Trial Outcomes & Findings for Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA) (NCT NCT01183260)
NCT ID: NCT01183260
Last Updated: 2017-11-07
Results Overview
Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned.
COMPLETED
NA
25 participants
2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative
2017-11-07
Participant Flow
Recruitment period: 2010 - 2014
Participant milestones
| Measure |
Zimmer Trabecular Metal Acetabular Cup
Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
|
Zimmer Modular Cup
Zimmer Modular Cup: Revision of the acetabular cup
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Zimmer Trabecular Metal Acetabular Cup
Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
|
Zimmer Modular Cup
Zimmer Modular Cup: Revision of the acetabular cup
|
|---|---|---|
|
Overall Study
Intraop screen failure
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Revised within 30 days
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Zimmer Trabecular Metal Acetabular Cup
n=10 Participants
Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
|
Zimmer Modular Cup
n=9 Participants
Zimmer Modular Cup: Revision of the acetabular cup
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.60 years
STANDARD_DEVIATION 11.40 • n=10 Participants
|
61.11 years
STANDARD_DEVIATION 9.74 • n=9 Participants
|
59.79 years
STANDARD_DEVIATION 10.15 • n=19 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
5 Participants
n=9 Participants
|
9 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
4 Participants
n=9 Participants
|
10 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
19 Participants
n=19 Participants
|
|
Operative Side: Left, Right
Left
|
5 Participants
n=10 Participants
|
5 Participants
n=9 Participants
|
10 Participants
n=19 Participants
|
|
Operative Side: Left, Right
Right
|
5 Participants
n=10 Participants
|
4 Participants
n=9 Participants
|
9 Participants
n=19 Participants
|
|
BMI (kg/m^2), Continuous
|
30.14 kg/m^2
STANDARD_DEVIATION 6.07 • n=10 Participants
|
30.49 kg/m^2
STANDARD_DEVIATION 7.56 • n=9 Participants
|
30.31 kg/m^2
STANDARD_DEVIATION 6.44 • n=19 Participants
|
PRIMARY outcome
Timeframe: 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperativePopulation: By Year 2, there were 3 patients lost to follow-up in the Revision Cup group and 3 patients lost to follow-up in the Modular Cup group: We were unable to contact 1 patient from each group in order to schedule follow-up The remaining patients were withdrawn because they were feeling fine and declined to return for follow-up at that time
Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned.
Outcome measures
| Measure |
Zimmer Trabecular Metal Acetabular Cup
n=10 Participants
Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
|
Zimmer Modular Cup
n=9 Participants
Zimmer Modular Cup: Revision of the acetabular cup
|
|---|---|---|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
3 Month - Region 2
|
1.85 g/cm^2
Standard Deviation 0.34
|
1.64 g/cm^2
Standard Deviation 0.31
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
3 Month - Region 1
|
1.63 g/cm^2
Standard Deviation 0.42
|
1.64 g/cm^2
Standard Deviation 0.38
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
3 Month - Region 3
|
1.27 g/cm^2
Standard Deviation 0.33
|
0.92 g/cm^2
Standard Deviation 0.31
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
3 Month - Lumbar Spine (L1-L4)
|
1.29 g/cm^2
Standard Deviation 0.15
|
1.21 g/cm^2
Standard Deviation 0.18
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
6 Month - Region 1
|
1.61 g/cm^2
Standard Deviation 0.18
|
1.82 g/cm^2
Standard Deviation 0.28
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
6 Month - Region 2
|
1.75 g/cm^2
Standard Deviation 0.31
|
1.76 g/cm^2
Standard Deviation 0.33
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
6 Month - Region 3
|
1.22 g/cm^2
Standard Deviation 0.30
|
0.94 g/cm^2
Standard Deviation 0.30
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
6 Month - Lumbar Spine (L1-L4)
|
1.29 g/cm^2
Standard Deviation 0.17
|
1.22 g/cm^2
Standard Deviation 0.16
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
1 Year - Region 1
|
1.64 g/cm^2
Standard Deviation 0.17
|
1.84 g/cm^2
Standard Deviation 0.34
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
1 Year - Region 2
|
1.82 g/cm^2
Standard Deviation 0.28
|
1.72 g/cm^2
Standard Deviation 0.41
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
1 Year - Region 3
|
1.23 g/cm^2
Standard Deviation 0.14
|
1.22 g/cm^2
Standard Deviation 0.16
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
1 Year - Lumbar Spine (L1-L4)
|
1.26 g/cm^2
Standard Deviation 0.14
|
1.22 g/cm^2
Standard Deviation 0.16
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
2 Year - Region 1
|
1.75 g/cm^2
Standard Deviation 0.23
|
1.93 g/cm^2
Standard Deviation 0.45
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
2 Year - Region 2
|
1.76 g/cm^2
Standard Deviation 0.24
|
1.83 g/cm^2
Standard Deviation 0.71
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
2 Year - Region 3
|
1.19 g/cm^2
Standard Deviation 0.24
|
1.00 g/cm^2
Standard Deviation 0.36
|
|
Periprosthetic Bone Mineral Density (BMD) of Hip
2 Year - Lumbar Spine (L1-L4)
|
1.26 g/cm^2
Standard Deviation 0.14
|
1.15 g/cm^2
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: 2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperativePopulation: By Year 2, there were 3 patients lost to follow-up in the Revision Cup group and 3 patients lost to follow-up in the Modular Cup group: We were unable to contact 1 patient from each group in order to schedule follow-up
Analyze and compare functional and general health outcomes of these patients, based on Hip disability and Osteoarthritis Outcomes Score (HOOS) and 12-item Short Form Health Survey (SF-12v2). All subscale scores are calculated independently and range from 0 to 100, where 100 indicates no problems: * SF-12 Physical Component Summary Subscale (SF12 PCS) assesses physical function, bodily pain, and general health. * SF-12 Mental Component Summary Subscale (SF12 MCS) assesses emotional and mental health. * HOOS Pain assesses pain in the hip * HOOS Symptoms assesses symptoms such as stiffness in the hip * HOOS activities of daily living (HOOS ADL) assesses physical function while performing common daily activities (walking, sitting, standing, etc.) * HOOS sport and recreation (HOOS Sports/Rec) assesses physical function while performing higher-level activities (running, squatting, etc.) * HOOS hip-related quality of life (HOOS QOL) assesses how much the hip impacts life
Outcome measures
| Measure |
Zimmer Trabecular Metal Acetabular Cup
n=10 Participants
Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
|
Zimmer Modular Cup
n=9 Participants
Zimmer Modular Cup: Revision of the acetabular cup
|
|---|---|---|
|
Functional and General Health Outcome Assessments
6 Month HOOS Pain
|
61.94 units on a scale
Standard Deviation 19.07
|
81.94 units on a scale
Standard Deviation 14.02
|
|
Functional and General Health Outcome Assessments
6 Month HOOS Symptoms
|
58.33 units on a scale
Standard Deviation 17.68
|
76.67 units on a scale
Standard Deviation 19.04
|
|
Functional and General Health Outcome Assessments
6 Month HOOS ADL
|
55.56 units on a scale
Standard Deviation 15.71
|
76.79 units on a scale
Standard Deviation 17.15
|
|
Functional and General Health Outcome Assessments
6 Month HOOS Sports/Rec
|
26.39 units on a scale
Standard Deviation 18.00
|
46.13 units on a scale
Standard Deviation 29.98
|
|
Functional and General Health Outcome Assessments
1 Year HOOS Symptoms
|
63.75 units on a scale
Standard Deviation 30.68
|
75.83 units on a scale
Standard Deviation 18.03
|
|
Functional and General Health Outcome Assessments
1 Year HOOS Sports/Rec
|
20.49 units on a scale
Standard Deviation 20.68
|
51.49 units on a scale
Standard Deviation 19.79
|
|
Functional and General Health Outcome Assessments
1 Year HOOS QOL
|
38.89 units on a scale
Standard Deviation 31.98
|
56.79 units on a scale
Standard Deviation 37.45
|
|
Functional and General Health Outcome Assessments
2 Year HOOS Pain
|
69.64 units on a scale
Standard Deviation 26.71
|
82.92 units on a scale
Standard Deviation 24.41
|
|
Functional and General Health Outcome Assessments
2 Year HOOS Symptoms
|
65.54 units on a scale
Standard Deviation 23.98
|
70.00 units on a scale
Standard Deviation 29.83
|
|
Functional and General Health Outcome Assessments
2 Year HOOS ADL
|
66.19 units on a scale
Standard Deviation 26.93
|
77.38 units on a scale
Standard Deviation 18.65
|
|
Functional and General Health Outcome Assessments
2 Year HOOS Sports/Rec
|
39.58 units on a scale
Standard Deviation 25.43
|
65.83 units on a scale
Standard Deviation 20.92
|
|
Functional and General Health Outcome Assessments
2 Year HOOS QOL
|
60.32 units on a scale
Standard Deviation 29.99
|
62.96 units on a scale
Standard Deviation 24.00
|
|
Functional and General Health Outcome Assessments
Preop SF12 PCS
|
32.25 units on a scale
Standard Deviation 5.86
|
38.57 units on a scale
Standard Deviation 12.07
|
|
Functional and General Health Outcome Assessments
Preop SF12 MCS
|
55.29 units on a scale
Standard Deviation 8.07
|
47.62 units on a scale
Standard Deviation 10.39
|
|
Functional and General Health Outcome Assessments
3 Month SF12 PCS
|
32.25 units on a scale
Standard Deviation 8.38
|
38.57 units on a scale
Standard Deviation 11.63
|
|
Functional and General Health Outcome Assessments
3 Month SF12 MCS
|
51.78 units on a scale
Standard Deviation 8.10
|
51.09 units on a scale
Standard Deviation 9.45
|
|
Functional and General Health Outcome Assessments
6 Month SF12 PCS
|
32.14 units on a scale
Standard Deviation 7.22
|
40.12 units on a scale
Standard Deviation 13.00
|
|
Functional and General Health Outcome Assessments
6 Month SF12 MCS
|
50.51 units on a scale
Standard Deviation 11.53
|
52.83 units on a scale
Standard Deviation 7.70
|
|
Functional and General Health Outcome Assessments
1 Year SF12 PCS
|
31.04 units on a scale
Standard Deviation 12.54
|
42.84 units on a scale
Standard Deviation 16.14
|
|
Functional and General Health Outcome Assessments
1 Year SF12 MCS
|
55.58 units on a scale
Standard Deviation 10.18
|
54.04 units on a scale
Standard Deviation 8.64
|
|
Functional and General Health Outcome Assessments
2 Year SF12 PCS
|
36.10 units on a scale
Standard Deviation 11.39
|
47.05 units on a scale
Standard Deviation 13.52
|
|
Functional and General Health Outcome Assessments
2 Year SF12 MCS
|
53.46 units on a scale
Standard Deviation 7.93
|
48.66 units on a scale
Standard Deviation 11.24
|
|
Functional and General Health Outcome Assessments
Preop HOOS Pain
|
50.25 units on a scale
Standard Deviation 20.19
|
36.67 units on a scale
Standard Deviation 25.19
|
|
Functional and General Health Outcome Assessments
Preop HOOS Symptoms
|
46.50 units on a scale
Standard Deviation 18.72
|
38.33 units on a scale
Standard Deviation 27.95
|
|
Functional and General Health Outcome Assessments
Preop HOOS ADL
|
39.48 units on a scale
Standard Deviation 8.63
|
32.11 units on a scale
Standard Deviation 31.24
|
|
Functional and General Health Outcome Assessments
Preop HOOS Sports/Rec
|
8.75 units on a scale
Standard Deviation 12.96
|
15.28 units on a scale
Standard Deviation 21.40
|
|
Functional and General Health Outcome Assessments
Preop HOOS QOL
|
28.89 units on a scale
Standard Deviation 31.95
|
27.16 units on a scale
Standard Deviation 25.53
|
|
Functional and General Health Outcome Assessments
3 Month HOOS Pain
|
61.50 units on a scale
Standard Deviation 16.72
|
76.39 units on a scale
Standard Deviation 17.37
|
|
Functional and General Health Outcome Assessments
3 Month HOOS Symptoms
|
55.50 units on a scale
Standard Deviation 19.50
|
66.67 units on a scale
Standard Deviation 18.03
|
|
Functional and General Health Outcome Assessments
3 Month HOOS ADL
|
52.45 units on a scale
Standard Deviation 14.23
|
66.81 units on a scale
Standard Deviation 17.09
|
|
Functional and General Health Outcome Assessments
3 Month HOOS Sports/Rec
|
21.88 units on a scale
Standard Deviation 16.39
|
29.17 units on a scale
Standard Deviation 15.80
|
|
Functional and General Health Outcome Assessments
3 Month HOOS QOL
|
28.89 units on a scale
Standard Deviation 16.73
|
49.38 units on a scale
Standard Deviation 30.99
|
|
Functional and General Health Outcome Assessments
6 Month HOOS QOL
|
37.04 units on a scale
Standard Deviation 23.57
|
49.38 units on a scale
Standard Deviation 37.31
|
|
Functional and General Health Outcome Assessments
1 Year HOOS Pain
|
61.88 units on a scale
Standard Deviation 27.57
|
81.67 units on a scale
Standard Deviation 12.18
|
|
Functional and General Health Outcome Assessments
1 Year HOOS ADL
|
56.88 units on a scale
Standard Deviation 26.80
|
76.88 units on a scale
Standard Deviation 17.77
|
Adverse Events
Zimmer Trabecular Metal Acetabular Cup
Zimmer Modular Cup
Serious adverse events
| Measure |
Zimmer Trabecular Metal Acetabular Cup
n=14 participants at risk
Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup
|
Zimmer Modular Cup
n=11 participants at risk
Zimmer Modular Cup: Revision of the acetabular cup
|
|---|---|---|
|
Surgical and medical procedures
Revision surgery due to multiple dislocations
|
0.00%
0/14 • 2 Years
|
9.1%
1/11 • Number of events 1 • 2 Years
|
Other adverse events
Adverse event data not reported
Additional Information
Alison Klika, Research Program Manager
Cleveland Clinic
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place