Clinical trials: Hallux Valgus
Bunionectomy, Hallux Valgus
Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy
The study is conducted sequentially in two parts. Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg…
- Trial name
- NCT05157841
- Testing
- Bupivacaine liposome injectable suspension 266 mg, Bupivacaine HCl, Bupivacaine liposome injectable suspension 133 mg
- Where
- 7 sites in United States
- Volunteers
- 185 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Hallux Valgus Interphalangeus
Safety and Effectiveness of the QuickFix Small Staple
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.
- Trial name
- NCT04776356
- Testing
- QuickFix Small Staple (Arthrex)
- Where
- Germany
- Volunteers
- 12 people
- Sponsor
- Arthrex GmbH
Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
- Conditions
- Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- MINITAC (NCT04186481)
- Testing
- MINITAC Ti 2.0 suture anchor
- Where
- Australia
- Volunteers
- 32 people
- Sponsor
- Smith & Nephew, Inc.
Hallux Valgus
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
The purpose of this study is to assess the surgeon experience and surgery outcomes in participants undergoing index Lapidus procedure for the correction of hallux valgus (a foot deformity where the big toe angles outward towards…
- Trial name
- NCT07567092
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- DePuy Synthes Products, Inc.
Hallux Valgus Deformity
Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves
This study is looking to test a non-compressive semiconductor embedded ankle sleeve and sock for post hallux valgus correction surgery rehabilitation.
- Trial name
- NCT07422623
- Testing
- Semiconductor embedded ankle sleeve and sock
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- INCREDIWEAR HOLDINGS, INC.
Pain
Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy
The primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. Placebo in the management of acute postoperative pain in patients undergoing bunionectomy.
- Trial name
- NCT00656578
- Testing
- 4975
- Where
- 6 sites in United States
- Volunteers
- 300 people
- Sponsor
- Anesiva, Inc.
Hallux Valgus, Bunionectomy
Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
This is a Phase 2, randomized, double-blind, active-controlled, dose-escalation study evaluating the safety, pharmacokinetics, efficacy, and pharmacodynamics of ALX006, an extended-release bupivacaine formulation, administered as…
- Trial name
- NCT07574385
- Testing
- ALX006 (bupivacaine extended-release injection), Bupivacaine Hcl 0.25% Inj, Sciatic Nerve Block
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Rebel Medicine Inc
Hallux Valgus and Bunion
Post-Operative Pain and Opioid Reduction Trial After Bunionectomy
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.
- Trial name
- MERIT-2 (NCT05411861)
- Testing
- Analgesic Non Narcotic
- Where
- 3 sites in United States
- Volunteers
- 73 people
- Sponsor
- Cali Pharmaceuticals LLC
Hallux Valgus, Hallux Varus
Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy may be more indicated than the distal osteotomy as it allows to achieve a greater degree of correction.
- Conditions
- Hallux Valgus, Hallux Varus, Vicious Callus on M1
- Trial name
- NCT01284998
- Where
- 3 sites in France, Lebanon and 1 more
- Volunteers
- 85 people
- Sponsor
- Integra LifeSciences Services
Hallux Valgus Deformity
A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity
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.
- Trial name
- NCT03307837
- Testing
- CA-008
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Concentric Analgesics
Hallux Valgus
Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery
Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe…
- Trial name
- NCT00388011
- Testing
- Intranasal Morphine (MNS075) 3.75 mg, Intravenous Morphine 7.5 mg, Intranasal morphine (MNS075) 7.5 mg
- Volunteers
- 187 people
- Sponsor
- Javelin Pharmaceuticals
Metatarsus Adductus, Hallux Valgus
Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction.
- Trial name
- MTA3D (NCT05587569)
- Testing
- Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
- Where
- 9 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Treace Medical Concepts, Inc.
Arthrodesis, Bunion
Early Weight-Bearing After Lapidus Arthrodesis
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.
- Conditions
- Arthrodesis, Bunion, Hallux Valgus
- Trial name
- NCT03257540
- Testing
- Small Bone Intramedullary Nail
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Paragon 28
Medial Malleolus Fracture, Lisfranc Injury
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations…
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture
- Trial name
- NCT05555459
- Testing
- Operation
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Inion Oy
Hallux Valgus, Bunion
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
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.
- Trial name
- Mini3D (NCT05082012)
- Testing
- Treatment of Hallux Valgus
- Where
- 10 sites in United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Treace Medical Concepts, Inc.
Hallux Valgus
A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy
The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR 50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours (SPID48) to measure analgesic effect in Korean…
- Trial name
- NCT01516008
- Testing
- Tapentadol IR 50 mg, Tapentadol IR 75 mg
- Where
- 7 sites in South Korea
- Volunteers
- 353 people
- Sponsor
- Janssen Research & Development, LLC
Hallux Valgus
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows: To assess functional clinical score's evolution, To evaluate…
- Trial name
- NCT05523219
- Where
- France
- Volunteers
- 81 people
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
Hallux Rigidus, Hallux Limitus
Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®
The great toe is vital for normal, pain free ambulation. Decreased function associated with osteoarthritis of the first matatarsal phalangeal joint (MTP I) often called Hallux Rigidis or Hallux Limitus leading to a painful great…
- Conditions
- Hallux Rigidus, Hallux Limitus, Hallux Valgus, Osteoarthritis
- Trial name
- NCT01284985
- Where
- 4 sites in Czechia, Netherlands and 2 more
- Volunteers
- 60 people
- Sponsor
- Integra LifeSciences Services
Bunion, Hallux Valgus
Study of Postoperative Analgesia in Bunionectomy
After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.
- Trial name
- NCT00890682
- Testing
- SKY0402
- Where
- United States
- Volunteers
- 193 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Hallux Valgus
Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).
- Trial name
- NCT03846687
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Ipsen