View clinical trials related to Hallux Valgus.
Filter by: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.
The prospective, post-market, single-center clinical study will include 45 subjects who are candidates for surgery using the Arthrex QuickFix Small Staple for Akin osteotomy to correct hallux valgus interphalangeus. The purpose of the study is to evaluate the continued safety and effectiveness of the device. Device-related adverse events as well as patient reported outcomes (VAS, FFI, FAAM, VR-12) will be collected up to 1 year postoperative.
Hallux Valgus (HV) is a lateral deviation of the big toe. HV is a deformity of the forefoot centered on the 1st radius (1st metatarsal and big toe). This deformation is characterized by: - a big toe (hallux) deviated outwards (valgus greater than 12 °) - a first metatarsal moved medially (varus) (angle M1 / M2> 10 °). We also note the existence of an exostosis formed by the apex of the angle between the 1st metatarsal deviated inwards and the big toe deported outwards. This exostosis corresponds to the head of the 1st metatarsal. In addition to the pain and the unaesthetic nature induced by this deviation, the modifications of the skeletal axes of the foot cause disorders of its function but also of the joints of the lower limb during standing, walking and running. Axis defects of the lower limbs in varum or valgum also cause deformities in the rearfoot, midfoot and forefoot. There is no non-surgical curative treatment for this deformity. Different conservative treatment options have been offered for first-line treatment, including different types of physiotherapy, wearing rigid insoles or splints. Wearing rigid insoles is indicated to "counter" the valgic pressure, thereby reducing pain and high plantar pressure, in patients with HV. Their hardness, expressed in SHORE units, must be greater than 65. By countering the valgic pressure (rearfoot and midfoot), the rigid soles make it possible to contain the development of deformation and stabilize the axis of the first spoke. The speed of hallux deformation is therefore greatly reduced if the soles are worn diligently. But there is little or no impact on the correction of the deformity, but it is stabilized as it is without rapid and major worsening. Indeed, soles with a hardness greater than or equal to 65 SHORE make it possible to avoid the valgum of the hindfoot and midfoot under load and when walking. Wearing a dynamic splint was studied in a recently published prospective randomized study conducted between 2011 and 2013. This study, concluding that the dynamic splint is not effective in reducing the angle of deformation of the HV, nevertheless shows the reduction in pain during walking and running. The limits of the study lie in the pace of wearing the splint, left to the discretion of patients, during their rest period, and in the duration of the operation, which is not precisely described.
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.
The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail. The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing protocol will be non-inferior to union rates previously published for this procedure.
Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).
This study is an observational "change from baseline" outcome measures design. Data is collected for the sake of evaluating treatment (fusion surgery) performed as standard medical care, but the investigator does not assign specific interventions to any participants in this study.