Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty
ConditionOsteoarthritis of Hip
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-79
SponsorHip Innovation Technology
About this trial
To evaluate effectiveness and safety of HHRS in subjects undergoing total hip arthroplasty (THA). Effectiveness will be evaluated using patient-reported, clinical, radiologic, and radiostereometric outcomes. Safety will be evaluated through the collection of device-related and unanticipated device-related adverse events.
Eligibility criteria
Qualifiers
Patient has a non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary total hip replacement.
Age between 65 and 79 years (inclusive) at the time of enrollment.
Patient is a suitable candidate for primary total hip replacement at the discretion of the Investigator.
Pre-surgery (within 28 days before surgery) WOMAC Global Score of 40 or larger on a scale from 0 (best) to 96 (worst)
Disqualifiers
Patient has had total hip replacement, hemi-arthroplasty, or fusion in either hip in the last 12 months;
Patient has planned total hip arthroplasty on a contra-lateral joint in the next 12 months;
Patient has a known allergy to any component of the study device;
Patient has a history of active sepsis in the joint;
Trial design
Treatments tested in this trial
- HIT Hip Replacement System
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov