Osteoarthritis, Hip
Conditions
Brief summary
The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.
Detailed description
The purpose of the current investigation is to assess the bone ingrowth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a primary total hip replacement.
Interventions
None listed
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient has hip disease that requires a total hip arthroplasty. * Patient is willing to consent to participate in the study. * Patient plans to be available for the study duration. * Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
Exclusion criteria
* Patient known to have insufficient bone stock. * Patient has had major non-arthroscopic surgery to the study hip. * Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up. * Patient has a known sensitivity to materials in the device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DEXA Analysis of BMD at Preoperative Visit | Preoperative | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. |
| DEXA Analysis of BMD at 3 Months | 3 Months | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. |
| DEXA Analysis of BMD at 6 Months | 6 Months | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. |
| DEXA Analysis of BMD at 1 Year | 1 Year | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. |
| DEXA Analysis of BMD at 2 Years | 2 Year | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) at 5 Year Visit | 5 Year | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit | Preoperative | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit | 3 Months | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit | 6 Months | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit | 1 Year | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit | 2 Years | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit | 5 Years | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. |
| Radiographic Assessment at Preoperative Visit (Yes/No Components) | Discharge | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip |
| Radiographic Assessment at 3 Month Visit (Yes/No Components) | 3 Months | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip |
| Baseline Harris Hip Score (HHS) at Preoperative Visit | Preoperative | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. |
| Radiographic Assessment at 5 Year Visit (Yes/No Components) | 5 Year | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip |
| Radiographic Assessment at Discharge Visit | Discharge | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. |
| Radiographic Assessment at 3 Month Visit | 3 Months | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. |
| Radiographic Assessment at 1 Year Visit | 1 Year | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. |
| Radiographic Assessment at 5 Year Visit | 5 Year | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. |
| Radiographic Assessment at Discharge Visit (Neutral/Valgus Component) | Discharge | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. |
| Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component) | 3 Months | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. |
| Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component) | 1 Year | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. |
| Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component) | 5 Years | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. |
| Radiographic Assessment at 1 Year Visit (Yes/No Components) | 1 Year | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip |
| Harris Hip Score (HHS) at 3 Month Visit | 3 Month | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. |
| Harris Hip Score (HHS) at 6 Month Visit | 6 Months | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. |
| Harris Hip Score (HHS) at 1 Year Visit | 1 Year | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. |
| Harris Hip Score (HHS) at 2 Year Visit | 2 Years | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. |
Countries
Australia
Participant flow
Recruitment details
This study was conducted by 1 investigator in 1 country from 14 Sep 2009 to 18 Apr 2016.
Pre-assignment details
A total of 22 subjects were screened, with 20 subjects enrolled and had surgery/MIS implanted.
Participants by arm
| Arm | Count |
|---|---|
| MIS Stem Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. All subjects had implantation of the MIS femoral stem/modular neck during THA. DEXA was used to assess the bone ingrowth and detect significant alterations in skeletal structure that may not be visible during routine clinical assessment. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Device revised/removed | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | MIS Stem |
|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 9.63 |
| Body Mass Index (BMI) | 31.3 kg/m^2 STANDARD_DEVIATION 3.69 |
| Height | 170.2 cm STANDARD_DEVIATION 7.39 |
| Primary Diagnosis Charnley Classification Avascular necrosis: B1 Bilateral Hip Joint Disease | 1 Participants |
| Primary Diagnosis Charnley Classification Osteoarthritis: A Unilateral Hip Joint Disease | 14 Participants |
| Primary Diagnosis Charnley Classification Osteoarthritis: B1 Bilateral Hip Joint Disease | 4 Participants |
| Primary Diagnosis Charnley Classification Rheumatoid arthritis:C1 Multi-joint arthroplasties | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 19 Participants |
| Race/Ethnicity, Customized European | 1 Participants |
| Region of Enrollment Australia | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
| Weight | 90.8 kg STANDARD_DEVIATION 12.39 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 20 |
| other Total, other adverse events | 14 / 20 |
| serious Total, serious adverse events | 13 / 20 |
Outcome results
Primary
DEXA Analysis of BMD at 1 Year
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Time frame: 1 Year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | DEXA Analysis of BMD at 1 Year | Femoral Region 1 | 0.8 g/cm^2 | Standard Deviation 0.2 |
| MIS Stem | DEXA Analysis of BMD at 1 Year | Femoral Region 2 | 1.3 g/cm^2 | Standard Deviation 0.29 |
| MIS Stem | DEXA Analysis of BMD at 1 Year | Femoral Region 3 | 2.1 g/cm^2 | Standard Deviation 0.41 |
| MIS Stem | DEXA Analysis of BMD at 1 Year | Femoral Region 4 | 1.9 g/cm^2 | Standard Deviation 0.3 |
| MIS Stem | DEXA Analysis of BMD at 1 Year | Femoral Region 5 | 1.9 g/cm^2 | Standard Deviation 0.31 |
| MIS Stem | DEXA Analysis of BMD at 1 Year | Femoral Region 6 | 1.6 g/cm^2 | Standard Deviation 0.37 |
| MIS Stem | DEXA Analysis of BMD at 1 Year | Femoral Region 7 | 1.3 g/cm^2 | Standard Deviation 0.3 |
Primary
DEXA Analysis of BMD at 2 Years
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Time frame: 2 Year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | DEXA Analysis of BMD at 2 Years | Femoral Region 1 | 0.8 g/cm^2 | Standard Deviation 0.21 |
| MIS Stem | DEXA Analysis of BMD at 2 Years | Femoral Region 2 | 1.3 g/cm^2 | Standard Deviation 0.33 |
| MIS Stem | DEXA Analysis of BMD at 2 Years | Femoral Region 3 | 2.2 g/cm^2 | Standard Deviation 0.31 |
| MIS Stem | DEXA Analysis of BMD at 2 Years | Femoral Region 4 | 1.9 g/cm^2 | Standard Deviation 0.29 |
| MIS Stem | DEXA Analysis of BMD at 2 Years | Femoral Region 5 | 2.0 g/cm^2 | Standard Deviation 0.32 |
| MIS Stem | DEXA Analysis of BMD at 2 Years | Femoral Region 6 | 1.6 g/cm^2 | Standard Deviation 0.39 |
| MIS Stem | DEXA Analysis of BMD at 2 Years | Femoral Region 7 | 1.3 g/cm^2 | Standard Deviation 0.25 |
Primary
DEXA Analysis of BMD at 3 Months
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Time frame: 3 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | DEXA Analysis of BMD at 3 Months | Femoral Region 1 | 0.8 g/cm^2 | Standard Deviation 0.18 |
| MIS Stem | DEXA Analysis of BMD at 3 Months | Femoral Region 2 | 1.3 g/cm^2 | Standard Deviation 0.26 |
| MIS Stem | DEXA Analysis of BMD at 3 Months | Femoral Region 3 | 2.1 g/cm^2 | Standard Deviation 0.39 |
| MIS Stem | DEXA Analysis of BMD at 3 Months | Femoral Region 4 | 1.9 g/cm^2 | Standard Deviation 0.27 |
| MIS Stem | DEXA Analysis of BMD at 3 Months | Femoral Region 5 | 1.9 g/cm^2 | Standard Deviation 0.27 |
| MIS Stem | DEXA Analysis of BMD at 3 Months | Femoral Region 6 | 1.5 g/cm^2 | Standard Deviation 0.32 |
| MIS Stem | DEXA Analysis of BMD at 3 Months | Femoral Region 7 | 1.3 g/cm^2 | Standard Deviation 0.27 |
Primary
DEXA Analysis of BMD at 6 Months
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Time frame: 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | DEXA Analysis of BMD at 6 Months | Femoral Region 1 | 0.8 g/cm^2 | Standard Deviation 0.19 |
| MIS Stem | DEXA Analysis of BMD at 6 Months | Femoral Region 2 | 1.3 g/cm^2 | Standard Deviation 0.31 |
| MIS Stem | DEXA Analysis of BMD at 6 Months | Femoral Region 3 | 2.1 g/cm^2 | Standard Deviation 0.38 |
| MIS Stem | DEXA Analysis of BMD at 6 Months | Femoral Region 4 | 1.9 g/cm^2 | Standard Deviation 0.3 |
| MIS Stem | DEXA Analysis of BMD at 6 Months | Femoral Region 5 | 2.0 g/cm^2 | Standard Deviation 0.28 |
| MIS Stem | DEXA Analysis of BMD at 6 Months | Femoral Region 6 | 1.6 g/cm^2 | Standard Deviation 0.3 |
| MIS Stem | DEXA Analysis of BMD at 6 Months | Femoral Region 7 | 1.2 g/cm^2 | Standard Deviation 0.35 |
Primary
DEXA Analysis of BMD at Preoperative Visit
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Time frame: Preoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | DEXA Analysis of BMD at Preoperative Visit | Femoral Region 1 | 0.8 g/cm^2 | Standard Deviation 0.22 |
| MIS Stem | DEXA Analysis of BMD at Preoperative Visit | Femoral Region 2 | 1.0 g/cm^2 | Standard Deviation 0.25 |
| MIS Stem | DEXA Analysis of BMD at Preoperative Visit | Femoral Region 3 | 1.6 g/cm^2 | Standard Deviation 0.31 |
| MIS Stem | DEXA Analysis of BMD at Preoperative Visit | Femoral Region 4 | 2.0 g/cm^2 | Standard Deviation 0.32 |
| MIS Stem | DEXA Analysis of BMD at Preoperative Visit | Femoral Region 5 | 1.8 g/cm^2 | Standard Deviation 0.33 |
| MIS Stem | DEXA Analysis of BMD at Preoperative Visit | Femoral Region 6 | 1.3 g/cm^2 | Standard Deviation 0.29 |
| MIS Stem | DEXA Analysis of BMD at Preoperative Visit | Femoral Region 7 | 1.4 g/cm^2 | Standard Deviation 0.31 |
Secondary
Baseline Harris Hip Score (HHS) at Preoperative Visit
The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time frame: Preoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Baseline Harris Hip Score (HHS) at Preoperative Visit | Pain | 17.0 score on a scale | Standard Deviation 7.33 |
| MIS Stem | Baseline Harris Hip Score (HHS) at Preoperative Visit | Function | 26.0 score on a scale | Standard Deviation 7.58 |
| MIS Stem | Baseline Harris Hip Score (HHS) at Preoperative Visit | Absence of Deformity | 3.8 score on a scale | Standard Deviation 0.89 |
| MIS Stem | Baseline Harris Hip Score (HHS) at Preoperative Visit | Range of Motion | 2.7 score on a scale | Standard Deviation 0.86 |
| MIS Stem | Baseline Harris Hip Score (HHS) at Preoperative Visit | Total | 49.5 score on a scale | Standard Deviation 13.53 |
Secondary
Harris Hip Score (HHS) at 1 Year Visit
The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time frame: 1 Year
Population: Two subjects were missing results from the study site for the HHS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Harris Hip Score (HHS) at 1 Year Visit | Pain | 38.0 score on a scale | Standard Deviation 9.27 |
| MIS Stem | Harris Hip Score (HHS) at 1 Year Visit | Function | 41.5 score on a scale | Standard Deviation 7.14 |
| MIS Stem | Harris Hip Score (HHS) at 1 Year Visit | Absence of Deformity | 4.0 score on a scale | Standard Deviation 0 |
| MIS Stem | Harris Hip Score (HHS) at 1 Year Visit | Range of Motion | 4.5 score on a scale | Standard Deviation 0.62 |
| MIS Stem | Harris Hip Score (HHS) at 1 Year Visit | Total | 87.3 score on a scale | Standard Deviation 16.13 |
Secondary
Harris Hip Score (HHS) at 2 Year Visit
The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time frame: 2 Years
Population: Number of participants returning for this time point visit assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Harris Hip Score (HHS) at 2 Year Visit | Pain | 40.7 score on a scale | Standard Deviation 7.11 |
| MIS Stem | Harris Hip Score (HHS) at 2 Year Visit | Function | 41.9 score on a scale | Standard Deviation 5.79 |
| MIS Stem | Harris Hip Score (HHS) at 2 Year Visit | Absence of Deformity | 4.0 score on a scale | Standard Deviation 0 |
| MIS Stem | Harris Hip Score (HHS) at 2 Year Visit | Range of Motion | 4.0 score on a scale | Standard Deviation 0.45 |
| MIS Stem | Harris Hip Score (HHS) at 2 Year Visit | Total | 90.6 score on a scale | Standard Deviation 11.57 |
Secondary
Harris Hip Score (HHS) at 3 Month Visit
The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time frame: 3 Month
Population: Overall number of participants analyzed was 20 particpants; however, for the Function and Total Overall portion of the questionnaire only 18 participants responded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Harris Hip Score (HHS) at 3 Month Visit | Pain | 37.5 score on a scale | Standard Deviation 9.56 |
| MIS Stem | Harris Hip Score (HHS) at 3 Month Visit | Function | 35.1 score on a scale | Standard Deviation 5.6 |
| MIS Stem | Harris Hip Score (HHS) at 3 Month Visit | Absence of Deformity | 4.0 score on a scale | Standard Deviation 0 |
| MIS Stem | Harris Hip Score (HHS) at 3 Month Visit | Range of Motion | 4.1 score on a scale | Standard Deviation 0.69 |
| MIS Stem | Harris Hip Score (HHS) at 3 Month Visit | Total | 82.6 score on a scale | Standard Deviation 10.15 |
Secondary
Harris Hip Score (HHS) at 5 Year Visit
The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time frame: 5 Year
Population: Number of participants returning for this time point visit assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Harris Hip Score (HHS) at 5 Year Visit | Pain | 43.6 score on a scale | Standard Deviation 1.33 |
| MIS Stem | Harris Hip Score (HHS) at 5 Year Visit | Function | 45.8 score on a scale | Standard Deviation 1.48 |
| MIS Stem | Harris Hip Score (HHS) at 5 Year Visit | Absence of Deformity | 4.0 score on a scale | Standard Deviation 0 |
| MIS Stem | Harris Hip Score (HHS) at 5 Year Visit | Range of Motion | 4.3 score on a scale | Standard Deviation 0.5 |
| MIS Stem | Harris Hip Score (HHS) at 5 Year Visit | Total | 97.7 score on a scale | Standard Deviation 2.45 |
Secondary
Harris Hip Score (HHS) at 6 Month Visit
The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time frame: 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Harris Hip Score (HHS) at 6 Month Visit | Pain | 40.8 score on a scale | Standard Deviation 5.29 |
| MIS Stem | Harris Hip Score (HHS) at 6 Month Visit | Function | 41.2 score on a scale | Standard Deviation 5.67 |
| MIS Stem | Harris Hip Score (HHS) at 6 Month Visit | Absence of Deformity | 4.0 score on a scale | Standard Deviation 0 |
| MIS Stem | Harris Hip Score (HHS) at 6 Month Visit | Range of Motion | 4.2 score on a scale | Standard Deviation 0.37 |
| MIS Stem | Harris Hip Score (HHS) at 6 Month Visit | Total | 90.1 score on a scale | Standard Deviation 7.22 |
Secondary
Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time frame: 1 Year
Population: Number of participants returning for this time point visit assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit | Symptoms and Stiffness | 90.0 score on a scale | Standard Deviation 14.14 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit | Pain | 89.2 score on a scale | Standard Deviation 14.54 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit | Daily Living | 87.8 score on a scale | Standard Deviation 15.62 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit | Sports/Recreational Activities | 78.3 score on a scale | Standard Deviation 28.8 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit | Quality of Life | 82.4 score on a scale | Standard Deviation 25.13 |
Secondary
Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time frame: 2 Years
Population: Number of participants returning for this time point visit assessment. Information was not provided from the study site for 1 subject in the HOOS Sports/Recreational Activities (0-100) and Quality of Life (0-100) categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit | Daily Living | 89.9 score on a scale | Standard Deviation 12.54 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit | Symptoms and Stiffness | 90.7 score on a scale | Standard Deviation 8.05 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit | Pain | 92.5 score on a scale | Standard Deviation 10.28 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit | Sports/Recreational Activities | 81.6 score on a scale | Standard Deviation 20.6 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit | Quality of Life | 81.7 score on a scale | Standard Deviation 22.74 |
Secondary
Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time frame: 3 Months
Population: Information was not provided from the study site for two subjects in the HOOS Sports/Recreational Activities (0-100) category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit | Symptoms and Stiffness | 83.0 score on a scale | Standard Deviation 13.42 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit | Pain | 88.8 score on a scale | Standard Deviation 13.39 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit | Daily Living | 84.8 score on a scale | Standard Deviation 12.29 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit | Sports/Recreational Activities | 76.0 score on a scale | Standard Deviation 22.7 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit | Quality of Life | 73.1 score on a scale | Standard Deviation 22.86 |
Secondary
Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time frame: 5 Years
Population: Information was not provided from the study site for 1 subject in the HOOS Pain (0-100), Daily Living (0-100), Sports/Recreational Activities (0-100), and Quality of Life (0-100) categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit | Symptoms and Stiffness | 96.5 score on a scale | Standard Deviation 6.69 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit | Pain | 98.3 score on a scale | Standard Deviation 4.15 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit | Daily Living | 97.2 score on a scale | Standard Deviation 5.27 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit | Sports/Recreational Activities | 85.6 score on a scale | Standard Deviation 21.91 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit | Quality of Life | 95.8 score on a scale | Standard Deviation 6.99 |
Secondary
Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time frame: 6 Months
Population: Information was not provided from the study site for two subjects in the HOOS Sports/Recreational Activities (0-100) category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit | Symptoms and Stiffness | 93.0 score on a scale | Standard Deviation 10.31 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit | Pain | 94.2 score on a scale | Standard Deviation 7.82 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit | Daily Living | 93.0 score on a scale | Standard Deviation 6.8 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit | Sports/Recreational Activities | 80.4 score on a scale | Standard Deviation 17.37 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit | Quality of Life | 83.8 score on a scale | Standard Deviation 14.68 |
Secondary
Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time frame: Preoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit | Symptoms and Stiffness | 52.8 score on a scale | Standard Deviation 18.53 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit | Pain | 49.1 score on a scale | Standard Deviation 17.5 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit | Daily Living | 44.7 score on a scale | Standard Deviation 17.19 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit | Sports/Recreational Activities | 22.1 score on a scale | Standard Deviation 19.98 |
| MIS Stem | Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit | Quality of Life | 24.7 score on a scale | Standard Deviation 14.97 |
Secondary
Radiographic Assessment at 1 Year Visit
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 1 Year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Radiographic Assessment at 1 Year Visit | Femoral Valgus Position Degree | 0 degree | Standard Deviation 0 |
| MIS Stem | Radiographic Assessment at 1 Year Visit | Acetabular Component Position Degree | 41.3 degree | Standard Deviation 2.9 |
Secondary
Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 1 Year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIS Stem | Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component) | Neutral | 20 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component) | Valgus | 0 Participants |
Secondary
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip
Time frame: 1 Year
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Evidence of Femoral Component Failure | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | No Problems on Checklist | Yes | 19 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | No Problems on Checklist | No | 1 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Acetabular Component Position Degree | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Acetabular Component Position Degree | No | 20 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Stem Subsidence | Yes | 1 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Stem Subsidence | No | 19 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Evidence of Acetabular Component Failure | No | 20 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Evidence of Femoral Component Failure | No | 20 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Brooker Classification | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Brooker Classification | No | 20 Participants |
Secondary
Radiographic Assessment at 3 Month Visit
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 3 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Radiographic Assessment at 3 Month Visit | Femoral Valgus Position Degree | 0 degree | Standard Deviation 0 |
| MIS Stem | Radiographic Assessment at 3 Month Visit | Acetabular Component Position Degree | 41.3 degree | Standard Deviation 2.9 |
Secondary
Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 3 Months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIS Stem | Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component) | Neutral | 20 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component) | Valgus | 0 Participants |
Secondary
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip
Time frame: 3 Months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | No Problems on Checklist | Yes | 20 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | No Problems on Checklist | No | 0 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Acetabular Component Position Degree | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Acetabular Component Position Degree | No | 20 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Stem Subsidence | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Stem Subsidence | No | 20 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Evidence of Acetabular Component Failure | No | 20 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Evidence of Femoral Component Failure | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Evidence of Femoral Component Failure | No | 20 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Brooker Classification | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Brooker Classification | No | 20 Participants |
Secondary
Radiographic Assessment at 5 Year Visit
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 5 Year
Population: All available subjects participating in this time point visit assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Radiographic Assessment at 5 Year Visit | Femoral Valgus Position Degree | 10.5 degree | Standard Deviation 2.12 |
| MIS Stem | Radiographic Assessment at 5 Year Visit | Acetabular Component Position Degree | 40.6 degree | Standard Deviation 3.41 |
Secondary
Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: 5 Years
Population: All available subjects participating in this time point visit assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIS Stem | Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component) | Neutral | 8 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component) | Valgus | 2 Participants |
Secondary
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip
Time frame: 5 Year
Population: All participants available at this time point visit assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | No Problems on Checklist | Yes | 10 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | No Problems on Checklist | No | 0 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Acetabular Component Position Degree | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Acetabular Component Position Degree | No | 10 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Stem Subsidence | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Stem Subsidence | No | 10 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Evidence of Acetabular Component Failure | No | 10 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Evidence of Femoral Component Failure | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Evidence of Femoral Component Failure | No | 10 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Brooker Classification | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Brooker Classification | No | 10 Participants |
Secondary
Radiographic Assessment at Discharge Visit
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: Discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIS Stem | Radiographic Assessment at Discharge Visit | Femoral Valgus Position Degree | 0 degree | Standard Deviation 0 |
| MIS Stem | Radiographic Assessment at Discharge Visit | Acetabular Component Position Degree | 40.9 degree | Standard Deviation 3.44 |
Secondary
Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time frame: Discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIS Stem | Radiographic Assessment at Discharge Visit (Neutral/Valgus Component) | Neutral | 20 Participants |
| MIS Stem | Radiographic Assessment at Discharge Visit (Neutral/Valgus Component) | Valgus | 0 Participants |
Secondary
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip
Time frame: Discharge
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | No Problems on Checklist | Yes | 20 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | No Problems on Checklist | No | 0 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Acetabular Component Position Degree | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Acetabular Component Position Degree | No | 20 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Stem Subsidence | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Stem Subsidence | No | 20 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Evidence of Acetabular Component Failure | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Evidence of Acetabular Component Failure | No | 20 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Evidence of Femoral Component Failure | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Evidence of Femoral Component Failure | No | 20 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Brooker Classification | Yes | 0 Participants |
| MIS Stem | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Brooker Classification | No | 20 Participants |