Clinical trials: Joint Arthrodesis
Arthritis
Post Market Clinical Follow-Up KeriFuse®
The general objective of this study is to evaluate the performances and the safety related to the KeriFuse® intramedullary arthrodesis implant and associated instrumentation used in accordance with their approved labelling and…
- Trial name
- NCT06546332
- Testing
- KeriFuse®
- Where
- 6 sites in France
- Volunteers
- 97 people
- Sponsor
- Keri Medical SA
Foot Deformities
Bone Healing Accelerant (BHA) Versus Autologous Bone Grafting (ABG) for Hindfoot or Ankle Arthrodesis
This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle…
- Trial name
- NCT06258499
- Testing
- BHA
- Sponsor
- Carmell Therapeutics Corporation
Sacroiliac Joint Dysfunction, Sacroiliac; Fusion
Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion
This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
- Trial name
- RELIEF (NCT06487936)
- Testing
- TransLoc 3D SI Joint Fusion System
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- CornerLoc
Spinal Disease
ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP
This study is designed as a post-marketing observational, controlled, prospective, non-inferiority study where the efficacy and safety of the Degenerative Disc Disease treatment by arthrodesis using…
- Trial name
- ROMEO 2 PAD FR (NCT04174534)
- Where
- 3 sites in France
- Volunteers
- 3 people
- Sponsor
- Spineart SA
Degenerative Sacroiliitis, Sacroiliac Joint Disruption
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint).
- Trial name
- SIFI (NCT01640353)
- Where
- 26 sites in United States
- Volunteers
- 194 people
- Sponsor
- SI-BONE, Inc.
Bone Disease, Fracture Bone
Calcium Phosphate Cement Registry (CPC Registry)
CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults.
- Conditions
- Bone Disease, Fracture Bone, Bone Cyst
- Trial name
- CPC (NCT02575352)
- Where
- 11 sites in France, Germany and 3 more
- Volunteers
- 500 people
- Sponsor
- Graftys SA
Ulnar/Radial Collateral Ligament Reconstruction, Ligament Repair or Reconstruction
Registry of Arthrex Hand and Wrist Products
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
- Conditions
- Ulnar/Radial Collateral Ligament Reconstruction, Ligament Repair or Reconstruction, Small Bone Fragments and Arthrodesis, Scapholunate Ligament Reconstruction
- Trial name
- NCT05046600
- Testing
- Products listed in cohort description
- Where
- 5 sites in United States
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- Arthrex, Inc.
Arthrodesis Surgery Involving the Hindfoot or Ankle
AMPLEX Ankle Fusion and Hindfoot
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.
- Trial name
- NCT03028415
- Testing
- AMPLEX, Autogenous Bone Graft (ABG)
- Where
- 36 sites in United States, Canada
- Volunteers
- 56 people
- Sponsor
- Ferring Pharmaceuticals
First Metatarsophalangeal Joint Arthritis
Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis
This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \and hardware complications.
- Trial name
- NCT03290586
- Testing
- Flower Cube
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- JEM Research Institute
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
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of…
- Conditions
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle
- Trial name
- NCT04715139
- Testing
- Products listed in Group/Cohort Description
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Arthrex, Inc.
Ankle and Hindfoot Arthrodesis
Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft
The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft.
- Trial name
- NCT03998137
- Testing
- AUGMENT® Injectable Bone Graft, Standard of Care
- Volunteers
- 94 people
- Sponsor
- BioMimetic Therapeutics
Fracture;Pelvis, Sacral Fracture
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
- Conditions
- Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion, Fragility Fracture
- Trial name
- SAFFRON (NCT05426356)
- Testing
- Surgical Intervention, Non-Surgical Management
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- SI-BONE, Inc.
Sacro Iliac Joint Pain, Sacro-iliac Joints
Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes
The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.
- Conditions
- Sacro Iliac Joint Pain, Sacro-iliac Joints, Sacroiliac Disorder, Sacroiliac Joint Dysfunction
- Trial name
- PIERCE (NCT07565545)
- Testing
- iFuse INTRA Ti Implant System
- Volunteers
- 120 people
- Sponsor
- SI-BONE, Inc.
Arthritis
Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis
In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is…
- Trial name
- NCT02025946
- Where
- 8 sites in Belgium, France and 5 more
- Sponsor
- Integra LifeSciences Services
Arthrodesis
Follow-up of Patient Implanted With the Staple ASTUS®
There are many ways of performing arthrodesis in the foot and ankle. Dowel fusion is one of them. The in situ technique was first described by Ottolenghi et al. (1970) and was taken up by Baciu and Filibiu (1979).
- Trial name
- NCT01518543
- Where
- 2 sites in Ireland, United Kingdom
- Volunteers
- 5 people
- Sponsor
- Integra LifeSciences Services
Hallux Valgus, Bunion
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery.
- Trial name
- Mini3D (NCT05082012)
- Testing
- Treatment of Hallux Valgus
- Where
- 10 sites in United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Treace Medical Concepts, Inc.
Sacroiliitis
CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System
This study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry).
- Trial name
- NCT02425631
- Testing
- SImmetry Sacroiliac Joint Fusion System
- Volunteers
- 19 people
- Sponsor
- Zyga Technology, 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
Degenerative Joint Disease, Congenital Deformity
Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
STUDY OBJECTIVES: To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions) STUDY HYPOTHESIS: Augment® Injectable is an equivalent…
- Conditions
- Degenerative Joint Disease, Congenital Deformity, Arthritis, Osteoarthritis
- Trial name
- NCT01305356
- Testing
- Augment® Injectable Bone Graft, Autologous bone graft
- Where
- 25 sites in United States, Canada
- Volunteers
- 299 people
- Sponsor
- BioMimetic Therapeutics