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Bunion clinical trials

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NCT ID: NCT04518462 Completed - Bunion Clinical Trials

Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries

STRIDE
Start date: October 20, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.

NCT ID: NCT04468555 Completed - Hallux Valgus Clinical Trials

Hallux Valgus Manual Therapy Based on Global Postural Reeducation.

HVMT
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Manual approach of Hallux Valgus with global postural reeducation.

NCT ID: NCT04398329 Completed - Bunions Clinical Trials

Dose-Escalation Study of HTX-034 Following Bunionectomy

Start date: May 18, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b will evaluate escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 will be a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b compared with bupivacaine HCl.

NCT ID: NCT04393545 Completed - Hallux Valgus Clinical Trials

Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus

Start date: February 2, 2009
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effects of splinting, exercise and electrotherapy on the hallux valgus (HV) angle, and foot-specific health-related quality of life. Sixty women (120 feet) with bilateral HV deformity were randomly assigned to one of three groups - an HV night splint (SP) group, an exercise (EX) group, and a high-voltage galvanic stimulation (EL) group. Angular degrees (hallux interphalangeal, HV, and intermetatarsal angles expressed as angles A, B and C, respectively) were determined before enrollment (t0) and three months after treatment (t2). Foot-specific quality of life was assessed using the Manchester-Oxford Foot Questionnaire (MOFQ) at t0, after one month (t1), and at t2. All groups exhibited significant changes in the A, B, and C angles and outcome measures (p ≤0.001). Decreases in the A and C angles, and MOFQ-Pain subscale scores, were higher in the SP group than in the other two groups (p<0.05). C angle at t2, MOFQ-Walking score at t1 and t2 and MOFQ-Pain subscale score at t1 were lower in the SP group (p<0.05).

NCT ID: NCT04365712 Completed - Hallux Valgus Clinical Trials

Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel

Piezo-Hallux
Start date: October 24, 2014
Phase: N/A
Study type: Interventional

The main goal of the surgical correction of the hallux valgus is the morphological correction associated with the functional rebalancing of the first ray. The aim of this study was to show the efficacy of piezosurgery in performing distal linear osteotomy of the first metatarsal bone in hallux valgus correction, in terms of clinical and radiological outcomes at 1-year final follow up.

NCT ID: NCT04284618 Completed - Hallux Valgus Clinical Trials

Off Axis View Radiographs Assessing Hallux Valgus Interphalangeus in Hallux Valgus Deformity

Start date: November 10, 2018
Phase:
Study type: Observational

In hallux valgus deformity an additional deformity of the proximal phalangeal bone can be observed frequently as well. Due to a hyperpronation of the greater toe on standardized radiographs the deformity defining angles are likely to be underestimated. Therefore the investigators developed an off axis view radiograph for determining the real deformity. This study compares the standardized and the off axis view radiographs.

NCT ID: NCT04145882 Active, not recruiting - Hallux Valgus Clinical Trials

Efficacy of Additional Osteotomies to Correct Hallux Valgus

Start date: September 11, 2019
Phase: N/A
Study type: Interventional

Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). Angle between M1 and the second metatarsal (M2) is named InterMetatarsal Angle (IMA). Angle between M1 distal articular surface and M1 shaft axis in a frontal plane is named Distal Metatarsal Articular Angle (DMAA). Insufficient surgical correction is a risk factor of recurrence (HVA>20° after surgery). According to Okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : HVA>40° before the surgery and HVA>15° with an IMA>10° 10 weeks (3-24) after the surgery. Currently, one of the most common used procedure is a translated (laterally) distal chevron associated with a release of the metatarso-sesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct deformation in all plans. HVA and IMA are corrected but DMAA and M1 pronation angle are not. Surgeons can add three different osteotomies in this type of chevron. In the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. No studies have tried to assess these three possibilities. The investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up

NCT ID: NCT04088214 Completed - Hallux Valgus Clinical Trials

Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Lateral soft tissue release is commonly performed as part of the surgical correction of hallux valgus. This study will look at the results form a series of patients whom have underwent the arthroscopic lateral soft tissue release.

NCT ID: NCT04084262 Completed - Hallux Valgus Clinical Trials

Multi-Plane Hallux Valgus Correction With the Phantom® Nail

Start date: November 7, 2019
Phase:
Study type: Observational

The goal of this research study is to determine the change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st TMT joint with the Phantom® Intramedullary Nail combined with a supinating reduction technique. The study hypothesis is that multi-planar correction can be achieved with the Phantom® Intramedullary Nail.

NCT ID: NCT04002089 Completed - Bunion Clinical Trials

Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In Popliteal Fossa), for Postsurgical Analgesia in Subjects Undergoing Bunionectomy

Start date: July 26, 2019
Phase: Phase 1
Study type: Interventional

This is a pilot, open label, single center study in 40 subjects undergoing bunionectomy. The study will assess and collect information on pharmacokinetics, pharmacodynamics, safety and efficacy of EXPAREL administered as a sciatic nerve block (in popliteal fossa). A total of 10 subjects will be enrolled in each of the 4 cohorts.