Accolade® TMZF® Hip Stem Outcomes Study
Sponsor
Stryker Orthopaedics (Industry)
Overall Status
Completed
CT.gov ID
NCT00957658
Collaborator
(none)
241
11
1
98
21.9
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A prospective, post-market, multi-centered clinical evaluation of the Accolade® TMZF® hip stem device. All patients enrolled will receive the study device. All study patients will undergo a preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone mineral density (BMD) values.
Study Design
Study Type:
Interventional
Actual Enrollment
:
241 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Accolade® TMZF® Study A Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade® TMZF® Hip Stem
Study Start Date
:
Mar 1, 2006
Actual Primary Completion Date
:
May 1, 2011
Actual Study Completion Date
:
May 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Accolade® TMZF® Hip Stem Accolade® TMZF® Hip Stem Study Device |
Device: Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem
|
Outcome Measures
Primary Outcome Measures
- Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain [2 years]
Secondary Outcome Measures
- Percentage (%) of Hip Stems With Aseptic Loosening [5 years]
Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view.
- Revision/Removal Rates [2 and 5 years]
The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals.
- Change in Harris Hip Score (HHS) [Preoperative, 2 and 5 years]
The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.
- Change in SF-12 Score [Preoperative, 2 and 5 years]
The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
- Change in Lower Extremity Activity Scale (LEAS) Score [Preoperative, 2 and 5 years]
The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement.
- PEQ (Patient Expectation Questionnaire) Overall Satisfaction [6 months, 1 year and 2 years]
The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement. EXPECTATIONS KEY: Participate in recreational activities (dancing,traveling,gardening) Exercise or participate in sports Independently perform household chores/daily routine Easily change position,sit to stand/stand to sit Remove need for cane crutch or walker Use stairs normally step by step Ability to sleep through night Maintain social activites,caring for someone,playing with children Use public transportation or drive Maintain psychological well-being Maintain sexual activity Maintain employment
- PEQ (Patient Evaluation Questionnaire) Percent Achievement [6 months, 1 year, 2 years]
The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement. EXPECTATIONS KEY: Participate in recreational activities (dancing,traveling,gardening) Exercise or participate in sports Independently perform household chores/daily routine Easily change position,sit to stand/stand to sit Remove need for cane crutch or walker Use stairs normally step by step Ability to sleep through night Maintain social activites,caring for someone,playing with children Use public transportation or drive Maintain psychological well-being Maintain sexual activity Maintain employment
- Acetabular Insert Wear [5 years]
The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.
- Wrist DXA Scan Analysis [5 years]
DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patient is a candidate for a primary total hip replacement.
-
Patient has primary diagnosis of osteoarthritis (OA).
-
Male and non-pregnant female patients ages 18 to 90.
-
Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
-
Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
-
Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.
Exclusion Criteria:
-
Patient has an active infection within the affected hip joint.
-
Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
-
Patient who is morbidly obese, Body Mass Index (BMI) > 40.
-
Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
-
Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
-
Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
-
Patient is a prisoner.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Newport Orthopaedic Institute | Newport Beach | California | United States | 92660 |
| 2 | Alvarado Ortho Medical Group | San Diego | California | United States | 92120 |
| 3 | Orthopaedic Surgery Associates | Boynton Beach | Florida | United States | 33435 |
| 4 | Coastal Orthopaedics | Bradenton | Florida | United States | 34209 |
| 5 | Mayo Clinic Jacksonville | Jacksonville | Florida | United States | 32224 |
| 6 | Hughston Clinic P.A. | Columbus | Georgia | United States | 31908 |
| 7 | Plymouth Bay Ortho Association | Duxbury | Massachusetts | United States | 02332 |
| 8 | New England Orthopaedic Surgeons | Springfield | Massachusetts | United States | 01107 |
| 9 | Specialty Orthopaedics | Harrison | New York | United States | 10528 |
| 10 | Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 23907 |
| 11 | Northwest Orthopaedic Institute | Tacoma | Washington | United States | 98402 |
Sponsors and Collaborators
- Stryker Orthopaedics
Investigators
- Study Chair: Robert Krushell, MD, Baystate Medical Center
- Principal Investigator: Carlton Savory, MD, Hughston Sports Medicine Center
- Principal Investigator: Robert Zann, MD, Boca Raton Community Hospital
- Principal Investigator: Steven Gausewitz, MD, Hoag Hospital
- Principal Investigator: R. Scott Oliver, MD, Jordan Hospital
- Principal Investigator: Mary O'Connor, MD, Mayo Clinic
- Principal Investigator: Anthony Sanchez, MD, Spartanburg Regional Health Service District, Inc
- Principal Investigator: Mark Visk, MD, Spartanburg Regional Health Service District, Inc
- Principal Investigator: Steven Teeny, MD, St. Clare Hospital
- Principal Investigator: Alan Valadie, MD, Coastal Orthopedics and Sports Medicine
- Principal Investigator: Steven Zelicof, MD, Sound Shore Medical Center of Westchester
- Principal Investigator: James Bates, MD, Alvarado Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957658
Other Study ID Numbers:
- 59
First Posted:
Aug 12, 2009
Last Update Posted:
Aug 14, 2017
Last Verified:
Jul 1, 2016
Keywords provided by Stryker Orthopaedics
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 241 participants/249 hips - 7 censored participants/7 hips = 234 participants/242 hips |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Accolade® TMZF® Hip Stem Study Device. Participants have one or both hips replaced. If both hips were replaced, but only one hip completed the primary endpoint, the participant is counted as completed. |
| Period Title: Overall Study | |
| STARTED | 234 |
| COMPLETED | 169 |
| NOT COMPLETED | 65 |
Baseline Characteristics
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Accolade® TMZF® Hip Stem Study Device |
| Overall Participants | 234 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
68.94
(9.77)
|
| Sex/Gender, Customized (participants) [Number] | |
| Female |
149
63.7%
|
| Male |
80
34.2%
|
| Region of Enrollment (participants) [Number] | |
| United States |
234
100%
|
Outcome Measures
| Title | Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain |
|---|---|
| Description | |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Accolade® TMZF® Hip Stem Study Device |
| Measure Participants | 169 |
| Measure hips | 174 |
| Number [percentage of hips] |
98.85
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Accolade® TMZF® Hip Stem |
|---|---|---|
| Comments | Literature control = 96% with no aseptic loosening, intraop femoral fracture or thigh pain at 2 years | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority margin = 6% | |
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Asymptotic WALD test | |
| Comments | ||
| Title | Percentage (%) of Hip Stems With Aseptic Loosening |
|---|---|
| Description | Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data: 111 hips in 106 participants had a radiographic evaluation at 5 years. |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Subjects who received the Accolade® TMZF® Hip Stem |
| Measure Participants | 106 |
| Measure hips | 111 |
| Number [percentage of hips] |
0
|
| Title | Revision/Removal Rates |
|---|---|
| Description | The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals. |
| Time Frame | 2 and 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data: The revision/removal rate of any total hip replacement component at 2 years is reported for 182 hips/176 participants. The revision/removal rate of any component at 5 years is reported for 141 hips/136 participants. |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Subjects who received the Accolade® TMZF® Hip Stem |
| Measure Participants | 176 |
| Measure hip | 182 |
| Revision/removal rate % at 2 years |
1.65
|
| Revision/removal rate % at 5 years |
2.84
|
| Title | Change in Harris Hip Score (HHS) |
|---|---|
| Description | The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor. |
| Time Frame | Preoperative, 2 and 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data: A total of 195 hips had a preoperative score, 174 had a 2 year score, and 117 had a 5 year score. |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Subjects who received the Accolade® TMZF® Hip Stem |
| Measure Participants | 189 |
| Measure hips | 195 |
| Mean HHS score Preoperative (n=195) |
50.1
(11.99)
|
| Mean HHS score 2 years (n=174) |
89.4
(12.67)
|
| Mean HHS score 5 years (N=117) |
92.2
(12.61)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Accolade® TMZF® Hip Stem |
|---|---|---|
| Comments | Improvement from preop to 2 year and preop to 5 year | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Sign test | |
| Comments | ||
| Title | Change in SF-12 Score |
|---|---|
| Description | The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. |
| Time Frame | Preoperative, 2 and 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data: A total of 217 hips had preoperative scores, 175 had 2 year and 121 had 5 year scores. |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Accolade® TMZF® Hip Stem. |
| Measure Participants | 210 |
| Measure hips | 217 |
| Mean SF12 Physical Preoperative (N=217) |
32.3
(8.3)
|
| mean SF12 Mental Preoperative (N=217) |
49.1
(11.99)
|
| Mean SF12 Physical 2 years (N=175) |
45.6
(11.17)
|
| Mean SF12 Mental 2 years (N=175) |
54.2
(8.41)
|
| Mean SF-12 Physical 5 years (N=121) |
44.8
(10.62)
|
| Mean SF-12 Mental 5 years (N=121) |
53.4
(9.45)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Accolade® TMZF® Hip Stem |
|---|---|---|
| Comments | Compare Pre-op SF-12 Physical Score preop to 2 year and preop to 5 year | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Accolade® TMZF® Hip Stem |
|---|---|---|
| Comments | Change in SF-12 Mental Score preop to 2 years | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Sign test | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Accolade® TMZF® Hip Stem |
|---|---|---|
| Comments | Compare SF-12 Mental Score preop to 5 years | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .0004 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change in Lower Extremity Activity Scale (LEAS) Score |
|---|---|
| Description | The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement. |
| Time Frame | Preoperative, 2 and 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data: A total of 231 hips had a preoperative score, 181 had a 2 year, and 129 had a 5 year score. |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Subjects who received the Accolade® TMZF® Hip Stem |
| Measure Participants | 233 |
| Measure hips | 231 |
| Mean LEAS Preoperative (n=231) |
8.4
(3.32)
|
| Mean LEAS 2 year (N=181) |
10.4
(3.18)
|
| Mean LEAS 5 year (N=129) |
10.2
(3.34)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Accolade® TMZF® Hip Stem |
|---|---|---|
| Comments | Compare LEAS score preop to 2 years and preop to 5 years | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Sign test | |
| Comments | ||
| Title | PEQ (Patient Expectation Questionnaire) Overall Satisfaction |
|---|---|
| Description | The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement. EXPECTATIONS KEY: Participate in recreational activities (dancing,traveling,gardening) Exercise or participate in sports Independently perform household chores/daily routine Easily change position,sit to stand/stand to sit Remove need for cane crutch or walker Use stairs normally step by step Ability to sleep through night Maintain social activites,caring for someone,playing with children Use public transportation or drive Maintain psychological well-being Maintain sexual activity Maintain employment |
| Time Frame | 6 months, 1 year and 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Percentage of participants who were satisfied with the result is reported for each expectation at these intervals. |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Subjects who received the Accolade® TMZF® Hip Stem |
| Measure Participants | 201 |
| Measure hips | 206 |
| Recreation 6 mo (n=97) |
84.5
|
| Recreation 1 yr (n=95) |
88.4
|
| Recreation 2 yr (n=76) |
85.5
|
| Exercise/sports 6 mo (n=79) |
89.9
|
| Exercise/sports 1 yr (n=79) |
89.9
|
| Exercise/sports 2 yr (n=67) |
91
|
| Chores 6 mo (n=71) |
91.5
|
| Chores 1 yr (n=65) |
86.2
|
| Chores 2 yr (n=58) |
96.6
|
| Change position 6 mo (n=57) |
87.7
|
| Change position 1 yr (n=58) |
87.9
|
| Change position 2 yr (n=43) |
90.7
|
| No cane/crutch/walker 6 mo (n=57) |
94.7
|
| No cane/crutch/walker 1 yr (n=53) |
94.3
|
| No cane/crutch/walker 2 yr (n=49) |
93.9
|
| Stairs normally 6 mo (n=52) |
80.8
|
| Stairs normally 1 yr (n=58) |
86.2
|
| Stairs normally 2 yr (n=45) |
91.1
|
| Sleep 6 mo (n=52) |
71.2
|
| Sleep 1 yr (n=49) |
77.6
|
| Sleep 2 yr (n=51) |
84.3
|
| Maintain activities 6 mo (n=44) |
90.9
|
| Maintain activities 1 yr (n=41) |
87.8
|
| Maintain activities 2 yr (n=38) |
94.7
|
| Transportation 6 mo (n=27) |
96.3
|
| Transportation 1 yr (n=29) |
96.6
|
| Transportation 2 yr (n=24) |
95.8
|
| Well-being 6 mo (n=21) |
85.7
|
| Well-being 1 yr (n=20) |
95
|
| Well-being 2 yr (n=15) |
86.7
|
| Sexual activity 6 mo (n=15) |
80
|
| Sexual activity 1 yr (n=13) |
84.6
|
| Sexual activity 2 yr (n=12) |
66.7
|
| Employment 6 mo (n=12) |
83.3
|
| Employment 1 yr (n=11) |
81.8
|
| Employment 2 yr (n=8) |
87.5
|
| Title | PEQ (Patient Evaluation Questionnaire) Percent Achievement |
|---|---|
| Description | The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement. EXPECTATIONS KEY: Participate in recreational activities (dancing,traveling,gardening) Exercise or participate in sports Independently perform household chores/daily routine Easily change position,sit to stand/stand to sit Remove need for cane crutch or walker Use stairs normally step by step Ability to sleep through night Maintain social activites,caring for someone,playing with children Use public transportation or drive Maintain psychological well-being Maintain sexual activity Maintain employment |
| Time Frame | 6 months, 1 year, 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Participants select 3 expectations and assess percent achievement (100%,75%,50%,25%,or 0%) at 6 mos, 1 yr and 2 yrs. |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Subjects who received the Accolade® TMZF® Hip Stem |
| Measure Participants | 201 |
| Measure hips | 206 |
| Recreation 100% 6 mo (n=101) |
42.6
18.2%
|
| Recreation 100% 1 yr (n=97) |
55.7
23.8%
|
| Recreation 100% 2 yr (n=83) |
47.0
20.1%
|
| Recreation 75% 6 mo (n=101) |
33.7
14.4%
|
| Recreation 75% 1 yr (n=97) |
28.9
12.4%
|
| Recreation 75% 2 yr (n=83) |
28.9
12.4%
|
| Recreation 50% 6 mo (n=101) |
9.9
4.2%
|
| Recreation 50% 1 yr (n=97) |
8.2
3.5%
|
| Recreation 50% 2 yr (n=83) |
12.0
5.1%
|
| Recreation 25% 6 mo (n=101) |
11.9
5.1%
|
| Recreation 25% 1 yr (n=97) |
3.1
1.3%
|
| Recreation 25% 2 yr (n=83) |
8.4
3.6%
|
| Recreation 0% 6 mo (n=101) |
2.0
0.9%
|
| Recreation 0% 1 yr (n=97) |
4.1
1.8%
|
| Recreation 0% 2 yr (n=83) |
3.6
1.5%
|
| Exercise/sports 100% 6 mo (n=81) |
43.2
18.5%
|
| Exercise/sports 100% 1 yr (n=82) |
51.2
21.9%
|
| Exercise/sports 100% 2 yr (n=74) |
44.6
19.1%
|
| Exercise/sports 75% 6 mo (n=81) |
37.0
15.8%
|
| Exercise/sports 75% 1 yr (n=82) |
29.3
12.5%
|
| Exercise/sports 75% 2 yr (n=74) |
32.4
13.8%
|
| Exercise/sports 50% 6 mo (n=81) |
9.9
4.2%
|
| Exercise/sports 50% 1 yr (n=82) |
9.8
4.2%
|
| Exercise/sports 50% 2 yr (n=74) |
5.4
2.3%
|
| Exercise/sports 25% 6 mo (n=81) |
4.9
2.1%
|
| Exercise/sports 25% 1 yr (n=82) |
8.5
3.6%
|
| Exercise/sports 25% 2 yr (n=74) |
13.5
5.8%
|
| Exercise/sports 0% 6 mo (n=81) |
4.9
2.1%
|
| Exercise/sports 0% 1 yr (n=82) |
1.2
0.5%
|
| Exercise/sports 0% 2 yr (n=74) |
4.1
1.8%
|
| Chores 100% 6 mo (n=74) |
71.6
30.6%
|
| Chores 100% 1 yr (n=72) |
65.3
27.9%
|
| Chores 100% 2 yr (n=65) |
58.5
25%
|
| Chores 75% 6 mos (n=74) |
14.9
6.4%
|
| Chores 75% 1 yr (n=72) |
19.4
8.3%
|
| Chores 75% 2 yr (n=65) |
27.7
11.8%
|
| Chores 50% 6 mo (n=74) |
6.8
2.9%
|
| Chores 50% 1 yr (n=72) |
5.6
2.4%
|
| Chores 50% 2 yr (n=65) |
7.7
3.3%
|
| Chores 25% 6 mo (n=74) |
6.8
2.9%
|
| Chores 25% 1 yr (n=72) |
6.9
2.9%
|
| Chores 25% 2 yr (n=65) |
6.2
2.6%
|
| Chores 0% 6 mo (n=74) |
0
0%
|
| Chores 0% 1 yr (n=72) |
2.8
1.2%
|
| Chores 0% 2 yr (n=65) |
0
0%
|
| Change position 100% 6 mo (n=63) |
58.7
25.1%
|
| Change position 100% 1 yr (n=61) |
60.7
25.9%
|
| Change position 100% 2 yr (n=49) |
57.1
24.4%
|
| Change position 75% 6 mo (n=63) |
28.6
12.2%
|
| Change position 75% 1 yr (n=61) |
31.1
13.3%
|
| Change position 75% 2 yr (n=49) |
26.5
11.3%
|
| Change position 50% 6 mo (n=63) |
6.3
2.7%
|
| Change position 50% 1 yr (n=61) |
8.2
3.5%
|
| Change position 50% 2 yr (n=49) |
14.3
6.1%
|
| Change position 25% 6 mo (n=63) |
6.3
2.7%
|
| Change position 25% 1 yr (n=61) |
0
0%
|
| Change position 25% 2 yr (n=49) |
2.0
0.9%
|
| Change position 0% 6 mo (n=63) |
0
0%
|
| Change position 0% 1 yr (n=61) |
0
0%
|
| Change position 0% 2 yr (n=49) |
0
0%
|
| No cane/crutch/walker 100% 6 mo (n=58) |
79.3
33.9%
|
| No cane/crutch/walker 100% 1 yr (n=54) |
79.6
34%
|
| No cane/crutch/walker 100% 2 yr (n=53) |
77.4
33.1%
|
| No cane/crutch/walker 75% 6 mo (n=58) |
12.1
5.2%
|
| No cane/crutch/walker 75% 1 yr (n=54) |
7.4
3.2%
|
| No cane/crutch/walker 75% 2 yr (n=53) |
7.5
3.2%
|
| No cane/crutch/walker 50% 6 mo (n=58) |
1.7
0.7%
|
| No cane/crutch/walker 50% 1 yr (n=54) |
7.4
3.2%
|
| No cane/crutch/walker 50% 2 yr (n=53) |
7.5
3.2%
|
| No cane/crutch/walker 25% 6 mo (n=58) |
5.2
2.2%
|
| No cane/crutch/walker 25% 1 yr (n=54) |
5.6
2.4%
|
| No cane/crutch/walker 25% 1 yr (n=53) |
5.7
2.4%
|
| No cane/crutch/walker 0% 6 mo (n=58) |
1.7
0.7%
|
| No cane/crutch/walker 0% 1 yr (n=54) |
0
0%
|
| No cane/crutch/walker 0% 2 yr (n=53) |
1.9
0.8%
|
| Stairs normally 100% 6 mo (n=56) |
51.8
22.1%
|
| Stairs normally 100% 1 yr (n=59) |
62.7
26.8%
|
| Stairs normally 100% 2 yr (n=47) |
55.3
23.6%
|
| Stairs normally 75% 6 mo (n=56) |
25
10.7%
|
| Stairs normally 75% 1 yr (n=59) |
6.8
2.9%
|
| Stairs normally 75% 2 yr (n=47) |
8.5
3.6%
|
| Stairs normally 50% 6 mo (n=56) |
7.1
3%
|
| Stairs normally 50% 1 yr (n=59) |
18.6
7.9%
|
| Stairs normally 50% 2 yr (n=47) |
19.1
8.2%
|
| Stairs normally 25% 6 mo (n=56) |
8.9
3.8%
|
| Stairs normally 25% 1 yr (n=59) |
8.5
3.6%
|
| Stairs normally 25% 2 yr (n=47) |
10.6
4.5%
|
| Stairs normally 0% 6 mo (n=56) |
7.1
3%
|
| Stairs normally 0% 1 yr (n=59) |
3.4
1.5%
|
| Stairs normally 0% 2 yr (n=47) |
6.4
2.7%
|
| Sleep 100% 6 mo (n=55) |
43.6
18.6%
|
| Sleep 100% 1 yr (n=53) |
39.6
16.9%
|
| Sleep 100% 2 yr (n=51) |
51.0
21.8%
|
| Sleep 75% 6 mo (n=55) |
20.0
8.5%
|
| Sleep 75% 1 yr (n=53) |
28.3
12.1%
|
| Sleep 75% 2 yr (n=51) |
17.6
7.5%
|
| Sleep 50% 6 mo (n=55) |
18.2
7.8%
|
| Sleep 50% 1 yr (n=53) |
5.7
2.4%
|
| Sleep 50% 2 yr (n=51) |
17.6
7.5%
|
| Sleep 25% 6 mo (n=55) |
7.3
3.1%
|
| Sleep 25% 1 yr (n=53) |
15.1
6.5%
|
| Sleep 25% 2 yr (n=51) |
7.8
3.3%
|
| Sleep 0% 6 mo (n=55) |
10.9
4.7%
|
| Sleep 0% 1 yr (n=53) |
11.3
4.8%
|
| Sleep 0% 2 yr (n=51) |
5.9
2.5%
|
| Maintain activities 100% 6 mo (n=47) |
61.7
26.4%
|
| Maintain activities 100% 1 yr (n=44) |
65.9
28.2%
|
| Maintain activities 100% 2 yr (n=40) |
62.5
26.7%
|
| Maintain activities 75% 6 mo (n=47) |
19.1
8.2%
|
| Maintain activities 75% 1 yr (n=44) |
18.2
7.8%
|
| Maintain activities 75% 2 yr (n=40) |
17.5
7.5%
|
| Maintain activities 50% 6 mo (n=47) |
12.8
5.5%
|
| Maintain activities 50% 1 yr (n=44) |
0
0%
|
| Maintain activities 50% 2 yr (n=40) |
15.0
6.4%
|
| Maintain activities 25% 6 mo (n=47) |
4.3
1.8%
|
| Maintain activities 25% 1 yr (n=44) |
9.1
3.9%
|
| Maintain activities 25% 2 yr (n=40) |
5.0
2.1%
|
| Maintain activities 0% 6 mo (n=47) |
2.1
0.9%
|
| Maintain activities 0% 1 yr (n=44) |
6.8
2.9%
|
| Maintain activities 0% 2 yr (n=40) |
0
0%
|
| Transportation 100% 6 mo (n=30) |
86.7
37.1%
|
| Transportation 100% 1 yr (n=32) |
90.6
38.7%
|
| Transportation 100% 2 yr (n=27) |
77.8
33.2%
|
| Transportation 75% 6 mo (n=30) |
10.0
4.3%
|
| Transportation 75% 1 yr (n=32) |
6.3
2.7%
|
| Transportation 75% 2 yr (n=27) |
14.8
6.3%
|
| Transportation 50% 6 mo (n=30) |
3.3
1.4%
|
| Transportation 50% 1 yr (n=32) |
0
0%
|
| Transportation 50% 2 yr (n=27) |
0
0%
|
| Transportation 25% 6 mo (n=30) |
0
0%
|
| Transportation 25% 1 yr (n=32) |
0.0
0%
|
| Transportation 25% 2 yr (n=27) |
3.7
1.6%
|
| Transportation 0% 6 mo (n=30) |
0.0
0%
|
| Transportation 0% 1 yr (n=32) |
3.1
1.3%
|
| Transportation 0% 2 yr (n=27) |
3.7
1.6%
|
| Well-being 100% 6 mo (n=22) |
54.5
23.3%
|
| Well-being 100% 1 yr (n=24) |
58.3
24.9%
|
| Well-being 100% 2 yr (n=17) |
47.1
20.1%
|
| Well-being 75% 6 mo (n=22) |
31.8
13.6%
|
| Well-being 75% 1 yr (n=24) |
33.3
14.2%
|
| Well-being 75% 2 yr (n=17) |
35.3
15.1%
|
| Well-being 50% 6 mo (n=22) |
9.1
3.9%
|
| Well-being 50% 1 yr (n=24) |
0.0
0%
|
| Well-being 50% 2 yr (n=17) |
11.8
5%
|
| Well-being 25% 6 mo (n=22) |
4.5
1.9%
|
| Well-being 25% 1 yr (n=24) |
8.3
3.5%
|
| Well-being 25% 2 yr (n=17) |
5.9
2.5%
|
| Well-being 0% 6 mo (n=22) |
0.0
0%
|
| Well-being 0% 1 yr (n=24) |
0.0
0%
|
| Well-being 0% 2 yr (n=17) |
0.0
0%
|
| Sexual activity 100% 6 mo (n=15) |
26.7
11.4%
|
| Sexual activity 100% 1 yr (n=14) |
57.1
24.4%
|
| Sexual activity 100% 2 yr (n=14) |
35.7
15.3%
|
| Sexual activity 75% 6 mo (n=15) |
33.3
14.2%
|
| Sexual activity 75% 1 yr (n=14) |
7.1
3%
|
| Sexual activity 75% 2 yr (n=14) |
14.3
6.1%
|
| Sexual activity 50% 6 mo (n=15) |
20.0
8.5%
|
| Sexual activity 50% 1 yr (n=14) |
14.3
6.1%
|
| Sexual activity 50% 2 yr (n=14) |
14.3
6.1%
|
| Sexual activity 25% 6 mo (n=15) |
20.0
8.5%
|
| Sexual activity 25% 1 yr (n=14) |
14.3
6.1%
|
| Sexual activity 25% 2 yr (n=14) |
28.6
12.2%
|
| Sexual activity 0% 6 mo (n=15) |
0.0
0%
|
| Sexual activity 0% 1 yr (n=14) |
7.1
3%
|
| Sexual activity 0% 2 yr (n=14) |
7.1
3%
|
| Employment 100% 6 mo (n=12) |
83.3
35.6%
|
| Employment 100% 1 yr (n=12) |
75.0
32.1%
|
| Employment 100% 2 yr (n=9) |
88.9
38%
|
| Employment 75% 6 mo (n=12) |
0.0
0%
|
| Employment 75% 1 yr (n=12) |
0.0
0%
|
| Employment 75% 2 yr (n=9) |
0.0
0%
|
| Employment 50% 6 mo (n=12) |
0.0
0%
|
| Employment 50% 1 yr (n=12) |
8.3
3.5%
|
| Employment 50% 2 yr (n=9) |
0.0
0%
|
| Employment 25% 6 mo (n=12) |
0.0
0%
|
| Employment 25% 1 yr (n=12) |
8.3
3.5%
|
| Employment 25% 2 yr (n=9) |
0.0
0%
|
| Employment 0% 6 mo (n=12) |
16.7
7.1%
|
| Employment 0% 1 yr (n=12) |
8.3
3.5%
|
| Employment 0% 2 yr (n=9) |
11.1
4.7%
|
| Title | Acetabular Insert Wear |
|---|---|
| Description | The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data: 97 hips were evaluated for wear rate at 5 years. |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Subjects who received the Accolade® TMZF® Hip Stem |
| Measure Participants | 95 |
| Measure hips | 97 |
| Mean (Standard Deviation) [millimeters per year] |
0.0342
(0.0336)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Accolade® TMZF® Hip Stem |
|---|---|---|
| Comments | Compare to historical control (n=94 hips): mean wear 5 years = 0.134 (0.078) | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Wrist DXA Scan Analysis |
|---|---|
| Description | DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data: 107 hips had DXA scan T-scores at 5 years. |
| Arm/Group Title | Accolade® TMZF® Hip Stem |
|---|---|
| Arm/Group Description | Subjects who received the Accolade® TMZF® Hip Stem |
| Measure Participants | 105 |
| Measure hips | 107 |
| Mean (Standard Deviation) [T-score] |
-0.4
(1.05)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Accolade® TMZF® Hip Stem |
|---|---|---|
| Comments | Compare Wrist DXA T-score preop to 5 years | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .0002 |
| Comments | ||
| Method | Sign test | |
| Comments | ||
Adverse Events
| Time Frame | This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants. | |
|---|---|---|
| Adverse Event Reporting Description | Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular & bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs | |
| Arm/Group Title | Accolade TMZF Hip Stem | |
| Arm/Group Description | Participants who received the Accolade TMZF Hip Stem | |
All Cause Mortality |
||
| Accolade TMZF Hip Stem | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Accolade TMZF Hip Stem | ||
| Affected / at Risk (%) | # Events | |
| Total | 65/234 (27.8%) | |
| Blood and lymphatic system disorders | ||
| Non-operative site | 2/234 (0.9%) | 2 |
| Cardiac disorders | ||
| Non-operative site | 10/234 (4.3%) | 13 |
| Endocrine disorders | ||
| Non-operative site | 1/234 (0.4%) | 1 |
| Gastrointestinal disorders | ||
| Non-operative site | 7/234 (3%) | 7 |
| General disorders | ||
| Non-operative site | 4/234 (1.7%) | 4 |
| Infections and infestations | ||
| Non-operative site | 2/234 (0.9%) | 2 |
| Operative site | 2/234 (0.9%) | 2 |
| Injury, poisoning and procedural complications | ||
| Non-operative site | 2/234 (0.9%) | 2 |
| Operative site | 3/234 (1.3%) | 3 |
| Musculoskeletal and connective tissue disorders | ||
| Non-operative site | 8/234 (3.4%) | 8 |
| Operative site | 16/234 (6.8%) | 18 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Non-operative Site | 6/234 (2.6%) | 7 |
| Nervous system disorders | ||
| Non-operative site | 3/234 (1.3%) | 3 |
| Operative site | 1/234 (0.4%) | 1 |
| Psychiatric disorders | ||
| Non-operative site | 1/234 (0.4%) | 1 |
| Renal and urinary disorders | ||
| Non-operative site | 3/234 (1.3%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||
| Non-operative site | 2/234 (0.9%) | 2 |
| Skin and subcutaneous tissue disorders | ||
| Non-operative site | 1/234 (0.4%) | 1 |
| Vascular disorders | ||
| Non-operative site | 6/234 (2.6%) | 8 |
Other (Not Including Serious) Adverse Events |
||
| Accolade TMZF Hip Stem | ||
| Affected / at Risk (%) | # Events | |
| Total | 54/234 (23.1%) | |
| Musculoskeletal and connective tissue disorders | ||
| Operative site Musculoskeletal and Connective tissue disorders | 54/234 (23.1%) | 63 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Each investigator shall have privileges for their own center's results at the completion of the study. These manuscripts and abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.
Results Point of Contact
| Name/Title | Director of Clinical Research |
|---|---|
| Organization | Stryker Orthopaedics |
| Phone | 201-831-5401 |
| Ellen.Axelson@stryker.com |
Responsible Party:
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957658
Other Study ID Numbers:
- 59
First Posted:
Aug 12, 2009
Last Update Posted:
Aug 14, 2017
Last Verified:
Jul 1, 2016