Clinical trials: Hallux Valgus (Bunions)
Hallux Valgus
Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.
- Trial name
- PECA (NCT05361317)
- Testing
- Nexis® PECA Bunion device
- Where
- 4 sites in France
- Volunteers
- 86 people
- Sponsor
- Novastep
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, 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.
Pain, Post-surgical
Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.
- Trial name
- NCT00653354
- Testing
- valdecoxib
- Where
- 21 sites in United States
- Volunteers
- 360 people
- Sponsor
- Pfizer
Hallux Valgus, Bunion
Early Weight-Bearing After the Lapiplasty Procedure
The objectives of this study are to evaluate the following outcomes of the Lapiplasty® Procedure for patients in need of hallux valgus surgery: The study will determine the radiographic recurrence of hallux valgus and the timing…
- Trial name
- ALIGN3D (NCT03740282)
- Testing
- Lapiplasty
- Where
- 7 sites in United States
- Volunteers
- 183 people
- Sponsor
- Treace Medical Concepts, Inc.
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
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
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
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
Arthrodesis, Bunion
Multi-Plane Hallux Valgus Correction With the Phantom® Nail
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…
- Conditions
- Arthrodesis, Bunion, Hallux Valgus
- Trial name
- NCT04084262
- Testing
- Intramedullary Nail
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Paragon 28
Arthralgia, Bunion
A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety.
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 3 different dose levels of CG5503 compared with oxycodone and with placebo in patients who have had a…
- Conditions
- Arthralgia, Bunion, Hallux Valgus, Pain Assessment
- Trial name
- NCT00364247
- Testing
- CG5503 IR;tapentadol
- Volunteers
- 602 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Arthralgia, Bunion
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have…
- Conditions
- Arthralgia, Bunion, Hallux Valgus, Pain
- Trial name
- NCT00613938
- Testing
- Tapentadol (CG5503), oxycodone
- Where
- 7 sites in United States
- Volunteers
- 901 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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