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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: December 20, 2013
Last verified: December 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 20, 2013
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 November 24, 2014