Osteoarthritis, Hip
Conditions
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.
Interventions
DEVICEMIS Femoral Neck Stem implant
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Preoperative Radiographic Assessments | Preoperative | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. |
| 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 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. |
| 5 Years Postoperative Radiographic Assessments | 5 years postoperative | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. |
| 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. |
| 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. |
Countries
Canada
Participant flow
Recruitment details
Subjects were enrolled by 1 investigator in Canada. The study period was from 30 Jun 2009 to 22 Apr 2016.
Pre-assignment details
Preoperative evaluation was conducted following signing of the ICF but prior to randomization. A total of 41 subjects had surgery for either MIS Stem or Synergy implantation.
Participants by arm
| Arm | Count |
|---|---|
| MIS Femoral Neck Stem Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options. | 21 |
| Synergy Hip System Standard total hip arthroplasty (THA) using total hip system. | 20 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Revision due to dislocation | 0 | 1 |
| Overall Study | Revision due to femoral stem loosening | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | MIS Femoral Neck Stem | Total | Synergy Hip System |
|---|---|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 7.93 | 64.4 years STANDARD_DEVIATION 9.43 | 65.8 years STANDARD_DEVIATION 10.84 |
| BMI | 30.7 kg/m^2 STANDARD_DEVIATION 6.25 | 30.8 kg/m^2 STANDARD_DEVIATION 6.72 | 30.9 kg/m^2 STANDARD_DEVIATION 7.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 41 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 171.4 cm STANDARD_DEVIATION 9.12 | 170.0 cm STANDARD_DEVIATION 9.16 | 168.5 cm STANDARD_DEVIATION 9.19 |
| Primary Diagnosis: Charnley Classification Avascular necrosis: A unilateral hip joint disease | 1 Participants | 1 Participants | 0 Participants |
| Primary Diagnosis: Charnley Classification Osteoarthritis: A unilateral joint disease | 8 Participants | 15 Participants | 7 Participants |
| Primary Diagnosis: Charnley Classification Osteoarthritis: B1 bilateral hip joint disease | 9 Participants | 19 Participants | 10 Participants |
| Primary Diagnosis: Charnley Classification Osteoarthritis: C1 multi-joint arthroplasties | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Female | 8 Participants | 20 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 21 Participants | 8 Participants |
| Weight | 90.0 kg STANDARD_DEVIATION 18.22 | 89.0 kg STANDARD_DEVIATION 20.78 | 88.0 kg STANDARD_DEVIATION 23.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 1 / 20 |
| other Total, other adverse events | 15 / 21 | 15 / 20 |
| serious Total, serious adverse events | 2 / 21 | 4 / 20 |
Outcome results
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.
Time frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Population: Statistical comparisons were done using data from hips with all with RSA information at 2 years (20 MIS and 18 Synergy).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MIS Femoral Neck Stem | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement) | Mean rotation: Anterior-posterior | -0.475 degrees |
| MIS Femoral Neck Stem | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement) | Mean rotation: Internal-external | 0.958 degrees |
| MIS Femoral Neck Stem | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement) | Mean rotation: Varus-valgus tilt | -0.463 degrees |
| Synergy Hip System | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement) | Mean rotation: Anterior-posterior | -0.006 degrees |
| Synergy Hip System | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement) | Mean rotation: Internal-external | 1.414 degrees |
| Synergy Hip System | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement) | Mean rotation: Varus-valgus tilt | -0.091 degrees |
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.
Time frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Population: Statistical comparisons were done using data from hips with all with RSA information at 2 years (20 MIS and 18 Synergy).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MIS Femoral Neck Stem | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Mean translation: Medial-lateral | 0.204 mm |
| MIS Femoral Neck Stem | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Mean translation: Proximal-distal | -0.942 mm |
| MIS Femoral Neck Stem | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Mean translation: Anterior-posterior | -0.031 mm |
| MIS Femoral Neck Stem | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Mean translation: Total three-dimensional | 1.090 mm |
| Synergy Hip System | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Mean translation: Total three-dimensional | 0.728 mm |
| Synergy Hip System | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Mean translation: Medial-lateral | 0.224 mm |
| Synergy Hip System | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Mean translation: Anterior-posterior | -0.328 mm |
| Synergy Hip System | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Mean translation: Proximal-distal | -0.322 mm |
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.
Time frame: 1 year postoperative
Population: Data from hips with all with RSA information at 1 year (21 MIS and 15 Synergy).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Femoral Neck Stem | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 85.0 score on a scale | Standard Deviation 11.54 |
| MIS Femoral Neck Stem | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 77.1 score on a scale | Standard Deviation 19.09 |
| MIS Femoral Neck Stem | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 85.1 score on a scale | Standard Deviation 11.44 |
| MIS Femoral Neck Stem | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 76.2 score on a scale | Standard Deviation 18.39 |
| MIS Femoral Neck Stem | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 87.9 score on a scale | Standard Deviation 11.68 |
| Synergy Hip System | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 72.5 score on a scale | Standard Deviation 18.87 |
| Synergy Hip System | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 81.0 score on a scale | Standard Deviation 13.39 |
| Synergy Hip System | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 80.8 score on a scale | Standard Deviation 17.52 |
| Synergy Hip System | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 76.0 score on a scale | Standard Deviation 18.77 |
| Synergy Hip System | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 66.3 score on a scale | Standard Deviation 26.6 |
Secondary
1 Year Postoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 1 year postoperative
Population: Data from hips with all with RSA information at 1 year (20 MIS and 15 Synergy).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MIS Femoral Neck Stem | 1 Year Postoperative Radiographic Assessments | No Problems on Checklist | Yes | 15 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Radiographic Assessments | No Problems on Checklist | No | 5 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 20 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Radiographic Assessments | Stem Subsidence | No | 20 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 20 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 20 Participants |
| Synergy Hip System | 1 Year Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 15 Participants |
| Synergy Hip System | 1 Year Postoperative Radiographic Assessments | No Problems on Checklist | Yes | 11 Participants |
| Synergy Hip System | 1 Year Postoperative Radiographic Assessments | Stem Subsidence | No | 15 Participants |
| Synergy Hip System | 1 Year Postoperative Radiographic Assessments | No Problems on Checklist | No | 4 Participants |
| Synergy Hip System | 1 Year Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 15 Participants |
| Synergy Hip System | 1 Year Postoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| Synergy Hip System | 1 Year Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| Synergy Hip System | 1 Year Postoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 15 Participants |
| Synergy Hip System | 1 Year Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| Synergy Hip System | 1 Year Postoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
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.
Time frame: 1 year postoperative
Population: Data from hips with all with RSA information at 1 year (21 MIS and 15 Synergy).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIS Femoral Neck Stem | 1 Year Postoperative Total Harris Hip Score (HHS) | Good (80-89) | 6 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Total Harris Hip Score (HHS) | Poor (60-69) | 0 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Total Harris Hip Score (HHS) | Fair (70-79) | 0 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 0 Participants |
| MIS Femoral Neck Stem | 1 Year Postoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 15 Participants |
| Synergy Hip System | 1 Year Postoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 0 Participants |
| Synergy Hip System | 1 Year Postoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 10 Participants |
| Synergy Hip System | 1 Year Postoperative Total Harris Hip Score (HHS) | Good (80-89) | 2 Participants |
| Synergy Hip System | 1 Year Postoperative Total Harris Hip Score (HHS) | Fair (70-79) | 2 Participants |
| Synergy Hip System | 1 Year Postoperative Total Harris Hip Score (HHS) | Poor (60-69) | 1 Participants |
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.
Time frame: 2 years postoperative
Population: Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Femoral Neck Stem | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 84.2 score on a scale | Standard Deviation 15.8 |
| MIS Femoral Neck Stem | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 76.8 score on a scale | Standard Deviation 20.46 |
| MIS Femoral Neck Stem | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 82.4 score on a scale | Standard Deviation 17.61 |
| MIS Femoral Neck Stem | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 83.3 score on a scale | Standard Deviation 20.57 |
| MIS Femoral Neck Stem | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 87.9 score on a scale | Standard Deviation 11.57 |
| Synergy Hip System | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 75.4 score on a scale | Standard Deviation 16.84 |
| Synergy Hip System | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 82.2 score on a scale | Standard Deviation 12.11 |
| Synergy Hip System | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 81.7 score on a scale | Standard Deviation 21.09 |
| Synergy Hip System | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 72.1 score on a scale | Standard Deviation 22.41 |
| Synergy Hip System | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 74.6 score on a scale | Standard Deviation 23.88 |
Secondary
2 Years Postoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 2 years postoperative
Population: Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MIS Femoral Neck Stem | 2 Years Postoperative Radiographic Assessments | No Problems on Checklist | Yes | 11 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Radiographic Assessments | No Problems on Checklist | No | 10 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 21 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Radiographic Assessments | Stem Subsidence | Yes | 1 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Radiographic Assessments | Stem Subsidence | No | 20 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 21 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 21 Participants |
| Synergy Hip System | 2 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 16 Participants |
| Synergy Hip System | 2 Years Postoperative Radiographic Assessments | No Problems on Checklist | Yes | 12 Participants |
| Synergy Hip System | 2 Years Postoperative Radiographic Assessments | Stem Subsidence | No | 16 Participants |
| Synergy Hip System | 2 Years Postoperative Radiographic Assessments | No Problems on Checklist | No | 4 Participants |
| Synergy Hip System | 2 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 16 Participants |
| Synergy Hip System | 2 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| Synergy Hip System | 2 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| Synergy Hip System | 2 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 16 Participants |
| Synergy Hip System | 2 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| Synergy Hip System | 2 Years Postoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
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.
Time frame: 2 years postoperative
Population: Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIS Femoral Neck Stem | 2 Years Postoperative Total Harris Hip Score (HHS) | Good (80-89) | 4 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Total Harris Hip Score (HHS) | Poor (60-69) | 0 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Total Harris Hip Score (HHS) | Fair (70-79) | 2 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 1 Participants |
| MIS Femoral Neck Stem | 2 Years Postoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 14 Participants |
| Synergy Hip System | 2 Years Postoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 0 Participants |
| Synergy Hip System | 2 Years Postoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 7 Participants |
| Synergy Hip System | 2 Years Postoperative Total Harris Hip Score (HHS) | Good (80-89) | 6 Participants |
| Synergy Hip System | 2 Years Postoperative Total Harris Hip Score (HHS) | Fair (70-79) | 3 Participants |
| Synergy Hip System | 2 Years Postoperative Total Harris Hip Score (HHS) | Poor (60-69) | 0 Participants |
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.
Time frame: 3 months postoperative
Population: Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Femoral Neck Stem | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 85.1 score on a scale | Standard Deviation 12.4 |
| MIS Femoral Neck Stem | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 67.4 score on a scale | Standard Deviation 17.87 |
| MIS Femoral Neck Stem | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 81.8 score on a scale | Standard Deviation 9.75 |
| MIS Femoral Neck Stem | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 67.1 score on a scale | Standard Deviation 17.03 |
| MIS Femoral Neck Stem | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 81.9 score on a scale | Standard Deviation 11.63 |
| Synergy Hip System | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 66.0 score on a scale | Standard Deviation 20.02 |
| Synergy Hip System | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 77.2 score on a scale | Standard Deviation 17.41 |
| Synergy Hip System | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 76.9 score on a scale | Standard Deviation 18.59 |
| Synergy Hip System | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 76.0 score on a scale | Standard Deviation 18.51 |
| Synergy Hip System | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 61.3 score on a scale | Standard Deviation 20.82 |
Secondary
3 Months Postoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 3 months postoperative
Population: Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MIS Femoral Neck Stem | 3 Months Postoperative Radiographic Assessments | No Problems on Checklist | Yes | 19 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Radiographic Assessments | No Problems on Checklist | No | 0 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 19 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Radiographic Assessments | Stem Subsidence | No | 19 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 19 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 19 Participants |
| Synergy Hip System | 3 Months Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 16 Participants |
| Synergy Hip System | 3 Months Postoperative Radiographic Assessments | No Problems on Checklist | Yes | 16 Participants |
| Synergy Hip System | 3 Months Postoperative Radiographic Assessments | Stem Subsidence | No | 16 Participants |
| Synergy Hip System | 3 Months Postoperative Radiographic Assessments | No Problems on Checklist | No | 0 Participants |
| Synergy Hip System | 3 Months Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 16 Participants |
| Synergy Hip System | 3 Months Postoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| Synergy Hip System | 3 Months Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| Synergy Hip System | 3 Months Postoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 16 Participants |
| Synergy Hip System | 3 Months Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| Synergy Hip System | 3 Months Postoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
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.
Time frame: 3 months postoperative
Population: Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIS Femoral Neck Stem | 3 Months Postoperative Total Harris Hip Score (HHS) | Good (80-89) | 6 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Total Harris Hip Score (HHS) | Poor (60-69) | 0 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Total Harris Hip Score (HHS) | Fair (70-79) | 3 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 0 Participants |
| MIS Femoral Neck Stem | 3 Months Postoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 10 Participants |
| Synergy Hip System | 3 Months Postoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 0 Participants |
| Synergy Hip System | 3 Months Postoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 7 Participants |
| Synergy Hip System | 3 Months Postoperative Total Harris Hip Score (HHS) | Good (80-89) | 6 Participants |
| Synergy Hip System | 3 Months Postoperative Total Harris Hip Score (HHS) | Fair (70-79) | 1 Participants |
| Synergy Hip System | 3 Months Postoperative Total Harris Hip Score (HHS) | Poor (60-69) | 2 Participants |
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.
Time frame: 3 years postoperative
Population: Data from hips with all with RSA information at 3 years (15 MIS and 13 Synergy).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Femoral Neck Stem | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 84.0 score on a scale | Standard Deviation 18.51 |
| MIS Femoral Neck Stem | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 77.9 score on a scale | Standard Deviation 22.76 |
| MIS Femoral Neck Stem | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 86.0 score on a scale | Standard Deviation 19.38 |
| MIS Femoral Neck Stem | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 82.1 score on a scale | Standard Deviation 22.39 |
| MIS Femoral Neck Stem | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 88.0 score on a scale | Standard Deviation 17.91 |
| Synergy Hip System | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 79.8 score on a scale | Standard Deviation 25.91 |
| Synergy Hip System | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 81.9 score on a scale | Standard Deviation 17.26 |
| Synergy Hip System | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 85.8 score on a scale | Standard Deviation 17.45 |
| Synergy Hip System | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 73.0 score on a scale | Standard Deviation 23.15 |
| Synergy Hip System | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 75.0 score on a scale | Standard Deviation 19.93 |
Secondary
3 Years Postoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 3 years postoperative
Population: Data from all enrolled hips who received a study device (15 MIS and 13 Synergy).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MIS Femoral Neck Stem | 3 Years Postoperative Radiographic Assessments | No Problems on Checklist | Yes | 8 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Radiographic Assessments | No Problems on Checklist | No | 7 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 15 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Radiographic Assessments | Stem Subsidence | No | 15 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 15 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 15 Participants |
| Synergy Hip System | 3 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 13 Participants |
| Synergy Hip System | 3 Years Postoperative Radiographic Assessments | No Problems on Checklist | Yes | 7 Participants |
| Synergy Hip System | 3 Years Postoperative Radiographic Assessments | Stem Subsidence | No | 13 Participants |
| Synergy Hip System | 3 Years Postoperative Radiographic Assessments | No Problems on Checklist | No | 6 Participants |
| Synergy Hip System | 3 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 13 Participants |
| Synergy Hip System | 3 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| Synergy Hip System | 3 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| Synergy Hip System | 3 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 13 Participants |
| Synergy Hip System | 3 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| Synergy Hip System | 3 Years Postoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
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.
Time frame: 3 years postoperative
Population: Data from hips with all with RSA information at 3 years (15 MIS and 13 Synergy).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIS Femoral Neck Stem | 3 Years Postoperative Total Harris Hip Score (HHS) | Fair (70-79) | 0 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Total Harris Hip Score (HHS) | Poor (60-69) | 0 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Total Harris Hip Score (HHS) | Good (80-89) | 2 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 1 Participants |
| MIS Femoral Neck Stem | 3 Years Postoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 12 Participants |
| Synergy Hip System | 3 Years Postoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 0 Participants |
| Synergy Hip System | 3 Years Postoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 9 Participants |
| Synergy Hip System | 3 Years Postoperative Total Harris Hip Score (HHS) | Good (80-89) | 1 Participants |
| Synergy Hip System | 3 Years Postoperative Total Harris Hip Score (HHS) | Poor (60-69) | 1 Participants |
| Synergy Hip System | 3 Years Postoperative Total Harris Hip Score (HHS) | Fair (70-79) | 2 Participants |
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.
Time frame: 5 years postoperative
Population: Data from hips with all with RSA information at 3 years (17 MIS and 12 Synergy).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Femoral Neck Stem | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 81.2 score on a scale | Standard Deviation 18.95 |
| MIS Femoral Neck Stem | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 68.4 score on a scale | Standard Deviation 30.09 |
| MIS Femoral Neck Stem | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 76.7 score on a scale | Standard Deviation 21.51 |
| MIS Femoral Neck Stem | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 71.0 score on a scale | Standard Deviation 28.38 |
| MIS Femoral Neck Stem | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 85.3 score on a scale | Standard Deviation 15.96 |
| Synergy Hip System | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 75.0 score on a scale | Standard Deviation 29.07 |
| Synergy Hip System | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 84.4 score on a scale | Standard Deviation 20.12 |
| Synergy Hip System | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 78.1 score on a scale | Standard Deviation 25.45 |
| Synergy Hip System | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 71.0 score on a scale | Standard Deviation 25.33 |
| Synergy Hip System | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 50.0 score on a scale | Standard Deviation 45.54 |
Secondary
5 Years Postoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 5 years postoperative
Population: Data from all enrolled hips who received a study device (17 MIS and 12 Synergy).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MIS Femoral Neck Stem | 5 Years Postoperative Radiographic Assessments | No Problems on Checklist | Yes | 13 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Radiographic Assessments | No Problems on Checklist | No | 4 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 17 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Radiographic Assessments | Stem Subsidence | No | 17 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 17 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 17 Participants |
| Synergy Hip System | 5 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 12 Participants |
| Synergy Hip System | 5 Years Postoperative Radiographic Assessments | No Problems on Checklist | Yes | 11 Participants |
| Synergy Hip System | 5 Years Postoperative Radiographic Assessments | Stem Subsidence | No | 12 Participants |
| Synergy Hip System | 5 Years Postoperative Radiographic Assessments | No Problems on Checklist | No | 1 Participants |
| Synergy Hip System | 5 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 12 Participants |
| Synergy Hip System | 5 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| Synergy Hip System | 5 Years Postoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| Synergy Hip System | 5 Years Postoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 12 Participants |
| Synergy Hip System | 5 Years Postoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| Synergy Hip System | 5 Years Postoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
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.
Time frame: 5 years postoperative
Population: Data from hips with all with RSA information at 5 years (17 MIS and 12 Synergy).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIS Femoral Neck Stem | 5 Years Postoperative Total Harris Hip Score (HHS) | Poor (60-69) | 0 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 9 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Total Harris Hip Score (HHS) | Good (80-89) | 4 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Total Harris Hip Score (HHS) | Fair (70-79) | 3 Participants |
| MIS Femoral Neck Stem | 5 Years Postoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 1 Participants |
| Synergy Hip System | 5 Years Postoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 0 Participants |
| Synergy Hip System | 5 Years Postoperative Total Harris Hip Score (HHS) | Fair (70-79) | 0 Participants |
| Synergy Hip System | 5 Years Postoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 8 Participants |
| Synergy Hip System | 5 Years Postoperative Total Harris Hip Score (HHS) | Poor (60-69) | 1 Participants |
| Synergy Hip System | 5 Years Postoperative Total Harris Hip Score (HHS) | Good (80-89) | 3 Participants |
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.
Time frame: Preoperative
Population: Data from hips with all with RSA information at pre-operative visit (21 MIS and 20 Synergy).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Femoral Neck Stem | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 37.1 score on a scale | Standard Deviation 17.73 |
| MIS Femoral Neck Stem | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 27.1 score on a scale | Standard Deviation 19.7 |
| MIS Femoral Neck Stem | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 41.0 score on a scale | Standard Deviation 19.52 |
| MIS Femoral Neck Stem | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 23.2 score on a scale | Standard Deviation 14.27 |
| MIS Femoral Neck Stem | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 47.4 score on a scale | Standard Deviation 17.58 |
| Synergy Hip System | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Quality of Life (0-100) | 23.4 score on a scale | Standard Deviation 13.43 |
| Synergy Hip System | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Symptoms and Stiffness (0-100) | 40.5 score on a scale | Standard Deviation 16.05 |
| Synergy Hip System | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Pain (0-100) | 33.5 score on a scale | Standard Deviation 17.44 |
| Synergy Hip System | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Daily Living (0-100) | 33.4 score on a scale | Standard Deviation 16.97 |
| Synergy Hip System | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | Sports/ Recreational Activities (0-100) | 22.8 score on a scale | Standard Deviation 15.08 |
Secondary
Preoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: Preoperative
Population: Data from all enrolled hips who received a study device (21 MIS and 20 Synergy).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MIS Femoral Neck Stem | Preoperative Radiographic Assessments | No Problems on Checklist | Yes | 21 Participants |
| MIS Femoral Neck Stem | Preoperative Radiographic Assessments | No Problems on Checklist | No | 0 Participants |
| MIS Femoral Neck Stem | Preoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | Preoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 21 Participants |
| MIS Femoral Neck Stem | Preoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
| MIS Femoral Neck Stem | Preoperative Radiographic Assessments | Stem Subsidence | No | 21 Participants |
| MIS Femoral Neck Stem | Preoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | Preoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 21 Participants |
| MIS Femoral Neck Stem | Preoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| MIS Femoral Neck Stem | Preoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 21 Participants |
| Synergy Hip System | Preoperative Radiographic Assessments | Evidence of Acetabular Component Failure | No | 20 Participants |
| Synergy Hip System | Preoperative Radiographic Assessments | No Problems on Checklist | Yes | 20 Participants |
| Synergy Hip System | Preoperative Radiographic Assessments | Stem Subsidence | No | 20 Participants |
| Synergy Hip System | Preoperative Radiographic Assessments | No Problems on Checklist | No | 0 Participants |
| Synergy Hip System | Preoperative Radiographic Assessments | Evidence of Femoral Component Failure | No | 20 Participants |
| Synergy Hip System | Preoperative Radiographic Assessments | Acetabular Cup Subsidence | Yes | 0 Participants |
| Synergy Hip System | Preoperative Radiographic Assessments | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| Synergy Hip System | Preoperative Radiographic Assessments | Acetabular Cup Subsidence | No | 20 Participants |
| Synergy Hip System | Preoperative Radiographic Assessments | Evidence of Femoral Component Failure | Yes | 0 Participants |
| Synergy Hip System | Preoperative Radiographic Assessments | Stem Subsidence | Yes | 0 Participants |
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.
Time frame: Preoperative
Population: Data from hips with all with RSA information at pre-operative visit (21 MIS and 20 Synergy).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIS Femoral Neck Stem | Preoperative Total Harris Hip Score (HHS) | Good (80-89) | 1 Participants |
| MIS Femoral Neck Stem | Preoperative Total Harris Hip Score (HHS) | Poor (60-69) | 3 Participants |
| MIS Femoral Neck Stem | Preoperative Total Harris Hip Score (HHS) | Fair (70-79) | 1 Participants |
| MIS Femoral Neck Stem | Preoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 16 Participants |
| MIS Femoral Neck Stem | Preoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 0 Participants |
| Synergy Hip System | Preoperative Total Harris Hip Score (HHS) | Very Poor (<60) | 18 Participants |
| Synergy Hip System | Preoperative Total Harris Hip Score (HHS) | Excellent (90-100) | 0 Participants |
| Synergy Hip System | Preoperative Total Harris Hip Score (HHS) | Good (80-89) | 0 Participants |
| Synergy Hip System | Preoperative Total Harris Hip Score (HHS) | Fair (70-79) | 1 Participants |
| Synergy Hip System | Preoperative Total Harris Hip Score (HHS) | Poor (60-69) | 1 Participants |