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Mini Stem Radiostereometric Analysis Study (MISRSA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01064531
First received: February 5, 2010
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Osteoarthritis, Hip

Study Type: Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 4
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)
Groups/Cohorts
MIS Mini Stem implant
Subject will be randomized to either MIS or Synergy implant.
Synergy implant
Subject will be randomized to either Synergy or MIS implant.

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 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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064531

Locations
Canada, Ontario
London Health Sciences Center- University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Principal Investigator: Richard McCalden, MD London Health Science Center
  More Information

No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01064531     History of Changes
Other Study ID Numbers: US-CR-130
Study First Received: February 5, 2010
Last Updated: September 17, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013