Trial Outcomes & Findings for Mini Stem DEXA (Dual Energy X-ray Absorptiometry) (NCT NCT01066936)
NCT ID: NCT01066936
Last Updated: 2020-03-06
Results Overview
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.
COMPLETED
20 participants
Preoperative
2020-03-06
Participant Flow
This study was conducted by 1 investigator in 1 country from 14 Sep 2009 to 18 Apr 2016.
A total of 22 subjects were screened, with 20 subjects enrolled and had surgery/MIS implanted.
Unit of analysis: hips
Participant milestones
| Measure |
MIS (Mini Stem) 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. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during total hip arthroplasty (THA).
|
|---|---|
|
Overall Study
STARTED
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20 20
|
|
Overall Study
COMPLETED
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10 10
|
|
Overall Study
NOT COMPLETED
|
10 10
|
Reasons for withdrawal
| Measure |
MIS (Mini Stem) 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. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during total hip arthroplasty (THA).
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Device revised/removed
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
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Overall Study
Withdrawal by Subject
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4
|
Baseline Characteristics
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
Baseline characteristics by cohort
| Measure |
MIS Stem
n=20 Participants
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.
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|---|---|
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Age, Continuous
|
64.8 years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
European
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=5 Participants
|
|
Height
|
170.2 cm
STANDARD_DEVIATION 7.39 • n=5 Participants
|
|
Weight
|
90.8 kg
STANDARD_DEVIATION 12.39 • n=5 Participants
|
|
Body Mass Index (BMI)
|
31.3 kg/m^2
STANDARD_DEVIATION 3.69 • n=5 Participants
|
|
Primary Diagnosis Charnley Classification
Avascular necrosis: B1 Bilateral Hip Joint Disease
|
1 Participants
n=5 Participants
|
|
Primary Diagnosis Charnley Classification
Osteoarthritis: A Unilateral Hip Joint Disease
|
14 Participants
n=5 Participants
|
|
Primary Diagnosis Charnley Classification
Osteoarthritis: B1 Bilateral Hip Joint Disease
|
4 Participants
n=5 Participants
|
|
Primary Diagnosis Charnley Classification
Rheumatoid arthritis:C1 Multi-joint arthroplasties
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PreoperativeDEXA=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.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
DEXA Analysis of BMD at Preoperative Visit
Femoral Region 1
|
0.8 g/cm^2
Standard Deviation 0.22
|
|
DEXA Analysis of BMD at Preoperative Visit
Femoral Region 2
|
1.0 g/cm^2
Standard Deviation 0.25
|
|
DEXA Analysis of BMD at Preoperative Visit
Femoral Region 3
|
1.6 g/cm^2
Standard Deviation 0.31
|
|
DEXA Analysis of BMD at Preoperative Visit
Femoral Region 4
|
2.0 g/cm^2
Standard Deviation 0.32
|
|
DEXA Analysis of BMD at Preoperative Visit
Femoral Region 5
|
1.8 g/cm^2
Standard Deviation 0.33
|
|
DEXA Analysis of BMD at Preoperative Visit
Femoral Region 6
|
1.3 g/cm^2
Standard Deviation 0.29
|
|
DEXA Analysis of BMD at Preoperative Visit
Femoral Region 7
|
1.4 g/cm^2
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: 3 MonthsDEXA=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.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
DEXA Analysis of BMD at 3 Months
Femoral Region 1
|
0.8 g/cm^2
Standard Deviation 0.18
|
|
DEXA Analysis of BMD at 3 Months
Femoral Region 2
|
1.3 g/cm^2
Standard Deviation 0.26
|
|
DEXA Analysis of BMD at 3 Months
Femoral Region 3
|
2.1 g/cm^2
Standard Deviation 0.39
|
|
DEXA Analysis of BMD at 3 Months
Femoral Region 4
|
1.9 g/cm^2
Standard Deviation 0.27
|
|
DEXA Analysis of BMD at 3 Months
Femoral Region 5
|
1.9 g/cm^2
Standard Deviation 0.27
|
|
DEXA Analysis of BMD at 3 Months
Femoral Region 6
|
1.5 g/cm^2
Standard Deviation 0.32
|
|
DEXA Analysis of BMD at 3 Months
Femoral Region 7
|
1.3 g/cm^2
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: 6 MonthsDEXA=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.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
DEXA Analysis of BMD at 6 Months
Femoral Region 1
|
0.8 g/cm^2
Standard Deviation 0.19
|
|
DEXA Analysis of BMD at 6 Months
Femoral Region 2
|
1.3 g/cm^2
Standard Deviation 0.31
|
|
DEXA Analysis of BMD at 6 Months
Femoral Region 3
|
2.1 g/cm^2
Standard Deviation 0.38
|
|
DEXA Analysis of BMD at 6 Months
Femoral Region 4
|
1.9 g/cm^2
Standard Deviation 0.30
|
|
DEXA Analysis of BMD at 6 Months
Femoral Region 5
|
2.0 g/cm^2
Standard Deviation 0.28
|
|
DEXA Analysis of BMD at 6 Months
Femoral Region 6
|
1.6 g/cm^2
Standard Deviation 0.30
|
|
DEXA Analysis of BMD at 6 Months
Femoral Region 7
|
1.2 g/cm^2
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: 1 YearDEXA=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.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
DEXA Analysis of BMD at 1 Year
Femoral Region 1
|
0.8 g/cm^2
Standard Deviation 0.20
|
|
DEXA Analysis of BMD at 1 Year
Femoral Region 2
|
1.3 g/cm^2
Standard Deviation 0.29
|
|
DEXA Analysis of BMD at 1 Year
Femoral Region 3
|
2.1 g/cm^2
Standard Deviation 0.41
|
|
DEXA Analysis of BMD at 1 Year
Femoral Region 4
|
1.9 g/cm^2
Standard Deviation 0.30
|
|
DEXA Analysis of BMD at 1 Year
Femoral Region 5
|
1.9 g/cm^2
Standard Deviation 0.31
|
|
DEXA Analysis of BMD at 1 Year
Femoral Region 6
|
1.6 g/cm^2
Standard Deviation 0.37
|
|
DEXA Analysis of BMD at 1 Year
Femoral Region 7
|
1.3 g/cm^2
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: 2 YearDEXA=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.
Outcome measures
| Measure |
MIS Stem
n=19 Participants
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.
|
|---|---|
|
DEXA Analysis of BMD at 2 Years
Femoral Region 1
|
0.8 g/cm^2
Standard Deviation 0.21
|
|
DEXA Analysis of BMD at 2 Years
Femoral Region 2
|
1.3 g/cm^2
Standard Deviation 0.33
|
|
DEXA Analysis of BMD at 2 Years
Femoral Region 3
|
2.2 g/cm^2
Standard Deviation 0.31
|
|
DEXA Analysis of BMD at 2 Years
Femoral Region 4
|
1.9 g/cm^2
Standard Deviation 0.29
|
|
DEXA Analysis of BMD at 2 Years
Femoral Region 5
|
2.0 g/cm^2
Standard Deviation 0.32
|
|
DEXA Analysis of BMD at 2 Years
Femoral Region 6
|
1.6 g/cm^2
Standard Deviation 0.39
|
|
DEXA Analysis of BMD at 2 Years
Femoral Region 7
|
1.3 g/cm^2
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: PreoperativeThe 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.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Baseline Harris Hip Score (HHS) at Preoperative Visit
Pain
|
17.0 score on a scale
Standard Deviation 7.33
|
|
Baseline Harris Hip Score (HHS) at Preoperative Visit
Function
|
26.0 score on a scale
Standard Deviation 7.58
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|
Baseline Harris Hip Score (HHS) at Preoperative Visit
Absence of Deformity
|
3.8 score on a scale
Standard Deviation 0.89
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|
Baseline Harris Hip Score (HHS) at Preoperative Visit
Range of Motion
|
2.7 score on a scale
Standard Deviation 0.86
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Baseline Harris Hip Score (HHS) at Preoperative Visit
Total
|
49.5 score on a scale
Standard Deviation 13.53
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SECONDARY outcome
Timeframe: 3 MonthPopulation: Overall number of participants analyzed was 20 particpants; however, for the Function and Total Overall portion of the questionnaire only 18 participants responded.
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.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Harris Hip Score (HHS) at 3 Month Visit
Pain
|
37.5 score on a scale
Standard Deviation 9.56
|
|
Harris Hip Score (HHS) at 3 Month Visit
Function
|
35.1 score on a scale
Standard Deviation 5.60
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|
Harris Hip Score (HHS) at 3 Month Visit
Absence of Deformity
|
4.0 score on a scale
Standard Deviation 0.00
|
|
Harris Hip Score (HHS) at 3 Month Visit
Range of Motion
|
4.1 score on a scale
Standard Deviation 0.69
|
|
Harris Hip Score (HHS) at 3 Month Visit
Total
|
82.6 score on a scale
Standard Deviation 10.15
|
SECONDARY outcome
Timeframe: 6 MonthsThe 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.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Harris Hip Score (HHS) at 6 Month Visit
Pain
|
40.8 score on a scale
Standard Deviation 5.29
|
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Harris Hip Score (HHS) at 6 Month Visit
Function
|
41.2 score on a scale
Standard Deviation 5.67
|
|
Harris Hip Score (HHS) at 6 Month Visit
Absence of Deformity
|
4.0 score on a scale
Standard Deviation 0.00
|
|
Harris Hip Score (HHS) at 6 Month Visit
Range of Motion
|
4.2 score on a scale
Standard Deviation 0.37
|
|
Harris Hip Score (HHS) at 6 Month Visit
Total
|
90.1 score on a scale
Standard Deviation 7.22
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Two subjects were missing results from the study site for the HHS.
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.
Outcome measures
| Measure |
MIS Stem
n=17 Participants
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.
|
|---|---|
|
Harris Hip Score (HHS) at 1 Year Visit
Pain
|
38.0 score on a scale
Standard Deviation 9.27
|
|
Harris Hip Score (HHS) at 1 Year Visit
Function
|
41.5 score on a scale
Standard Deviation 7.14
|
|
Harris Hip Score (HHS) at 1 Year Visit
Absence of Deformity
|
4.0 score on a scale
Standard Deviation 0.00
|
|
Harris Hip Score (HHS) at 1 Year Visit
Range of Motion
|
4.5 score on a scale
Standard Deviation 0.62
|
|
Harris Hip Score (HHS) at 1 Year Visit
Total
|
87.3 score on a scale
Standard Deviation 16.13
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Number of participants returning for this time point visit assessment.
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.
Outcome measures
| Measure |
MIS Stem
n=11 Participants
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.
|
|---|---|
|
Harris Hip Score (HHS) at 2 Year Visit
Pain
|
40.7 score on a scale
Standard Deviation 7.11
|
|
Harris Hip Score (HHS) at 2 Year Visit
Function
|
41.9 score on a scale
Standard Deviation 5.79
|
|
Harris Hip Score (HHS) at 2 Year Visit
Absence of Deformity
|
4.0 score on a scale
Standard Deviation 0.00
|
|
Harris Hip Score (HHS) at 2 Year Visit
Range of Motion
|
4.0 score on a scale
Standard Deviation 0.45
|
|
Harris Hip Score (HHS) at 2 Year Visit
Total
|
90.6 score on a scale
Standard Deviation 11.57
|
SECONDARY outcome
Timeframe: 5 YearPopulation: Number of participants returning for this time point visit assessment.
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.
Outcome measures
| Measure |
MIS Stem
n=9 Participants
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.
|
|---|---|
|
Harris Hip Score (HHS) at 5 Year Visit
Pain
|
43.6 score on a scale
Standard Deviation 1.33
|
|
Harris Hip Score (HHS) at 5 Year Visit
Function
|
45.8 score on a scale
Standard Deviation 1.48
|
|
Harris Hip Score (HHS) at 5 Year Visit
Absence of Deformity
|
4.0 score on a scale
Standard Deviation 0.00
|
|
Harris Hip Score (HHS) at 5 Year Visit
Range of Motion
|
4.3 score on a scale
Standard Deviation 0.50
|
|
Harris Hip Score (HHS) at 5 Year Visit
Total
|
97.7 score on a scale
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: PreoperativeThe 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.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
Pain
|
49.1 score on a scale
Standard Deviation 17.50
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
Daily Living
|
44.7 score on a scale
Standard Deviation 17.19
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
Sports/Recreational Activities
|
22.1 score on a scale
Standard Deviation 19.98
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
Quality of Life
|
24.7 score on a scale
Standard Deviation 14.97
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
Symptoms and Stiffness
|
52.8 score on a scale
Standard Deviation 18.53
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: Information was not provided from the study site for two subjects in the HOOS Sports/Recreational Activities (0-100) category.
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.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
Symptoms and Stiffness
|
83.0 score on a scale
Standard Deviation 13.42
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
Pain
|
88.8 score on a scale
Standard Deviation 13.39
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
Daily Living
|
84.8 score on a scale
Standard Deviation 12.29
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
Sports/Recreational Activities
|
76.0 score on a scale
Standard Deviation 22.70
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
Quality of Life
|
73.1 score on a scale
Standard Deviation 22.86
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Information was not provided from the study site for two subjects in the HOOS Sports/Recreational Activities (0-100) category.
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.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
Symptoms and Stiffness
|
93.0 score on a scale
Standard Deviation 10.31
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
Pain
|
94.2 score on a scale
Standard Deviation 7.82
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
Daily Living
|
93.0 score on a scale
Standard Deviation 6.80
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
Sports/Recreational Activities
|
80.4 score on a scale
Standard Deviation 17.37
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
Quality of Life
|
83.8 score on a scale
Standard Deviation 14.68
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Number of participants returning for this time point visit assessment.
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.
Outcome measures
| Measure |
MIS Stem
n=16 Participants
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.
|
|---|---|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
Symptoms and Stiffness
|
90.0 score on a scale
Standard Deviation 14.14
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
Pain
|
89.2 score on a scale
Standard Deviation 14.54
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
Daily Living
|
87.8 score on a scale
Standard Deviation 15.62
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
Sports/Recreational Activities
|
78.3 score on a scale
Standard Deviation 28.8
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
Quality of Life
|
82.4 score on a scale
Standard Deviation 25.13
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: 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.
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.
Outcome measures
| Measure |
MIS Stem
n=14 Participants
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.
|
|---|---|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
Symptoms and Stiffness
|
90.7 score on a scale
Standard Deviation 8.05
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
Pain
|
92.5 score on a scale
Standard Deviation 10.28
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
Daily Living
|
89.9 score on a scale
Standard Deviation 12.54
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
Sports/Recreational Activities
|
81.6 score on a scale
Standard Deviation 20.60
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
Quality of Life
|
81.7 score on a scale
Standard Deviation 22.74
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: 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.
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.
Outcome measures
| Measure |
MIS Stem
n=10 Participants
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.
|
|---|---|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
Symptoms and Stiffness
|
96.5 score on a scale
Standard Deviation 6.69
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
Pain
|
98.3 score on a scale
Standard Deviation 4.15
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
Daily Living
|
97.2 score on a scale
Standard Deviation 5.27
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
Sports/Recreational Activities
|
85.6 score on a scale
Standard Deviation 21.91
|
|
Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
Quality of Life
|
95.8 score on a scale
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: DischargeRadiographs 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
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
No Problems on Checklist · Yes
|
20 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
No Problems on Checklist · No
|
0 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Acetabular Component Position Degree · Yes
|
0 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Acetabular Component Position Degree · No
|
20 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Stem Subsidence · Yes
|
0 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Stem Subsidence · No
|
20 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Evidence of Acetabular Component Failure · Yes
|
0 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Evidence of Acetabular Component Failure · No
|
20 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Evidence of Femoral Component Failure · Yes
|
0 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Evidence of Femoral Component Failure · No
|
20 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Brooker Classification · Yes
|
0 Participants
|
|
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Brooker Classification · No
|
20 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsRadiographs 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
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
No Problems on Checklist · Yes
|
20 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
No Problems on Checklist · No
|
0 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Acetabular Component Position Degree · Yes
|
0 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Acetabular Component Position Degree · No
|
20 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Stem Subsidence · Yes
|
0 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Stem Subsidence · No
|
20 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Evidence of Acetabular Component Failure · Yes
|
0 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Evidence of Acetabular Component Failure · No
|
20 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Evidence of Femoral Component Failure · Yes
|
0 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Evidence of Femoral Component Failure · No
|
20 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Brooker Classification · Yes
|
0 Participants
|
|
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Brooker Classification · No
|
20 Participants
|
SECONDARY outcome
Timeframe: 1 YearRadiographs 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
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
No Problems on Checklist · Yes
|
19 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
No Problems on Checklist · No
|
1 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Acetabular Component Position Degree · Yes
|
0 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Acetabular Component Position Degree · No
|
20 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Stem Subsidence · Yes
|
1 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Stem Subsidence · No
|
19 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Evidence of Acetabular Component Failure · Yes
|
0 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Evidence of Acetabular Component Failure · No
|
20 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Evidence of Femoral Component Failure · Yes
|
0 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Evidence of Femoral Component Failure · No
|
20 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Brooker Classification · Yes
|
0 Participants
|
|
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Brooker Classification · No
|
20 Participants
|
SECONDARY outcome
Timeframe: 5 YearPopulation: All participants available at this time point visit assessment.
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
Outcome measures
| Measure |
MIS Stem
n=10 Participants
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.
|
|---|---|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
No Problems on Checklist · Yes
|
10 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
No Problems on Checklist · No
|
0 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Acetabular Component Position Degree · Yes
|
0 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Acetabular Component Position Degree · No
|
10 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Stem Subsidence · Yes
|
0 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Stem Subsidence · No
|
10 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Evidence of Acetabular Component Failure · Yes
|
0 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Evidence of Acetabular Component Failure · No
|
10 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Evidence of Femoral Component Failure · Yes
|
0 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Evidence of Femoral Component Failure · No
|
10 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Brooker Classification · Yes
|
0 Participants
|
|
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Brooker Classification · No
|
10 Participants
|
SECONDARY outcome
Timeframe: DischargeRadiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Radiographic Assessment at Discharge Visit
Femoral Valgus Position Degree
|
0 degree
Standard Deviation 0
|
|
Radiographic Assessment at Discharge Visit
Acetabular Component Position Degree
|
40.9 degree
Standard Deviation 3.44
|
SECONDARY outcome
Timeframe: 3 MonthsRadiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Radiographic Assessment at 3 Month Visit
Femoral Valgus Position Degree
|
0 degree
Standard Deviation 0
|
|
Radiographic Assessment at 3 Month Visit
Acetabular Component Position Degree
|
41.3 degree
Standard Deviation 2.90
|
SECONDARY outcome
Timeframe: 1 YearRadiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Radiographic Assessment at 1 Year Visit
Femoral Valgus Position Degree
|
0 degree
Standard Deviation 0
|
|
Radiographic Assessment at 1 Year Visit
Acetabular Component Position Degree
|
41.3 degree
Standard Deviation 2.90
|
SECONDARY outcome
Timeframe: 5 YearPopulation: All available subjects participating in this time point visit assessment.
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Radiographic Assessment at 5 Year Visit
Femoral Valgus Position Degree
|
10.5 degree
Standard Deviation 2.12
|
|
Radiographic Assessment at 5 Year Visit
Acetabular Component Position Degree
|
40.6 degree
Standard Deviation 3.41
|
SECONDARY outcome
Timeframe: DischargeRadiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)
Neutral
|
20 Participants
|
|
Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)
Valgus
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsRadiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)
Neutral
|
20 Participants
|
|
Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)
Valgus
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 YearRadiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Stem
n=20 Participants
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.
|
|---|---|
|
Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)
Neutral
|
20 Participants
|
|
Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)
Valgus
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: All available subjects participating in this time point visit assessment.
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Outcome measures
| Measure |
MIS Stem
n=10 Participants
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.
|
|---|---|
|
Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)
Neutral
|
8 Participants
|
|
Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)
Valgus
|
2 Participants
|
Adverse Events
MIS Stem
Serious adverse events
| Measure |
MIS Stem
n=20 participants at risk
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. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
|
|---|---|
|
General disorders
Death
|
10.0%
2/20 • Number of events 2 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Congenital, familial and genetic disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Injury, poisoning and procedural complications
Cut hand - hospital admission for intervenous (IV) antibiotics
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Contralateral THR secondary to osteoarthritis (OA)
|
10.0%
2/20 • Number of events 2 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Unicompartmental knee replacement secondary to OA
|
10.0%
2/20 • Number of events 3 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Gastrointestinal disorders
Cholecystectomy
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Nervous system disorders
Alzheimer's Disease
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Product Issues
Subsidence of femoral prosthesis; revision in THR
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Product Issues
Dislocation THR
|
5.0%
1/20 • Number of events 2 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Gastrointestinal disorders
Bleeding gastric ulcer
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis region 1, 3-7 on radiograph
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Injury, poisoning and procedural complications
Pain on weight-bearing lower thigh
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
Other adverse events
| Measure |
MIS Stem
n=20 participants at risk
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. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
|
|---|---|
|
Cardiac disorders
Paroxysmal Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Cortical thickening region 3
|
55.0%
11/20 • Number of events 11 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Metabolism and nutrition disorders
Newly diagnosed hypoparathyroidism
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Mild sclerosis over weight-bearing aspect of acetabulum on x-ray
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Adductor tendonitis
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
10.0%
2/20 • Number of events 2 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Injury, poisoning and procedural complications
Sprained Adductors
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Thigh and trochanteric pain
|
10.0%
2/20 • Number of events 2 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Condensation around tip of stem on x-ray femur
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
|
Musculoskeletal and connective tissue disorders
Trochanteric pain
|
5.0%
1/20 • Number of events 1 • The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60