Mini Stem Radiostereometric Analysis Study (MISRSA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01064531|
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : October 18, 2016
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|Official Title:||A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip Systems by Radiostereometric Analysis|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
MIS Mini Stem implant
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. ]
- Adverse Events [ Time Frame: Post operative through 5 years ]All Perioperative and Postoperative device-related and surgical adverse events that occur regarding the MIS Stem subjects will be recorded during this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064531
|London Health Sciences Center- University Hospital|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Richard McCalden, MD||London Health Science Center|