A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip System by Radiostereometric Analysis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. This study will document any device-related surgical or post-operative complications and adverse radiographic observations.
Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.
Detailed Description
The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has hip disease that requires a total hip arthroplasty.
- •Subject is willing to consent to participation in the study.
- •Subject plans to be available for follow-up through study duration.
- •Subject is of stable health and is free of or treated and stabilized for any condition that would prose excessive operating risk.
Exclusion Criteria
- •Subject has insufficient femoral bone stock.
- •Subject has had major non-arthroscopic surgery to the study hip.
- •Subject has physical, emotional or neurological conditions that would compromise the subjects compliance with postoperative rehabilitation and follow-up.
- •Subject has a known sensitivity to materials in the device.
Outcomes
Primary Outcomes
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)
Time Frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)
Time Frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.
Secondary Outcomes
- Preoperative Total Harris Hip Score (HHS)(Preoperative)
- 3 Months Postoperative Total Harris Hip Score (HHS)(3 months postoperative)
- 1 Year Postoperative Total Harris Hip Score (HHS)(1 year postoperative)
- 2 Years Postoperative Total Harris Hip Score (HHS)(2 years postoperative)
- Preoperative Radiographic Assessments(Preoperative)
- 3 Years Postoperative Total Harris Hip Score (HHS)(3 years postoperative)
- 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)(1 year postoperative)
- 5 Years Postoperative Radiographic Assessments(5 years postoperative)
- 5 Years Postoperative Total Harris Hip Score (HHS)(5 years postoperative)
- Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)(Preoperative)
- 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)(3 months postoperative)
- 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)(5 years postoperative)
- 3 Months Postoperative Radiographic Assessments(3 months postoperative)
- 1 Year Postoperative Radiographic Assessments(1 year postoperative)
- 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)(2 years postoperative)
- 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)(3 years postoperative)
- 2 Years Postoperative Radiographic Assessments(2 years postoperative)
- 3 Years Postoperative Radiographic Assessments(3 years postoperative)