Clinical trials: Valgus
Osteoarthritis, Traumatic Arthritis
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.
- Conditions
- Osteoarthritis, Traumatic Arthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus
- Trial name
- NCT00854295
- Testing
- NexGen LPS-Flex Mobile Bearing Knee
- Where
- 3 sites in United States
- Volunteers
- 266 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
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.
Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs
Safety and Performance of PEEK Anchors in Extremities
Safety and performance of the study devices in extremities up to 12 months post-surgery
- Conditions
- Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- NCT03782298
- Testing
- Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL
- Where
- 4 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis, Rheumatoid Arthritis
Persona TM Tibia Clinical Outcomes Study
The primary objective of this study is to evaluate clinical performance for the commercially available Persona TM Tibia used in primary cementless tibia total knee arthroplasty.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis
- Trial name
- NCT03589300
- Testing
- Persona TM Tibia
- Where
- 7 sites in United States
- Volunteers
- 148 people
- Sponsor
- Zimmer Biomet
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 to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo
The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain, compared with placebo, in adult Taiwanese patients…
- Trial name
- NCT01813890
- Testing
- Tapentadol IR 50 mg, Tapentadol IR 75 mg
- Where
- 3 sites in Taiwan
- Volunteers
- 60 people
- Sponsor
- Janssen-Cilag International NV
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 Abducto Valgus
Dysport in Hallux Abducto Valgus (HAV) Phase IIa
The purpose of this study is to investigate the efficacy and safety of treatment with multiple doses of Dysport in adults suffering from clinically significant pain associated with HAV who have not undergone surgery for their…
- Trial name
- DYSTANCE (NCT03569098)
- Testing
- Botulinum toxin type A
- Where
- 29 sites in United States
- Volunteers
- 186 people
- Sponsor
- Ipsen
Knee Pain, Chronic Osteoarthritis
ROSA Total Knee Post Market Study EMEA
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data.
- Conditions
- Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities
- Trial name
- NCT04338893
- Testing
- Device: Persona Total Knee, Device: NexGen Total Knee, Device: Vanguard Total Knee
- Where
- 6 sites in Belgium, Germany and 3 more
- Volunteers
- 252 people
- Sponsor
- Zimmer Biomet
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
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 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 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
Osteoarthritis, Rheumatoid Arthritis
NexGen TM Tibia Clinical Outcomes Study
The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis
- Trial name
- NCT03272373
- Testing
- NexGen TM Monoblock Tibia, NexGen TM Modular Tibia
- Where
- 7 sites in United States
- Volunteers
- 160 people
- Sponsor
- Zimmer Biomet
Knee Pain, Chronic Osteoarthritis
ROSA Robot Used in Total Knee Replacement Post Market Study
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data.
- Conditions
- Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities
- Trial name
- NCT03969654
- Testing
- PERSONA Total Knee, Vanguard Total Knee, NexGen Total Knee
- Where
- 5 sites in United States
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
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