Mini Stem Radiostereometric Analysis Study

Completed

Conditions: Osteoarthritis, Hip

Interventions: Device: MIS Femoral Neck Stem implant

Registration Number: NCT01064531

Lead Sponsor: Smith & Nephew, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Synergy Hip System	MIS Femoral Neck Stem implant	Subject will be randomized to either Synergy or MIS implant.
MIS Femoral Neck Stem	MIS Femoral Neck Stem implant	Subject will be randomized to either MIS or Synergy implant.

Primary Outcome Measures

Name	Time	Method
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)	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.
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)	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 Outcome Measures

Name	Time	Method
Preoperative Total Harris Hip Score (HHS)	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.
3 Months Postoperative Total Harris Hip Score (HHS)	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.
1 Year Postoperative Total Harris Hip Score (HHS)	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.
2 Years Postoperative Total Harris Hip Score (HHS)	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.
Preoperative Radiographic Assessments	Preoperative	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
3 Years Postoperative Total Harris Hip Score (HHS)	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.
1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.
5 Years Postoperative Radiographic Assessments	5 years postoperative	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
5 Years Postoperative Total Harris Hip Score (HHS)	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.
Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.
3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.
5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.
3 Months Postoperative Radiographic Assessments	3 months postoperative	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
1 Year Postoperative Radiographic Assessments	1 year postoperative	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.
3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)	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.
2 Years Postoperative Radiographic Assessments	2 years postoperative	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
3 Years Postoperative Radiographic Assessments	3 years postoperative	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.