Osteoarthritis, Hip Clinical Trial
Official title:
Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study
The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.
This is a randomized, controlled, multi-center clinical trial. Subjects meeting inclusion and exclusion criteria will be recruited from patients undergoing primary THA at up to 20 investigational sites. Subjects in the Experimental Arm will receive the Investigational Device. Subjects in the Control Arm will receive one of the already-marketed semi- constrained uncemented hip systems using a metal-on-highly-cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination. The following hip systems will be eligible for subjects in the Control Arm: - DePuy Synthes Corail® Total Hip System in combination with Pinnacle® Complete Acetabular Hip System; - Zimmer Biomet Taperloc® Complete Hip System in combination with G7® Acetabular System; - Stryker Accolade® II femoral stem in combination with Stryker Trident® II acetabular cup; - Smith & Nephew Anthology® Total Hip System in combination with R3® Acetabular System. Surgery, post-surgical care, and rehabilitation will be per standard of care (SOC) for both arms. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05773261 -
Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups
|
N/A | |
| Recruiting |
NCT05223777 -
KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)
|
N/A | |
| Recruiting |
NCT04731077 -
Avenir Complete Post-Market Clinical Follow-Up Study
|
N/A | |
| Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
| Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
| Not yet recruiting |
NCT06162195 -
The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
|
N/A | |
| Withdrawn |
NCT02743208 -
Evaluation of a Short Femoral Stem in Total Hip Arthroplasty
|
N/A | |
| Completed |
NCT02944448 -
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
|
Phase 2 | |
| Active, not recruiting |
NCT02229279 -
Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures
|
N/A | |
| Active, not recruiting |
NCT02851992 -
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
|
N/A | |
| Completed |
NCT01700933 -
Dose-response: Exercise Therapy on Hip Osteoarthritis
|
N/A | |
| Completed |
NCT01618708 -
A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip
|
N/A | |
| Completed |
NCT01214954 -
Early Rehabilitation After Total Hip Replacement
|
N/A | |
| Active, not recruiting |
NCT00294424 -
Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements
|
N/A | |
| Terminated |
NCT00588861 -
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
|
N/A | |
| Withdrawn |
NCT05054595 -
Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
|
N/A | |
| Terminated |
NCT00973141 -
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
|
Phase 2 | |
| Recruiting |
NCT05014113 -
H-28 DELTA ST-C and Minima Retrospective Study.
|
||
| Completed |
NCT01066936 -
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
|
||
| Recruiting |
NCT05530551 -
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA
|
N/A |