Mini Stem Radiostereometric Analysis Study (MISRSA)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip Systems by Radiostereometric Analysis|
- • 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. ] [ Designated as safety issue: Yes ]
- Adverse Events [ Time Frame: Post operative through 5 years ] [ Designated as safety issue: Yes ]All Perioperative and Postoperative device-related and surgical adverse events that occur regarding the MIS Stem subjects will be recorded during this study.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
MIS Mini Stem implant
Subject will be randomized to either MIS or Synergy implant.
Subject will be randomized to either Synergy or MIS implant.
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.
|London Health Sciences Center- University Hospital|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Richard McCalden, MD||London Health Science Center|