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Hallux Valgus clinical trials

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NCT ID: NCT04149626 Recruiting - Sedation Clinical Trials

Dexmedetomidine Sedation in Orthopedic Surgery

Start date: January 29, 2020
Phase: Phase 2
Study type: Interventional

60 patients ASA I-III, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group A (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group B (n=20) where midazolam will be used for sedation (initial bolus dose followed by continuous infusion) and group C (n=20), where remifentanil will be used for sedation (initial bolus dose followed by continuous infusion). All patients will receive spinal anesthesia. Duration of postoperative analgesia, total dose of patient controlled IV morphine, sedation scores, nausea and vomiting, time of ambulation, sleep quality and patient satisfaction will be recorded for the first postoperative day. Additionally chronic pain on the site of surgery will be recorded in 3 and 6 months postoperatively.

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: NCT04103814 Terminated - Hallux Valgus Clinical Trials

Effect of Topical CBD Cream for Degenerative Hallux Disorders

Start date: October 20, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

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: NCT03922412 Completed - Anesthesia Clinical Trials

Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery

Plantar-block
Start date: June 24, 2019
Phase: N/A
Study type: Interventional

Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation. Sciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade. Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation. This study aims to determine the quality of deambulation following hallux valgus surgery. Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study. Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited. Consenting patients will be randomized the day of surgery to one of those two groups : 1. Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml). 2. Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone) All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously. During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption. Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital. Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet. Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.

NCT ID: NCT03884907 Recruiting - Hallux Valgus Clinical Trials

Human Bone Graft for Hallux Valgus Correction According to the Austin Procedure

Start date: March 21, 2018
Phase:
Study type: Observational [Patient Registry]

This observational study is to document the application of a human bone graft in the surgical repair of hallux valgus deformity and its subsequent healing process.

NCT ID: NCT03846687 Completed - Hallux Valgus Clinical Trials

Validation of Patient Reported Outcome Measures for Use in Hallux Valgus

Start date: October 30, 2018
Phase:
Study type: Observational

The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).

NCT ID: NCT03843177 Completed - Flat Foot Clinical Trials

Association of Ingrown Toenails With Flat Foot, Hallux Abducto Valgus and Hallux Limitus

Start date: March 14, 2018
Phase:
Study type: Observational

This study will have implications for any healthcare professionals who routinely manage ingrown toenails. Although different conservative and surgical treatment have been suggested, the recurrent rate is still high ranging from 20% to 30%. The objective of this study was to investigate the association of ingrown toenail (IGTN) with flat foot, hallux abducto valgus (HAV) and hallux limitus (HL), and to provide directions for addressing biomechanical risk factors in the prevention of recurrent ingrown toenails. This was the first study to investigate the association of IGTN with flat foot, and the first study in Chinese community to investigate the association of IGTN with HAV or HL. Participants with ingrown toenails (IGTN) were recruited to this study and compared with control participants with no history of ingrown toenails. The inclusion criteria for the IGTN group were: (1) history of ingrown toenails on hallux within 1 year and (2) dorso-plantar standing view of foot x-ray taken or to be taken. The exclusion criteria for the IGTN group were: (1) paediatrics (Age<18), (2) pincer nails / fungal nails, (3) prior existence of osteoarticular surgery in the foot, (4) severe trauma that changes foot morphology, (5) uncontrolled systemic disease, (6) pre-existing neurological diseases and (7) lower limb paralysis or paresis. The inclusion criterion for the control group was dorso-plantar standing view of foot x-ray taken or to be taken. The exclusion criteria for the control group were: (1) all the exclusion criteria of IGTN group, (2) history of IGTN in his or her lifetime and (3) flatfoot / first metatarsophalangeal joint pathology as the chief complaint. The symptomatic foot (or the more symptomatic foot in the case of bilateral involvement) in the IGTN group was examined. The left or right foot of the control group was randomly selected such that the ratio of the left or the right foot in the IGTN and control group was the same. Their foot posture index-6 components, Staheli's index, radiological hallux valgus angle and active maximum dorsiflexion of the first metatarsophalangeal joint on weight-bearing were measured and compared. For dependent variables with significant correlation, a one-way multivariate analysis of variance (MANOVA) was carried out to determine if there was a significant difference on the combined dependent variables. For dependent variables without significant correlation, separate independent sample t-tests / welch t-tests were performed.

NCT ID: NCT03838133 Completed - Hallux Valgus Clinical Trials

A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy

Start date: March 5, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult subjects following bunionectomy.