Clinical trials: Osteotomies
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.
Acute Pain
Bunionectomy Study (0000-063)
We are interested in whether bunionectomy can be used as a model to study the treatment of acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS) medications (such as ibuprofen) and other…
- Trial name
- NCT00601458
- Testing
- pregabalin, naproxen sodium
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Primary Osteoarthritis, Post-Traumatic Arthritis
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Arthritis, Inflammatory Joint Disease, Femoral Neck Fracture
- Trial name
- NCT03357445
- Testing
- Avantage Reload cup
- Where
- 4 sites in France, Slovenia
- Volunteers
- 500 people
- Sponsor
- Zimmer Biomet
Knee Deformity
Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy
The aim of this study is to obtain performance and safety data of the new investigational device, dual-part Adaptos®Ortho Wedge, for its intended use in orthopaedic surgery.
- Trial name
- NCT05570760
- Testing
- Adaptos®Ortho Wedge (bone grafting surgery), OWHTO without bone grafting, chronOS® Wedge (bone grafting surgery)
- Where
- 6 sites in Finland, Hungary
- Volunteers
- 87 people
- Sponsor
- Biomendex Oy
Abnormalities, Jaw, Malocclusion, Angle Class III
First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies
The study product is a Cold Ablation Robot-guided Laser Osteotome (CARLO®) robotic surgery device. It is a device that removes hard tissue such as bone by means laser ablation - it is therefore an alternative to Piezo-Electric…
- Trial name
- NCT03901209
- Testing
- Mid-face osteotomy
- Where
- 4 sites in Austria, Germany and 1 more
- Volunteers
- 31 people
- Sponsor
- Advanced Osteotomy Tools (AOT) AG
Osteoarthritis, Varus Malalignment
Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy
The purpose of this study is to assess whether there is a difference between the TomoFix and Ellipse Intramedullary HTO Nail System in terms of bone regeneration in the tibial wedge by performing a CT-scan at 3 and 6-months…
- Trial name
- CISKO (NCT03431662)
- Testing
- Ellipse IM HTO Nail, TomoFix
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Ellipse Technologies, Inc.
Hallux Valgus, Hallux Varus
Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy may be more indicated than the distal osteotomy as it allows to achieve a greater degree of correction.
- Conditions
- Hallux Valgus, Hallux Varus, Vicious Callus on M1
- Trial name
- NCT01284998
- Where
- 3 sites in France, Lebanon and 1 more
- Volunteers
- 85 people
- Sponsor
- Integra LifeSciences Services
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
Femur Fracture, Osteotomy
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical…
- Trial name
- NCT05339360
- Testing
- Femoral fixation with intramedullary nails
- Where
- 2 sites in Spain, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Unicompartmental Medial Knee Osteoarthritis
TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation
This preliminary pilot study is a single-centre, prospective, uncontrolled, 32-month study to assess the performance of personalised opening wedge High Tibial Osteotomy (HTO) treatment using the TOKA® device and procedure.
- Trial name
- TOKA (NCT04574570)
- Testing
- High Tibial Osteotomy
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- 3D Metal Printing Ltd
Hammertoe, Hammer Toe Syndrome
Mg Alloy DrillPins in Hammertoe Deformity Correction
This is a prospective, single-arm clinical feasibility study evaluating the safe application of a novel lean absorbable magnesium-zinc-calcium alloy (ZX00) drill pin (RemeOs™ DrillPin) for the surgical correction of hammertoe…
- Trial name
- NCT07121790
- Testing
- Implant Mg-based RemeOs™ drillpins
- Volunteers
- 20 people
- Sponsor
- Bioretec Ltd.
Flat Foot, Lateral Column Lengthening
Evaluation of the Titan 3-D™ Wedge System
Evaluate clinical healing and radiographic maintenance of correction following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge.
- Conditions
- Flat Foot, Lateral Column Lengthening, Medial Cuneiform Osteotomy
- Trial name
- NCT03421665
- Testing
- Titan 3D Wedge System
- Sponsor
- Paragon 28
Osteoarthritis, Varus Malalignment
Ellipse Intramedullary High Tibial Osteotomy Nail Study
The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.
- Trial name
- NCT02519218
- Testing
- Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System
- Volunteers
- 6 people
- Sponsor
- Ellipse Technologies, Inc.
Osteoarthritis, Knee
Assessment of HydroxyColl Bone Graft Substitute in High Tibial Osteotomy Wedge Grafting.
The overall goal of this study is to demonstrate the safety and efficacy of Hydroxycoll bone graft substitute when used in the treatment of patients undergoing surgical treatment for varus mis-alignment in medial unicompartmental…
- Trial name
- HColl_HTO (NCT03601130)
- Testing
- HydroxyColl Bone Graft Substitute, DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- SurgaColl Technologies Limited
Knee Osteoarthritis
The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients
The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal tibial osteotomy in treatment of knee osteoarthritis patients.
- Trial name
- NCT01267214
- Testing
- Sodium Hyaluronate (Hyalgan), Osteotomy alone
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- TRB Chemedica
Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip
Avenir® Cemented Hip Stem - PMCF
The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip, Femoral Neck Fractures, Femoral Head Necrosis
- Trial name
- NCT03396224
- Where
- 3 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Body Contouring Surgery
RIBOSS-01: Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing
The goal of this observational study is to learn about the long-term effects of RIBOSS intervention and demonstrate non-inferiority of postoperative respiratory function (FEV1, FVC, FEV1/FVC) at 6 months in the RIBOSS group…
- Trial name
- (RIBOSS) (NCT07705295)
- Where
- Colombia
- Volunteers
- 160 people
- Sponsor
- Research Inc
Distal Radius Fracture, Distal Ulna Fracture
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates.
- Conditions
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- Trial name
- NCT04653051
- Where
- United Kingdom
- Volunteers
- 111 people
- Sponsor
- Zimmer Biomet
Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee, Unilateral Post-Traumatic Osteoarthritis of Knee
JOURNEY II XR Safety and Effectiveness PMCF
This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis.
- Conditions
- Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee, Unilateral Post-Traumatic Osteoarthritis of Knee, Knee Osteoarthritis, Degenerative Arthritis Peripheral Joint
- Trial name
- NCT03136887
- Testing
- JOURNEY II XR Total Knee System
- Where
- 14 sites in United States
- Volunteers
- 176 people
- Sponsor
- Smith & Nephew, Inc.