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NCT ID: NCT05082012 Terminated - Hallux Valgus Clinical Trials

Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)

Mini3D
Start date: September 17, 2021
Phase: N/A
Study type: Interventional

Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery. Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.

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: NCT04986358 Active, not recruiting - Hallux Valgus Clinical Trials

Short and Medium Term Postoperative Complications After Hallux Valgus Surgery

HALLUXVALGUS
Start date: January 5, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to make a precise inventory of the complications that may occur postoperatively in the more or less long term in a cohort of patients who should benefit from surgical management of Hallux Valgus.

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: NCT04826328 Completed - Pain, Postoperative Clinical Trials

Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy

Start date: March 15, 2021
Phase: Phase 1
Study type: Interventional

This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy. Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of FX301 will be explored against placebo in four cohorts of 12 patients each (9 active:3 placebo) for the management of post-surgical pain in patients undergoing bunionectomy. Part II - expansion cohort to further assess safety, tolerability, systemic exposure, and efficacy of a selected drug load/volume of FX301. An additional 36 patients will be randomized in a 1:1 ratio to receive either FX301 or placebo as a single-injection analgesic nerve block adjacent to the sciatic nerve of the popliteal fossa.

NCT ID: NCT04823884 Completed - Hallux Valgus Clinical Trials

Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

By means of clinical satisfaction and clinical scores comparison of an open to a minimally invasive distal chevron osteotomy for correction of a hallux valgus deformity is performed.

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.

NCT ID: NCT04715139 Recruiting - Akin Osteotomy Clinical Trials

Evaluate the Continued Safety and Performance of the Foot and Ankle Products

Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

The objective of the registry is to evaluate the continued safety and performance of the Arthrex foot and ankle products including the ProStop implant for hyperpronated foot, Bio-Compression Screw for reconstruction surgeries of the foot, TRIM-IT Drill Pin, TRIM-IT Spin Pin for fixation of fractures and fusion (bunionectomy osteotomies) of the foot/ankle, Headless Compression Screws and Compression FT Screws for fixation of small bone fragments of the foot/ankle and DynaNite® Nitinol Staple to be used for fixation such as Lisfranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus and Beveled Headed FT Screws for osteotomy fixation of Hallux valgus repair (such as Scarf and Chevron etc.)

NCT ID: NCT04614675 Not yet recruiting - Hallux Valgus Clinical Trials

Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

background Hallux valgus (HV) is a common forefoot disorder in need of surgical intervention after failed conservative treatment. Surgical treatment of HV generally includes different kinds of osteotomy in combination with different distal soft tissue procedures (DSTP). Commonly used DSTP are open first-web lateral release, transarticular lateral release (TALR), and percutaneous lateral release (PCLR). In some studies, TALR showed similar surgical outcomes with open first-web space lateral release. Besides, PCLR has been described with satisfactory outcomes. TALR and PCLR are gaining popularity due to their less invasive approach and potential in combination with a distal metatarsal Chevron osteotomy (DMCO). Currently, there is no study comparing the surgical results between TALR and PCLR for surgical reconstruction of HV. Aim The aim of this prospective randomized trial is to compare the surgical outcomes of TALR versus PCLR, both in combination of DMCO, for the treatment of HV. Our hypothesis is that TALR would achieve a better surgical outcomes than PCLR.