Skip to main content
OpenTrials
Completed

NCT Number: NCT01064531

Mini Stem Radiostereometric Analysis Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

London Health Sciences Center- University Hospital

London, Ontario, N6A 5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MIS Femoral Neck Stem implant

Device

Primary outcomes

  1. Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)

    Time frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported

    Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.

  2. Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)

    Time frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported

    Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.

Secondary outcomes

  1. Preoperative Total Harris Hip Score (HHS)

    Time frame: Preoperative

    The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.

  2. 3 Months Postoperative Total Harris Hip Score (HHS)

    Time frame: 3 months postoperative

    The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.

  3. 1 Year Postoperative Total Harris Hip Score (HHS)

    Time frame: 1 year postoperative

    The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.

  4. 2 Years Postoperative Total Harris Hip Score (HHS)

    Time frame: 2 years postoperative

    The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.

  5. 3 Years Postoperative Total Harris Hip Score (HHS)

    Time frame: 3 years postoperative

    The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.

  6. 5 Years Postoperative Total Harris Hip Score (HHS)

    Time frame: 5 years postoperative

    The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.

  7. Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)

    Time frame: Preoperative

    The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.

    Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points

    Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.

  8. 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)

    Time frame: 3 months postoperative

    The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.

    Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points

    Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.

  9. 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)

    Time frame: 1 year postoperative

    The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.

    Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points

    Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.

  10. 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)

    Time frame: 2 years postoperative

    The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.

    Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points

    Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.

  11. 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)

    Time frame: 3 years postoperative

    The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.

    Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points

    Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.

  12. 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)

    Time frame: 5 years postoperative

    The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.

    Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points

    Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.

  13. Preoperative Radiographic Assessments

    Time frame: Preoperative

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

  14. 3 Months Postoperative Radiographic Assessments

    Time frame: 3 months postoperative

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

  15. 1 Year Postoperative Radiographic Assessments

    Time frame: 1 year postoperative

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

  16. 2 Years Postoperative Radiographic Assessments

    Time frame: 2 years postoperative

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

  17. 3 Years Postoperative Radiographic Assessments

    Time frame: 3 years postoperative

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

  18. 5 Years Postoperative Radiographic Assessments

    Time frame: 5 years postoperative

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip System by Radiostereometric Analysis

Acronym: MISRSA

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Feb 8, 2010
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.