Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05357378
Study type Interventional
Source Hip Innovation Technology
Contact George Diamantoni
Phone 1-866-832-4471
Email g.diamantoni@hit-irh.com
Status Recruiting
Phase N/A
Start date July 15, 2022
Completion date July 15, 2035

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05773261 - Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups N/A
Recruiting NCT05223777 - KINCISEā„¢ 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Withdrawn NCT02743208 - Evaluation of a Short Femoral Stem in Total Hip Arthroplasty N/A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