Safety and Effectiveness of the HIT Reverse HRS (NCT05357378) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Effectiveness of the HIT Reverse HRS
United States288 participantsStarted 2022-07-15
Plain-language 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.
Who can participate
Age range50 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patient requires primary THA due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary THA.
* Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment.
* Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk.
* Patient has a signed and dated Informed Consent Form (ICF).
* Patient is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.
Exclusion Criteria:
* Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months.
* Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-10.
* Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months.
* Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months.
* Patient has a known allergy to titanium and/or XLPE.
* Patient has known metal sensitivities to cobalt chromium (CoCr).
* Patient has a history of septic arthritis in the index joint.
* Patient has insufficient acetabula…
What they're measuring
1
OHS of 36 or more at the 2-year follow-up visit
Timeframe: 24 months
2
Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline.