Clinical trial NCT01064531: Mini Stem Radiostereometric Analysis Study
Official title: A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip System by Radiostereometric Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 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.

Brief summary: The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. This study will document any device-related surgical or post-operative complications and adverse radiographic observations.

Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.

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 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 criteria: Inclusion Criteria:

* Subject has hip disease that requires a total hip arthroplasty.
* Subject is willing to consent to participation in the study.
* Subject plans to be available for follow-up through study duration.
* Subject is of stable health and is free of or treated and stabilized for any condition that would prose excessive operating risk.

Exclusion Criteria:

* Subject has insufficient femoral bone stock.
* Subject has had major non-arthroscopic surgery to the study hip.
* Subject has physical, emotional or neurological conditions that would compromise the subjects compliance with postoperative rehabilitation and follow-up.
* Subject has a known sensitivity to materials in the device.

Primary outcomes:
measure: Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)
timeFrame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
measure: Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)
timeFrame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Secondary outcomes:
measure: Preoperative Total Harris Hip Score (HHS)
timeFrame: Preoperative
measure: 3 Months Postoperative Total Harris Hip Score (HHS)
timeFrame: 3 months postoperative
measure: 1 Year Postoperative Total Harris Hip Score (HHS)
timeFrame: 1 year postoperative
measure: 2 Years Postoperative Total Harris Hip Score (HHS)
timeFrame: 2 years postoperative
measure: 3 Years Postoperative Total Harris Hip Score (HHS)
timeFrame: 3 years postoperative
measure: 5 Years Postoperative Total Harris Hip Score (HHS)
timeFrame: 5 years postoperative
measure: Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
timeFrame: Preoperative
measure: 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
timeFrame: 3 months postoperative
measure: 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
timeFrame: 1 year postoperative
measure: 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
timeFrame: 2 years postoperative
measure: 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
timeFrame: 3 years postoperative
measure: 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
timeFrame: 5 years postoperative
measure: Preoperative Radiographic Assessments
timeFrame: Preoperative
measure: 3 Months Postoperative Radiographic Assessments
timeFrame: 3 months postoperative
measure: 1 Year Postoperative Radiographic Assessments
timeFrame: 1 year postoperative
measure: 2 Years Postoperative Radiographic Assessments
timeFrame: 2 years postoperative
measure: 3 Years Postoperative Radiographic Assessments
timeFrame: 3 years postoperative
measure: 5 Years Postoperative Radiographic Assessments
timeFrame: 5 years postoperative
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Center- University Hospital
state: Ontario
Study officials:
affiliation: London Health Science Center
name: Richard McCalden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vice President, Global Clinical Strategy and Global Clinical Operations
name: Beate Hanson, MD, PhD
role: STUDY_CHAIR
References: