NCT02836262 Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty
| NCT ID | NCT02836262 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hip Innovation Technology |
| Condition | Osteoarthritis of Hip |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-08-25 |
| Primary Completion | 2025-08-25 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Inclusion Criteria: * 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) * Signed and dated informed consent document. * 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 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-later