Mini Stem Radiostereometric Analysis Study
This trial is active, not recruiting.
|Sponsor||Smith & Nephew, Inc.|
|Start date||June 2009|
|End date||August 2016|
|Trial size||40 participants|
|Trial identifier||NCT01064531, US-CR-130|
The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System, and to assess the long-term safety and effectiveness of the study device using Radiostereometric Analysis (RSA). This study will document any device-related surgical or post-operative complications and adverse radiographic observations.
Patients meeting the entrance criteria specified in this protocol will be randomized as they become available.
Subject will be randomized to either MIS or Synergy implant.
Subject will be randomized to either Synergy or MIS implant.
• RSA analysis of migration • Surgical and device related adverse events • Harris Hip Score • HOOS (Hip Osteoarthritis Outcome Score) questionnaire • Radiographic assessment
time frame: 3 months, 1 year, 2 years, 3 years, and 5 years. Additional radiographic analysis will be performed at 3 months, 1 year, 2 years, 3 years and 5 years. RSA scans will be performed at 6 weeks, 3 months, 6 months, 1 year, and 2 years.
time frame: Post operative through 5 years
Male or female participants up to 75 years old.
Inclusion Criteria: - Patient has hip disease that requires a total hip arthroplasty. - Patient is willing to consent to participation in the study. - Patient plans to be available for follow-up through study duration. - Patient is of stable health and is free of or treated and stabilized for any condition that would prose excessive operating risk. Exclusion Criteria: - Patient has insufficient femoral bone stock. - Patient has had major non-arthroscopic surgery to the study hip. - Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up. - Patient has a known sensitivity to materials in the device.
|Official title||A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip Systems by Radiostereometric Analysis|
|Principal investigator||Richard McCalden, MD|
|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 Radiostereometric Analysis (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.|
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