Mini Stem Radiostereometric Analysis Study

Osteoarthritis, Hip Clinical Trial

— MISRSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064531
• Other study ID #: US-CR-130
• Status: Completed
• Start date: June 30, 2009
• Est. completion date: April 22, 2016

Study information

• Verified date: April 2020
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 22, 2016
• Est. primary completion date: April 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Device:
• MIS Femoral Neck Stem implant

Locations

Country	Name	City	State
Canada	London Health Sciences Center- University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)	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.	Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Primary	Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)	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.	Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Secondary	Preoperative Total Harris Hip Score (HHS)	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.	Preoperative
Secondary	3 Months Postoperative Total Harris Hip Score (HHS)	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 months postoperative
Secondary	1 Year Postoperative Total Harris Hip Score (HHS)	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.	1 year postoperative
Secondary	2 Years Postoperative Total Harris Hip Score (HHS)	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 years postoperative
Secondary	3 Years Postoperative Total Harris Hip Score (HHS)	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 years postoperative
Secondary	5 Years Postoperative Total Harris Hip Score (HHS)	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 years postoperative
Secondary	Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.	Preoperative
Secondary	3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.	3 months postoperative
Secondary	1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.	1 year postoperative
Secondary	2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.	2 years postoperative
Secondary	3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.	3 years postoperative
Secondary	5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.	5 years postoperative
Secondary	Preoperative Radiographic Assessments	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.	Preoperative
Secondary	3 Months Postoperative Radiographic Assessments	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.	3 months postoperative
Secondary	1 Year Postoperative Radiographic Assessments	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.	1 year postoperative
Secondary	2 Years Postoperative Radiographic Assessments	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.	2 years postoperative
Secondary	3 Years Postoperative Radiographic Assessments	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.	3 years postoperative
Secondary	5 Years Postoperative Radiographic Assessments	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.	5 years postoperative