Global Postural Reeducation. N/A
Terminated NCT03257540 - Early Weight-Bearing After Lapidus Arthrodesis
Completed NCT03846687 - Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
Completed NCT04365712 - Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel N/A
Recruiting NCT02282956 - Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery Phase 4
Withdrawn NCT01555216 - Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block N/A
Completed NCT00683137 - Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery Phase 3
Terminated NCT04103814 - Effect of Topical CBD Cream for Degenerative Hallux Disorders Phase 2/Phase 3
Completed NCT03423498 - The Toe-spread-out Exercise in Patients With Hallux Valgus and Without the Deformity N/A
Not yet recruiting NCT06076655 - Hallux Valgus Treatment Developed for Children With Cerebral Palsy N/A
Recruiting NCT02915822 - COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study N/A