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NCT ID: NCT06460909 Recruiting - Clinical trials for Hallux Valgus Surgery

Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery

PrePS HV
Start date: February 2, 2023
Phase: N/A
Study type: Interventional

Catastrophizing is a negative evaluation of events. What surgery concerns, pain catastrophizing is one of the main risks of postoperative pain and / or poor functional recovery. The best survey to evaluate pain catastrophizing is the PCS (Pain Catastrophizing Scale). According to the authors, catastrophizers report more negative pain related thoughts, more emotional distress and more pain than non-catastrophizers. The PCS is a significant predictor of pain intensity and so of poor functional recovery. It is already well known that anxiety and catastrophizing predict postoperative pain. The actual studies focus mainly on functional recovery of knee and hip arthroplasties, but less on pain and functional recovery of hallux valgus surgery. According to several authors, adapted psychological support of preoperative catastrophizing could allow a better postoperative evolution. Our hypothesis is that a preoperative psychological consultation of catastrophizing patients is efficient to lower pain catastrophizing in adult patients undergoing a surgical operation for hallux valgus. The first objective is to evaluate the impact of a psychological support of preoperative pain catastrophizing during a hallux valgus surgery.The principal evaluation scale is the pain catastrophizing score before and after surgery. The second objective is to evaluate the pain and functional recovery of pain catastrophizing patients. The criteria of this survey are: anxiety score (usual and actual), pain and function according to the FAOS (Foot and Ankle Outcome Score) pain (Analogic Visual Scale).

NCT ID: NCT05880407 Recruiting - Hallux Valgus Clinical Trials

Pilot Study of Percutaneous Correction of Hallux Valgus

hallux valgus
Start date: February 22, 2022
Phase: N/A
Study type: Interventional

This is a pilot study with a randomized controlled design.

NCT ID: NCT05831449 Recruiting - Bunion Clinical Trials

CPL-01 in the Management of Postoperative Pain After Bunionectomy

Start date: May 22, 2023
Phase: Phase 3
Study type: Interventional

Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.

NCT ID: NCT05773846 Recruiting - Bunion Clinical Trials

A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain

Start date: March 13, 2023
Phase: Phase 3
Study type: Interventional

PRF-110 is a viscous, yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia. The pharmacokinetic profile for PRF-110 suggests that its effect could last up to 72 hours. This is A Phase 3, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy

NCT ID: NCT05587569 Recruiting - Hallux Valgus Clinical Trials

Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

MTA3D
Start date: September 28, 2022
Phase: N/A
Study type: Interventional

Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction. Up to 80 subjects will be treated in this study at up to 13 clinical sites. Patients 14 years through 65 years with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.

NCT ID: NCT05361317 Recruiting - Hallux Valgus Clinical Trials

Correction of Hallux Valgus With the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device

PECA
Start date: June 13, 2022
Phase: N/A
Study type: Interventional

The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices. The primary objective of the study is to confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation functional capacities of the patient's foot. It will be assessed with "general sub-score" of the EFAS questionnaire determined during the postoperative visit at 6 months. The evaluation of quality of life scores, angular correction, bone consolidation and occurrence of adverse events will also be carried out.

NCT ID: NCT05051709 Recruiting - Hallux Valgus Clinical Trials

Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

Hallux valgus can be associated with hypermobility of 1st ray. Surgical decision for hallux valgus can be affected by hyper mobility of 1st ray so our clinical trial involved patients with bilateral hallux valgus were planned to underwent fusion of 1st ray and soft tissue correction plus bonionectomy for one foot and for other foot surgical treatment involves corrective osteotomy and soft tissue procedure plus bonionectomy without fusion of 1st tarsometatarsal joint.

NCT ID: NCT05000398 Recruiting - Exercise Clinical Trials

Comparison of the Effects of Advanced Exercise Treatment Performed Under the Supervision of a Physiotherapist and Provided as a Home Program on Adduction Angle, Pain, Functional Status, Quality of Life and Kinesophobia in Individuals With Hallux Valgus

Start date: May 24, 2021
Phase: N/A
Study type: Interventional

The aim of our study is to compare the effects of progressive exercise therapy, administered as a home program under the supervision of a physiotherapist, on adduction angle, pain, functional status, quality of life, and kinesiophobia in individuals aged 18-64 years with a hallux valgus angle of 15-40 degrees (mild-moderate).

NCT ID: NCT04851249 Recruiting - Hallux Valgus Clinical Trials

Hallux Valgus- Radiological and Clinical Predictors for Outcome After Surgery

Start date: January 1, 2022
Phase:
Study type: Observational

Prospective observational study to evaluate the clinical and radiological predictors for outcome in hallux valgus (HV) corrective surgery.

NCT ID: NCT04751344 Recruiting - Postoperative Pain Clinical Trials

Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery

Start date: June 16, 2020
Phase: Phase 4
Study type: Interventional

Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.