Clinical trials: Bunion
Rotator Cuff Repair, Ankle Arthroplasty or Arthrodesis
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Pragmatic Clinical Trial
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.
- Conditions
- Rotator Cuff Repair, Ankle Arthroplasty or Arthrodesis, Hallux Valgus (Bunion) Resection
- Trial name
- NCT04713098
- Testing
- Peripheral Nerve Stimulation
- Where
- 6 sites in United States
- Volunteers
- 250 people
- Sponsor
- University of California, San Diego
Hallux Valgus and Bunion (Disorder), Morton Neuroma
Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery
Foot surgery is a painful surgery that is usually scheduled in outpatients. A good management of analgesia is the crucial point.
- Conditions
- Hallux Valgus and Bunion (Disorder), Morton Neuroma, Metatarsal Fracture, Ingrown Nail
- Trial name
- DISTIB (NCT03504462)
- Testing
- Specific block of medial and lateral plantar nerves
- Where
- France
- Volunteers
- 27 people
- Sponsor
- CMC Ambroise Paré
Bunions, Postoperative Pain
Dose-Escalation Study of HTX-034 Following Bunionectomy
This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl.
- Trial name
- NCT04398329
- Testing
- HTX-034 low dose, HTX-034 high dose, Luer lock applicator
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Heron Therapeutics
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.
Postoperative Pain
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in…
- Trial name
- NCT03295721
- Testing
- HTX-011, Bupivacaine HCl, Luer-lock applicator
- Where
- 15 sites in United States
- Volunteers
- 412 people
- Sponsor
- Heron Therapeutics
Postoperative Pain
Phase 2 Bunionectomy HTX-011 Administration Study
This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with…
- Trial name
- NCT03718039
- Testing
- HTX-011, Luer Lock applicator, Vial access device
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Heron Therapeutics
Postoperative Pain, Bunions
Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
- Trial name
- NCT02762929
- Testing
- HTX-011A, HTX-011B, HTX-002
- Where
- 5 sites in United States
- Volunteers
- 430 people
- Sponsor
- Heron Therapeutics
Lower Extremity Surgery, Bunion
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
- Conditions
- Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion
- Trial name
- STRIDE (NCT04518462)
- Testing
- Exparel, Bupivacaine Hydrochloride
- Where
- 5 sites in United States
- Volunteers
- 121 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Hallux Valgus and Bunion
Timing of Weight Bearing After Hallux Valgus Surgery
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.
- Trial name
- NCT03340415
- Testing
- Accelerated Rehabilitation plan
- Where
- Hong Kong
- Volunteers
- 53 people
- Sponsor
- North District Hospital
Foot and Ankle Surgeries, Bunion
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.
- Trial name
- NCT03653429
- Testing
- Tranexamic Acid, Normal saline
- Where
- 2 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Bunion, Pain
Intravenous Tapentadol in Post-Bunionectomy Pain
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
- Trial name
- NCT01435577
- Testing
- Tapentadol
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- Grünenthal GmbH
Bunion
Ketorolac Effects on Post-operative Pain and Bone Healing
This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies.
- Trial name
- NCT01133639
- Testing
- Ketorolac
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Beth Israel Deaconess Medical Center
Pain, Post-operative
Evaluation of N1539 Following Bunionectomy Surgery
The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
- Trial name
- NCT02675907
- Testing
- N1539
- Where
- 4 sites in United States
- Volunteers
- 201 people
- Sponsor
- Baudax Bio
Pain, Post-operative
Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery
The primary objective of this study is to evaluate the safety of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
- Trial name
- NCT02540265
- Testing
- N1539
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Baudax Bio
Bunion, Hallux Rigidus
Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
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…
- Trial name
- NCT02499575
- Testing
- 0.5% ropivacaine, Exparel
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- OhioHealth
Pain, Post-operative
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery
The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects…
- Trial name
- NCT02284243
- Testing
- Intranasal Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Baudax Bio
Hallux Limitus of Left Great Toe, Rheumatoid Arthritis
Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.
Foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants.
- Conditions
- Hallux Limitus of Left Great Toe, Rheumatoid Arthritis, Arthritis of 1st Metatarsophalangeal Joint, Osteoarthritis
- Trial name
- NCT02350881
- Testing
- Primus FGTI (Flexible Great toe Implant)
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Stryker Trauma and Extremities
Pain, Postoperative, Bunion
Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension
The primary objective of this study is to show the effectiveness of repeated doses of COV795 versus placebo, using the summed pain intensity difference over the first 48 hours in subjects with acute moderate to severe pain…
- Trial name
- NCT01484652
- Testing
- COV795
- Where
- 5 sites in United States
- Volunteers
- 329 people
- Sponsor
- Mallinckrodt
Pain, Post-operative
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute…
- Trial name
- NCT02169336
- Testing
- Intranasal Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 95 people
- Sponsor
- Baudax Bio
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.