Clinical trials: Complications; Arthroplasty
Post-Operative Pain
Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Postoperative Pain Following Total Hip Arthroplasty.
The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, and placebo-controlled study.
- Trial name
- NCT03347266
- Testing
- VVZ-149 injections
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Vivozon, Inc.
Acute Postoperative Pain
Study Assessing Pain Relief After Replacement of the Knee
This is a Phase 2B randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty.
- Trial name
- SPARK (NCT05260008)
- Testing
- ATX-101, bupivacaine hydrochloride without epinephrine
- Where
- 13 sites in Australia, Canada and 1 more
- Volunteers
- 112 people
- Sponsor
- Allay Therapeutics, Inc.
Osteoarthritis of Knee, Edema
Microcurrent Stimulation Reduces Post-Operative Swelling and Healing Time Following Knee Replacement Surgery
The purpose of this study is to determine if patients undergoing a total knee arthroplasty (TKA) experience a clinically significant reduction in healing time when treated post operatively with a specific form of micro and…
- Conditions
- Osteoarthritis of Knee, Edema, Wounds and Injuries
- Trial name
- NCT02623660
- Testing
- ODIN1, Standard Care, Diagnostic Device Testing
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bioelectric Research Corporation
Surgical Wound, Revision Total Knee Arthroplasty
Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care…
- Conditions
- Surgical Wound, Revision Total Knee Arthroplasty, Wounds and Injuries, Joint Disease
- Trial name
- PROMISES (NCT03274466)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
- Where
- 17 sites in United States
- Volunteers
- 294 people
- Sponsor
- KCI USA, Inc
Osteoarthritis, Postoperative Pain
Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.
- Trial name
- NCT00442546
- Testing
- pregabalin
- Where
- 27 sites in United States
- Volunteers
- 307 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Opioid Use, Arthropathy of Knee
RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA).
- Conditions
- Opioid Use, Arthropathy of Knee, Pain, Postoperative
- Trial name
- NCT04010266
- Testing
- RelieVRx headset, multi-modality pain management
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- AppliedVR Inc.
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Wound Heal
Performance, Safety and Efficacy of PICO Device.
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the…
- Trial name
- NCT03698968
- Testing
- Negative Pressure Wound Therapy
- Where
- 11 sites in Switzerland, United Kingdom
- Volunteers
- 50 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis
The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty
The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a…
- Trial name
- TC3 (NCT00733681)
- Testing
- PFC Sigma RP TC3 Revision knee system
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 181 people
- Sponsor
- DePuy International
Post Operative Pain
OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty
The purpose of this study is to demonstrate that treatment with OXN PR tablets is non inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with postoperative pain after knee arthroplasty based on…
- Trial name
- OXN4505 (NCT01083485)
- Testing
- Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets, Oxycodone
- Where
- Finland
- Volunteers
- 137 people
- Sponsor
- Mundipharma Oy
Osteoarthritis, Avascular Necrosis
Arcos Revision Stem: Evaluation of Clinical Performance
The primary purpose of this study is to evaluate the clinical performance of the Arcos Revision Stem system, determine the stability of the implants, and evaluate any relationship between Paprosky bone defect level and the…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Deformity
- Trial name
- NCT01820611
- Testing
- Arcos Revision Stem System
- Where
- 5 sites in Finland, Spain and 2 more
- Volunteers
- 74 people
- Sponsor
- Zimmer Biomet
Postoperative Pain
Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty
The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral…
- Trial name
- NCT01683071
- Testing
- EXPAREL 67 mg, EXPAREL 133 mg, EXPAREL 266 mg
- Where
- 30 sites in United States
- Volunteers
- 297 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Postoperative Pain
Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and…
- Trial name
- NCT03015532
- Testing
- HTX-011, Bupivicaine HCl, Ropivacaine
- Where
- 24 sites in United States
- Volunteers
- 285 people
- Sponsor
- Heron Therapeutics
Total Knee Arthroplasty, Total Hip Arthroplasty Revision
Interventional Study Exploring the Occurrence of Surgical Site Infections.
Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT.
- Conditions
- Total Knee Arthroplasty, Total Hip Arthroplasty Revision, Total Knee Arthroplasty Revision
- Trial name
- NCT06661473
- Testing
- Avance Solo Negative Pressure Wound Therapy
- Where
- 8 sites in United States
- Volunteers
- 104 people
- Sponsor
- Molnlycke Health Care AB
Postoperative Pain
A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty
The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.
- Trial name
- TKA (NCT00745290)
- Testing
- Bupivacaine HCl, SKY0402
- Where
- 19 sites in United States
- Volunteers
- 245 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Osteoarthritis, Avascular Necrosis
Fitmore Hip Stem PMCF Study: A Multi-centre, Non-comparative, Prospective Post-market Clinical Follow-up Study.
A multi-centre, non-comparative, prospective post-market clinical follow-up study to obtain survival, clinical and radiographic outcomes data on the Zimmer Fitmore Hip Stem.
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Prosthesis Failure
- Trial name
- NCT03411044
- Testing
- Fitmore Hip Stem
- Where
- 5 sites in Germany, Italy and 2 more
- Volunteers
- 420 people
- Sponsor
- Zimmer Biomet
Osteo Arthritis Shoulders
Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.
- Trial name
- NCT03782675
- Testing
- Control, Air Barrier System
- Volunteers
- 40 people
- Sponsor
- Nimbic Systems, LLC
Pain, Postoperative
A Phase I Dose-escalation Study of a Single Administration of Extended-Release Injectable Suspension (ND-340)
This study focused on ND-340 extended release injection suspension for patients undergoing total knee arthroplasty with a one-time nerve blockade to assess drug side effects, pharmacokinetics and the effect of pain relief after…
- Trial name
- NCT04515953
- Testing
- ND-340, IV-PCA
- Where
- Taiwan
- Volunteers
- 36 people
- Sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
Osteoarthritis, Traumatic Arthritis
A Clinical Investigation of the Vanguard™ Complete Knee System
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
- Conditions
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Lower Limb Deformity
- Trial name
- NCT00698854
- Testing
- Vanguard™ Complete Knee System, Vanguard™ Patient-Specific Femur
- Where
- 8 sites in United States
- Volunteers
- 552 people
- Sponsor
- Zimmer Biomet
Acute Pain, Postoperative
Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain
The purpose of this study is to compare intravenous (IV) and oral acetaminophen for the treatment of acute moderate to severe pain in combination with standard patient-controlled analgesia (PCA) in adult subjects following total…
- Trial name
- NCT02746263
- Testing
- IV acetaminophen, Oral acetaminophen, Morphine
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Mallinckrodt