Clinical trials: Osteotomy
Postoperative Pain, Bunion
Phase 3 Bunionectomy Study
Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.
- Trial name
- NCT07490496
- Testing
- CPL-01
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Cali Pharmaceuticals LLC
Arthroscopy, Bunionectomy
A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures
The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures.
- Conditions
- Arthroscopy, Bunionectomy, Osteotomy, Carpal Tunnel
- Trial name
- NCT00209560
- Testing
- fospropofol disodium
- Volunteers
- 168 people
- Sponsor
- Eisai Inc.
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
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.
Cancellous Bone Bleeding
A Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding
The purpose of this European study is to demonstrate the safety and performance of the SurgiClot® dressing in the treatment of cancellous bone bleeding.
- Trial name
- NCT02509208
- Testing
- SurgiClot haemostatic dressing
- Where
- 8 sites in Norway, United Kingdom
- Volunteers
- 30 people
- Sponsor
- St. Teresa Medical
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.
Degenerative Arthritis, Knee Osteoarthritis
Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients.
The purpose of this study is to evaluate the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the…
- Trial name
- NCT03000712
- Testing
- Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml
- Where
- South Korea
- Volunteers
- 26 people
- Sponsor
- R-Bio
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
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.
Hallux Valgus and Bunion
Post-Operative Pain and Opioid Reduction Trial After Bunionectomy
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.
- Trial name
- MERIT-2 (NCT05411861)
- Testing
- Analgesic Non Narcotic
- Where
- 3 sites in United States
- Volunteers
- 73 people
- Sponsor
- Cali Pharmaceuticals LLC
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
Fused Vertebrae, Ankylosing Spondylitis
Clinical Investigation of MONTAGE in Adults With Spinal Deformity Undergoing Pedicle Subtraction Osteotomy
This study evaluates the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE Settable Resorbable Hemostatic Bone Putty and standard of care (no bone hemostat) during pedicle subtraction osteotomy…
- Conditions
- Fused Vertebrae, Ankylosing Spondylitis, Sagittal Deformities, Thoracolumbar Kyphosis
- Trial name
- NCT04125147
- Testing
- Experimental: Montage Bone Hemostat
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Abyrx, 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
Total Knee Arthroplasty
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
- Trial name
- NCT03292003
- Testing
- Journey II BCS Total Knee System
- Where
- 12 sites in United States, Belgium and 1 more
- Volunteers
- 1,694 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Foot and Ankle Disorders, Ankle Fusion, Osteotomy
Burst Biologics Foot and Ankle Registry
This prospective registry was designed as an observational study to ascertain how commercially available Burst Products are being used by foot and ankle surgeons performing procedures which involve bone grafting, as well as…
- Trial name
- NCT03077256
- Testing
- BioBurst Fluid, Burst Allograft
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Burst Biologics
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, Knee, Rheumatoid Arthritis
Vanguard Rocc Post Market Surveillance
The objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the Vanguard Rocc knee prosthesis.
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis, Traumatic Arthritis, Posttraumatic Deformity
- Trial name
- NCT03664791
- Testing
- Vanguard Rocc
- Where
- 9 sites in Belgium, Denmark and 2 more
- Volunteers
- 450 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Knee, Osteonecrosis
Treatment of Medial Compartmental Osteoarthritis Grade 1-4 With TomoFix™ Small or Conservatively
The primary objective of this prospective multicenter study is to assess whether the functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental…
- Trial name
- NCT01048710
- Testing
- No intervention
- Where
- Japan
- Volunteers
- 148 people
- Sponsor
- Synthes GmbH
Medial Malleolus Fracture, Lisfranc Injury
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations…
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture
- Trial name
- NCT05555459
- Testing
- Operation
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Inion Oy
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet