Safety and Effectiveness of the HIT Reverse HRS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorHip Innovation Technology

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Hip Innovation Technology Reverse Hip Replacement System
  • Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.

Treatment groups

288 Participants
are divided into 2 treatment groups

Sponsors and collaborators