Clinical trials: Orthopaedic Injuries
Aseptic Loosening, Infection
Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.
- Conditions
- Aseptic Loosening, Infection, Bone Loss, MCL - Medial Collateral Ligament Rupture of the Knee
- Trial name
- NCT03312088
- Testing
- Freedom Knee PCK Components
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Maxx Orthopedics Inc
Fractures, Bone, Nonunion of Fracture
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union…
- Conditions
- Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited
- Trial name
- NCT04299022
- Testing
- Vivigen Cellular Bone Matrix
- Where
- 4 sites in United States
- Volunteers
- 250 people
- Sponsor
- LifeNet Health
Meniscus Tears, Loose Bodies
Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee
The purpose of the study is to accumulate efficacy data on VisionScope Imaging (VSI) for pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage injuries).
- Conditions
- Meniscus Tears, Loose Bodies, Articular Osteoarthritis, Articular or Capsular Trauma
- Trial name
- VSI-001 (NCT01695720)
- Testing
- VisionScope Imaging (VSI) Exam
- Where
- 7 sites in United States
- Volunteers
- 105 people
- Sponsor
- VisionScope Technologies
Bacterial Infection
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware.
- Trial name
- NCT02436876
- Testing
- MBN-101
- Where
- 6 sites in United States
- Volunteers
- 29 people
- Sponsor
- Microbion Corporation
Femoral Fractures
Observational Retrospective and Prospective Study on the Treatment of Femoral Fractures With EBA2
This is an observational, retrospective and prospective study where subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be followed for data collection since the day before…
- Trial name
- NCT01599221
- Testing
- EBA2
- Where
- 3 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Citieffe S.r.l
Orthopedic Trauma Wounds
Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy
The purpose of this study is to determine the effect of NanoDOX™ Hydrogel in conjunction with serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and soft tissue wounds when compared to a…
- Trial name
- NCT01518491
- Testing
- NanoDOX Hydrogel, VAC Alone
- Where
- 2 sites in United States
- Sponsor
- NanoSHIFT LLC
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
Tibial Fractures
Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
Case series of tibial plateau fractures using Norian Drillable.
- Trial name
- NCT01132508
- Testing
- Norian Drillable Bone Void Filler
- Where
- 6 sites in Australia, China and 2 more
- Volunteers
- 33 people
- Sponsor
- Synthes GmbH
Osteoarthritis (OA), Longevity
Registry of Outcomes of Dezawa MuseCells®
The goal of this observational study is to learn about the long-term effects of Dezawa MuseCells to treat various diseases. The Primary Goal: What is the short-term and long- term outcomes of Dezawa Musecells? Participants…
- Conditions
- Osteoarthritis (OA), Longevity, Wound Care, Pain
- Trial name
- NCT07645989
- Testing
- MuseCell Treatment
- Where
- 2 sites in United States, Mexico
- Volunteers
- 5,000 people
- Sponsor
- MuseCell Innovations Pte LTD
Orthopedic Disorders, Surgical Site Infection
Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial
Surgical site infections are a major postoperative complication and are mostly due to colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or Propionibacterium acnes.
- Trial name
- DECO-SSI (NCT02560155)
- Testing
- Mupirocin 2% nasal ointement, Chlorhexidine sol 4%
- Where
- Switzerland
- Volunteers
- 1,300 people
- Sponsor
- Lindenhofgruppe AG
Surgical Site Infection (SSI)
Sterile vs Clean Non-Sterile Wound Dressing in Orthopedic Surgery
This randomized interventional pilot study aims to compare the rate of significant Surgical Site Infection (SSI) within the six weeks after elective orthopedic surgery using sterile versus clean non-sterile glove postoperative…
- Trial name
- NCT07436065
- Testing
- Sterile Glove Dressing Technique, Clean Non-Sterile Glove Dressing Technique
- Where
- Qatar
- Volunteers
- 25 people
- Sponsor
- Hamad Medical Corporation
Spinal Fractures, Vertebral Compression Fractures
SpineJack® Versus Conservative Treatment Study (SPICO Study)
This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows: 1. SpineJack® system 2.
- Conditions
- Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Trauma
- Trial name
- NCT02657265
- Testing
- SpineJack system, Conservative management
- Where
- 9 sites in France
- Volunteers
- 100 people
- Sponsor
- Vexim SA
Staphylococcus Aureus, Orthopaedic Surgery
Preoperative Decolonization and Surgical Site Infections in Orthopaedic Surgery - 2 Year Outcome in Prosthetic Surgery
Surgical site infections in orthopaedic surgery are a major problem. Decolonization has been suggested to reduce infection rates.
- Conditions
- Staphylococcus Aureus, Orthopaedic Surgery, Surgical Site Infection, Prevention
- Trial name
- DECO-SSI (NCT03962907)
- Testing
- Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun, BACTROBAN® Nasal ong
- Where
- Switzerland
- Volunteers
- 1,318 people
- Sponsor
- Lindenhofgruppe AG
Long Bone Non-Union
Study on Autologous Osteoblastic Cells Implantation in Hypotrophic Non-Union Fractures
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003).
- Trial name
- NCT01756326
- Testing
- PREOB® Implantation, Bone Autograft
- Where
- 16 sites in Belgium, France and 1 more
- Volunteers
- 5 people
- Sponsor
- Bone Therapeutics S.A
Infection of Total Knee Joint Prosthesis
Evaluating Bactisure Wound Lavage in Orthopedic Wounds
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.
- Trial name
- NCT03192124
- Testing
- Bactisure
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zimmer Biomet
Orthopedic Disorder, Wound
Registry of Amniotic Membrane: Evaluating Utilization and Outcomes in Various Applications
This registry will assess clinical outcomes following the use of Cryopreserved Amniotic Membrane (CAM) for the treatment of orthopedic and various other conditions.
- Trial name
- NCT04222166
- Testing
- CAM
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- MED Institute Inc.
Fractures, Open, Fractures, Closed
LOQTEQ® Antibacterial Pre-Market Study
aap001 is a randomized, controlled, subject-blinded, multi-center study to show the safety of the LOQTEQ® antibacterial silver-coated system is non-inferior in comparison with the uncoated LOQTEQ® system
- Conditions
- Fractures, Open, Fractures, Closed, Surgical Site Infection, Fracture of Fibula
- Trial name
- NCT05260463
- Testing
- Implantation
- Where
- 13 sites in Germany
- Volunteers
- 203 people
- Sponsor
- aap Implantate AG
Surgical Wound
Regenn® Therapy System Safety Study
The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical…
- Trial name
- NCT06259409
- Testing
- Regenn® Negative Pressure Therapy System, Prevena™ Incision Management System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Progenerative Medical, Inc
Orthopedic Disorder, Trauma Injury
X-BS Ortho Bone Graft Study
Randomised investigation of the osteoconductive performance and safety of CE-marked FDBS bone graft (GraftR3®), with contextual reference to CE-marked IBS (MBCP® Putty), in the filling of orthopaedic bone defects.
- Conditions
- Orthopedic Disorder, Trauma Injury, Extremity Injury
- Trial name
- NCT06326827
- Testing
- FDBS (GraftR3®), IBS (MBCP® Putty)
- Volunteers
- 200 people
- Sponsor
- Advanced Medical Solutions Ltd.
Pain, Postoperative
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.
- Trial name
- NCT00709436
- Testing
- PMI-150 (intranasal ketamine)
- Where
- 16 sites in United States
- Volunteers
- 250 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer