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Hallux Valgus clinical trials

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NCT ID: NCT03481725 Completed - Clinical trials for Anterior Cruciate Ligament Reconstruction

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Pilot Study

Start date: July 14, 2018
Phase: N/A
Study type: Interventional

Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief. A novel, non-pharmacologic analgesic technique-percutaneous peripheral nerve stimulation (PNS)- holds extraordinary potential to greatly reduce or obviate opioid requirements and concurrently improve analgesia following painful surgery. This technique involves inserting an insulated electric lead adjacent to a target nerve through a needle prior to surgery using ultrasound guidance. Following surgery, a tiny electric current is delivered to the nerve resulting in potent pain control without any cognitive or adverse systemic side effects whatsoever. The electrical pulse generator (stimulator) is so small it is simply affixed to the patient's skin. The leads are already cleared by the US Food and Drug Administration to treat acute (postoperative) pain for up to 60 days; and, since percutaneous PNS may be provided on an outpatient basis, the technique holds the promise of providing potent analgesia outlasting the pain of surgery-in other words, the possibility of a painless, opioid-free recovery following surgery. The current project is a multicenter, randomized, double-masked, placebo-controlled, parallel-arm clinical pilot study to (1) determine the feasibility and optimize the protocol of a planned definitive clinical trial; and (2) estimate the treatment effect of percutaneous PNS on pain and opioid consumption following moderate-to-severely painful ambulatory surgery compared with usual and customary opioid-based analgesia. This will allow determination of the required sample size for a subsequent definitive multicenter clinical trial. Combined, the pilot study and definitive trial have a strong potential to dramatically reduce or obviate postoperative opioid requirements and their resultant negative effects on both individuals and society; while concurrently improving analgesia, increasing the ability to function in daily life, decreasing the risk of transition from acute to chronic pain, and improving quality of life.

NCT ID: NCT03470623 Not yet recruiting - Hallux Valgus Clinical Trials

Comparison of Bioabsorbable and Steel Screw for the Treatment of Hallux Valgus With Chevron Osteotomy

Start date: March 2018
Phase: N/A
Study type: Interventional

Hallux valgus is the most common deformity of forefoot and the patients would suffer pain and disable of walking and wearing normal shoes. Chevron osteotomy of the first metatarsal is widely used for the treatment of mild or medium hallux valgus. It is a "V" sharp osteotomy that can decrease the intermetatarsal degree of first-second metatarsal by pushing the distal side of osteotomy laterally.A 2.5mm or 3.0mm steel cannulated screw is usually used for the fixation of the osteotomy side to provide stability.However,there are some shortcomings of steel screws such as rejection of internal fixation or the financial cost of the second surgery of fixation taken-out. To obviate these shortcomings of steel screws, bioabsorbable screw fixation may be an alternative method for chevron osteotomy. This trial is a randomized, prospective, controlled, parallel experimental design, to compare the clinical and radiographic outcomes of bioabsorbable screw versus steel screw for the treatment of hallux valgus with chevron osteotomy. The patients will be randomized to two groups, one treated with bioabsorbable screws while the other treated with steel screws.Data collection for the outcomes measures will occur pre-op,immediate post-op and then 6 weeks, 12 weeks, and at 1 years post operation. The clinical outcomes measure are the VAS (visual analogue scale) score and AOFAS (American orthopedic foot and ankle society) forefoot score.The radiographic outcomes measures are the IMA (intermetatarsal angle) and the HVA (hallux valgus angle)

NCT ID: NCT03468491 Not yet recruiting - Clinical trials for Patellofemoral Pain Syndrome

The Additional Effect of Hallux Valgus Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome

Start date: June 20, 2018
Phase: N/A
Study type: Interventional

The study purpose is to investigate the effectiveness of a program combining biomechanical taping with lower extremity neuromuscular exercises for runners with patellofemoral pain syndrome (PFPS) and hallux valgus

NCT ID: NCT03423498 Completed - Hallux Valgus Clinical Trials

The Toe-spread-out Exercise in Patients With Hallux Valgus and Without the Deformity

Start date: October 20, 2015
Phase: N/A
Study type: Interventional

The effectiveness of conservative treatment of hallux valgus deformity has not been sufficiently explored yet. The aim of this study was to assess the effect of the toe-spread-out exercise on the amplitude and frequency pattern in a surface electromyographic examination in patients with hallux valgus and in people without the deformity. An additional objective is the assessment of nerve conduction in an electroneurography and the assessment of range of motion in a clinical examination.

NCT ID: NCT03414593 Active, not recruiting - Pain, Postoperative Clinical Trials

Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery

Start date: January 2, 2018
Phase: N/A
Study type: Interventional

The purpose of this study was to investigate the preemptive effect of ultrasound guided popliteal scistic nerve block on postoperative acute pain in patients with bilateral hallux valgus. After induction of general anesthesia, the leg to be operated first is decided randomly. After the operation of one leg is completed, PSNB is performed on both legs with 0.2% Ropivacaine and surgery is started on the remaining legs. When the surgery is over, check to see which foot pain begins first, how strong the pain is, and whether there are any side effects.

NCT ID: NCT03396991 Completed - Pain, Postoperative Clinical Trials

Comparative Evaluation of Two Different Post-Operative Analgesia After Hallux Valgus Correction

Start date: July 1, 2017
Phase:
Study type: Observational [Patient Registry]

Background: Recent studies showed the efficiency of several techniques of anesthesia in foot surgery. The new mini-invasive surgical approaches should require less analgesia and rapid motor recovery after surgery. The aim of this study was the evaluation of two different techniques on postoperative analgesia and motor recovery after hallux valgus correction in one-day surgery patients.

NCT ID: NCT03340415 Completed - Clinical trials for Hallux Valgus and Bunion

Timing of Weight Bearing After Hallux Valgus Surgery

Start date: July 13, 2018
Phase: N/A
Study type: Interventional

Investigate the optimal timing for weight bearing after Hallux Valgus surgery. Hypothesis: Early weight bearing does not affect outcome after the Endoscopic Distal Soft Tissue Procedure for Hallux Valgus Correction.

NCT ID: NCT03307837 Completed - Clinical trials for Hallux Valgus Deformity

A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity

Start date: November 2, 2017
Phase: Phase 1
Study type: Interventional

This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo.

NCT ID: NCT03257540 Terminated - Hallux Valgus Clinical Trials

Early Weight-Bearing After Lapidus Arthrodesis

Start date: October 31, 2017
Phase:
Study type: Observational

The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantomâ„¢ Intramedullary Nail. The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis procedure with the Phantomâ„¢ Intramedullary Nail and participate in an early weight-bearing protocol will be non-inferior to union rates previously published for this procedure.

NCT ID: NCT03133039 Recruiting - Hallux Valgus Clinical Trials

A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

The investigators sought to determine whether bioabsorbable cannulated screws could perform as well as titanium cannulated screws in the Lapidus procedure and MTP1-joint arthorodesis in anatomical models and clinical series of the foot.