Clinical trials: Arthroplasty Complications
Total Knee Arthroplasty (Postoperative Pain)
Phase 2B Study Assessing Pain Relief After Replacement of the Knee
The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty.
- Trial name
- SPARK2 (NCT06799845)
- Testing
- ATX101, bupivacaine hydrochloride
- Where
- 11 sites in United States
- Volunteers
- 226 people
- Sponsor
- Allay Therapeutics, Inc.
Knee Osteoarthritis, Bone; Deformity, Congenital
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations…
- Conditions
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure, Prosthesis-Related Infections
- Trial name
- COREV (NCT05113303)
- Testing
- Navigated Revision Total Knee Arthroplasty, Manual Revision Total Knee Arthroplasty
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Arthrodesis, Degenerative Arthritis
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation
The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.
- Conditions
- Arthrodesis, Degenerative Arthritis, Rheumatoid Arthritis, Complications; Arthroplasty, Mechanical
- Trial name
- NCT01366989
- Testing
- Radiographic evaluation of previously implanted patients
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Stryker Trauma and Extremities
Pain, Postoperative
Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.
- Trial name
- NCT01015235
- Testing
- KAI-1678, Ketorolac Tromethamine
- Where
- New Zealand
- Volunteers
- 90 people
- Sponsor
- KAI Pharmaceuticals
Postoperative Pain
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative…
- Trial name
- NCT00403234
- Testing
- Buprenorphine transdermal patch
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Purdue Pharma LP
Postoperative Pain
Pilot Study of the Efficacy and Safety of Q8003 in Patients Who Have Undergone Total Knee Arthroplasty or Total Hip Arthroplasty
This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in patients who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.
- Trial name
- NCT00818493
- Testing
- Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride), Percocet (oxycodone and acetaminophen)
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- QRxPharma Inc.
Postsurgical Pain
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
The objectives of this proof of concept study are to evaluate the safety and preventive analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee…
- Trial name
- NCT01731730
- Testing
- AYX1 Injection 110 mg, AYX1 Injection 330 mg
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- Adynxx, Inc.
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.
Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Revision Hip Prosthesis System in adult participants…
- Conditions
- Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint, Prostheses-related Infections, Joint Instability
- Trial name
- NCT07653295
- Testing
- Tıpmed™ Revision Hip Prosthesis System
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 35 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
Pain, Postoperative
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement.
- Trial name
- NCT00508495
- Testing
- Paracetamol (acetaminophen), Paracetamol 1% solution, 0.9% sodium chloride solution
- Where
- 8 sites in Hungary
- Volunteers
- 148 people
- Sponsor
- Baxter Healthcare Corporation
Postoperative Pain, Total Knee Replacement
Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System
The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg.
- Conditions
- Postoperative Pain, Total Knee Replacement, Total Knee Arthroplasty, Partial Knee Replacement
- Trial name
- NCT04341948
- Testing
- SPRINT Peripheral Nerve Stimulation (PNS) System
- Where
- 10 sites in United States
- Volunteers
- 56 people
- Sponsor
- SPR Therapeutics, Inc.
Postsurgical Pain
Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
Total knee arthroplasty is a surgical treatment which involves replacing the damaged articular cartilage of the knee joint with an artificial prosthetic in end-stage knee osteoarthritis.
- Trial name
- MP-TKA (NCT06202989)
- Testing
- Multiprofen-CC™ plus standard treatment
- Where
- Canada
- Volunteers
- 306 people
- Sponsor
- KAZM Pharmaceuticals 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.
Post-surgical Pain
Study to Evaluate Safety/Efficacy of a Single Preop Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee arthroplasty.
- Trial name
- NCT02807428
- Testing
- AYX1 Injection 660 mg/6 mL
- Where
- 9 sites in United States
- Volunteers
- 210 people
- Sponsor
- Adynxx, Inc.
Pain, Postoperative
Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Knee Replacement in Patients With High PCS Scores
This is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with a Pain Catastrophizing…
- Trial name
- NCT03797612
- Testing
- Brivoligide Injection 660 mg/6 mL
- Where
- 2 sites in United States
- Sponsor
- Adynxx, Inc.
Postoperative Pain
Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty
Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty
- Trial name
- TKA (NCT00485693)
- Testing
- Bupivacaine HCl, SKY0402
- Where
- 9 sites in United States, Czechia
- Volunteers
- 138 people
- Sponsor
- Pacira Pharmaceuticals, 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
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
Osteoarthritis, Rheumatoid Arthritis
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Post Traumatic Deformity
- Trial name
- NCT01542580
- Testing
- Vanguard SSK 360 with PS Bearing, Vanguard SSK 360 with PSC bearing, Vanguard DA 360
- Where
- 12 sites in United States, Belgium and 6 more
- Volunteers
- 255 people
- Sponsor
- Zimmer Biomet
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.