Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty ((HRS-P))
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|ClinicalTrials.gov Identifier: NCT02836262|
Recruitment Status : Suspended (To investigate instrumentation concerns)
First Posted : July 18, 2016
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of Hip||Device: HIT Hip Replacement System||Not Applicable|
The HIT Hip Replacement System (HHRS) is a Metal-on-Polyethylene (MoP) conventional hip prosthesis. The HHRS consists of a femoral stem, an acetabular cup and a Cobalt Chromium Molybdenum (CoCrMo) ball that articulates within a polyethylene liner. The ball sits on the acetabular cup, and the polyethylene liner is attached to the femoral cup, which attaches to the femoral stem, instead of the acetabular cup. The acetabular component of the HHRS consists of a hemispherical acetabular shell with a clustered screw-hole design. The outside of the shells are coated with titanium plasma to facilitate bone in-growth and provide secure intermediate fixation with the prepared bone surface at the site of implantation. The acetabular cup has a 3-hole design that accommodates three titanium alloy bone screws. Inside the acetabular cup is a male taper for assembly with the acetabular ball. The femoral component consists of a femoral stem manufactured from titanium and a mating cobalt chrome femoral cup lined with a highly cross-linked ultra-high-molecular-weight polyethylene (UHMWPE). As with the acetabular cup, the femoral stem is porous coated using a plasma spray of pure titanium, which is intended to facilitate bone in-growth and provide secure intermediate fixation with the prepared bone surface at the site of implantation. The femoral stem incorporates a female taper for assembly with the male taper of the femoral cup.
The device has undergone extensive pre-clinical testing. There is no clinical experience with the HRS.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Prospective Study of the Hip Innovation Technology (HIT) Hip Replacement System in Primary Total Hip Arthroplasty|
|Actual Study Start Date :||August 25, 2017|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2026|
Experimental: HIT Hip Replacement System (HRS)
Single group assignment with historical controls.
Device: HIT Hip Replacement System
HIT Hip Replacement System
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) v3.0 Likert Scale Functional Limitations Score between baseline (pre-operative) and the 730- day post-operative follow-up time point. [ Time Frame: between pre-operative and 730 days (24 months) ]
- Change in Harris Hip Score between baseline (pre-operative) and the 730-day post-operative follow-up time point. [ Time Frame: between pre-operative and 730 days (24 months) ]
- Change in Oxford Hip Score between 730-day post-operative and baseline (pre-surgery) [ Time Frame: between 730-days post-operative and baseline (pre-surgery) ]
- Change in Short Form 36 v2 Physical Component Score (PCS) between 730-days post-operative and baseline (pre-surgery) [ Time Frame: between 730-days post-operative and baseline (pre-surgery) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836262
|Orthopaedic Innovation Centre|
|Winnipeg, Manitoba, Canada, R2K 2M9|
|Principal Investigator:||Thomas Turgeon, MD||Orthopaedic Innovation Centre|
|Study Director:||Branko Kopjar||Nor Consult, LLC|