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The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accolade® TMZF® Hip Stem | Other | Accolade® TMZF® Hip Stem Study Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accolade® TMZF® Hip Stem | Device | Accolade® TMZF® Hip Stem |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of Hip Stems With Aseptic Loosening | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Krushell, MD | Baystate Medical Center | Study Chair |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Orthopaedic Institute | Newport Beach | California | 92660 | United States | ||
| Alvarado Ortho Medical Group |
241 participants/249 hips - 7 censored participants/7 hips = 234 participants/242 hips
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| ID | Title | Description |
|---|---|---|
| FG000 | Accolade® TMZF® Hip Stem | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who were censored protocol violations or who were enrolled but did not have surgery or age data was not available, are not included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Accolade® TMZF® Hip Stem | Accolade® TMZF® Hip Stem Study Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain | Posted | Number | percentage of hips | 2 years | hips | hips |
|
|
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.
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Accolade TMZF Hip Stem | Participants who received the Accolade TMZF Hip Stem |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative site | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative site Musculoskeletal and Connective tissue disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Stryker Orthopaedics | 201-831-5401 | Ellen.Axelson@stryker.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 5 years |
| Revision/Removal Rates | 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. | 2 and 5 years |
| Change in Harris Hip Score (HHS) | 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. | Preoperative, 2 and 5 years |
| Change in SF-12 Score | 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. | Preoperative, 2 and 5 years |
| Change in Lower Extremity Activity Scale (LEAS) Score | 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. | Preoperative, 2 and 5 years |
| PEQ (Patient Expectation Questionnaire) Overall Satisfaction | 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 | 6 months, 1 year and 2 years |
| PEQ (Patient Evaluation Questionnaire) Percent Achievement | 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 | 6 months, 1 year, 2 years |
| Acetabular Insert Wear | The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years. | 5 years |
| Wrist DXA Scan Analysis | 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. | 5 years |
| Coastal Orthopedics and Sports Medicine |
| Principal Investigator |
| Steven Zelicof, MD | Sound Shore Medical Center of Westchester | Principal Investigator |
| James Bates, MD | Alvarado Hospital | Principal Investigator |
| San Diego |
| California |
| 92120 |
| United States |
| Orthopaedic Surgery Associates | Boynton Beach | Florida | 33435 | United States |
| Coastal Orthopaedics | Bradenton | Florida | 34209 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Hughston Clinic P.A. | Columbus | Georgia | 31908 | United States |
| Plymouth Bay Ortho Association | Duxbury | Massachusetts | 02332 | United States |
| New England Orthopaedic Surgeons | Springfield | Massachusetts | 01107 | United States |
| Specialty Orthopaedics | Harrison | New York | 10528 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 23907 | United States |
| Northwest Orthopaedic Institute | Tacoma | Washington | 98402 | United States |
| Revision |
|
| Incomplete 2 yr data |
|
| Site termination |
|
| unwilling/unable to return |
|
| surgery cancelled |
|
| Protocol Violation |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Gender is based on 229 participants as there were 5 participants missing gender data. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| hips |
|
|
|
| Secondary | Percentage (%) of Hip Stems With Aseptic Loosening | 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. | Participants with available data: 111 hips in 106 participants had a radiographic evaluation at 5 years. | Posted | Number | percentage of hips | 5 years | hips | hips |
|
|
|
| Secondary | Revision/Removal Rates | 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. | 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. | Posted | Number | percentage of hips/any component revised | 2 and 5 years | hip | hip |
|
|
|
| Secondary | Change in Harris Hip Score (HHS) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Preoperative, 2 and 5 years | hips | hips |
|
|
|
|
| Secondary | Change in SF-12 Score | 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. | Participants with available data: A total of 217 hips had preoperative scores, 175 had 2 year and 121 had 5 year scores. | Posted | Mean | Standard Deviation | units on a scale | Preoperative, 2 and 5 years | hips | hips |
|
|
|
|
| Secondary | Change in Lower Extremity Activity Scale (LEAS) Score | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Preoperative, 2 and 5 years | hips | hips |
|
|
|
|
| Secondary | PEQ (Patient Expectation Questionnaire) Overall Satisfaction | 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 | 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. | Posted | Number | percentage of particpants | 6 months, 1 year and 2 years | hips | hips |
|
|
|
| Secondary | PEQ (Patient Evaluation Questionnaire) Percent Achievement | 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 | 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. | Posted | Number | percentage of participants | 6 months, 1 year, 2 years | hips | hips |
|
|
|
| Secondary | Acetabular Insert Wear | The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years. | Participants with available data: 97 hips were evaluated for wear rate at 5 years. | Posted | Mean | Standard Deviation | millimeters per year | 5 years | hips | hips |
|
|
|
|
| Secondary | Wrist DXA Scan Analysis | 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. | Participants with available data: 107 hips had DXA scan T-scores at 5 years. | Posted | Mean | Standard Deviation | T-score | 5 years | hips | hips |
|
|
|
|
| 65 |
| 234 |
| 54 |
| 234 |
| Non-operative site | Cardiac disorders | Non-systematic Assessment |
|
| Non-operative site | Endocrine disorders | Non-systematic Assessment |
|
| Non-operative site | Gastrointestinal disorders | Non-systematic Assessment |
|
| Non-operative site | General disorders | Non-systematic Assessment |
|
| Non-operative site | Infections and infestations | Non-systematic Assessment |
|
| Operative site | Infections and infestations | Non-systematic Assessment |
|
| Non-operative site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Operative site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Non-operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-operative Site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Non-operative site | Nervous system disorders | Non-systematic Assessment |
|
| Non-operative site | Renal and urinary disorders | Non-systematic Assessment |
|
| Non-operative site | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Non-operative site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Non-operative site | Vascular disorders | Non-systematic Assessment |
|
| Operative site | Nervous system disorders | Non-systematic Assessment |
|
| Non-operative site | Psychiatric disorders | Non-systematic Assessment |
|
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.
|
|
| Mean SF12 Mental 2 years (N=175) |
|
| Mean SF-12 Physical 5 years (N=121) |
|
| Mean SF-12 Mental 5 years (N=121) |
|
| <.0001 |
| Superiority or Other |
| Compare SF-12 Mental Score preop to 5 years | t-test, 2 sided | .0004 | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Exercise/sports 6 mo (n=79) |
|
| Exercise/sports 1 yr (n=79) |
|
| Exercise/sports 2 yr (n=67) |
|
| Chores 6 mo (n=71) |
|
| Chores 1 yr (n=65) |
|
| Chores 2 yr (n=58) |
|
| Change position 6 mo (n=57) |
|
| Change position 1 yr (n=58) |
|
| Change position 2 yr (n=43) |
|
| No cane/crutch/walker 6 mo (n=57) |
|
| No cane/crutch/walker 1 yr (n=53) |
|
| No cane/crutch/walker 2 yr (n=49) |
|
| Stairs normally 6 mo (n=52) |
|
| Stairs normally 1 yr (n=58) |
|
| Stairs normally 2 yr (n=45) |
|
| Sleep 6 mo (n=52) |
|
| Sleep 1 yr (n=49) |
|
| Sleep 2 yr (n=51) |
|
| Maintain activities 6 mo (n=44) |
|
| Maintain activities 1 yr (n=41) |
|
| Maintain activities 2 yr (n=38) |
|
| Transportation 6 mo (n=27) |
|
| Transportation 1 yr (n=29) |
|
| Transportation 2 yr (n=24) |
|
| Well-being 6 mo (n=21) |
|
| Well-being 1 yr (n=20) |
|
| Well-being 2 yr (n=15) |
|
| Sexual activity 6 mo (n=15) |
|
| Sexual activity 1 yr (n=13) |
|
| Sexual activity 2 yr (n=12) |
|
| Employment 6 mo (n=12) |
|
| Employment 1 yr (n=11) |
|
| Employment 2 yr (n=8) |
|
| Title | Measurements |
|---|---|
|
| Recreation 75% 6 mo (n=101) |
|
| Recreation 75% 1 yr (n=97) |
|
| Recreation 75% 2 yr (n=83) |
|
| Recreation 50% 6 mo (n=101) |
|
| Recreation 50% 1 yr (n=97) |
|
| Recreation 50% 2 yr (n=83) |
|
| Recreation 25% 6 mo (n=101) |
|
| Recreation 25% 1 yr (n=97) |
|
| Recreation 25% 2 yr (n=83) |
|
| Recreation 0% 6 mo (n=101) |
|
| Recreation 0% 1 yr (n=97) |
|
| Recreation 0% 2 yr (n=83) |
|
| Exercise/sports 100% 6 mo (n=81) |
|
| Exercise/sports 100% 1 yr (n=82) |
|
| Exercise/sports 100% 2 yr (n=74) |
|
| Exercise/sports 75% 6 mo (n=81) |
|
| Exercise/sports 75% 1 yr (n=82) |
|
| Exercise/sports 75% 2 yr (n=74) |
|
| Exercise/sports 50% 6 mo (n=81) |
|
| Exercise/sports 50% 1 yr (n=82) |
|
| Exercise/sports 50% 2 yr (n=74) |
|
| Exercise/sports 25% 6 mo (n=81) |
|
| Exercise/sports 25% 1 yr (n=82) |
|
| Exercise/sports 25% 2 yr (n=74) |
|
| Exercise/sports 0% 6 mo (n=81) |
|
| Exercise/sports 0% 1 yr (n=82) |
|
| Exercise/sports 0% 2 yr (n=74) |
|
| Chores 100% 6 mo (n=74) |
|
| Chores 100% 1 yr (n=72) |
|
| Chores 100% 2 yr (n=65) |
|
| Chores 75% 6 mos (n=74) |
|
| Chores 75% 1 yr (n=72) |
|
| Chores 75% 2 yr (n=65) |
|
| Chores 50% 6 mo (n=74) |
|
| Chores 50% 1 yr (n=72) |
|
| Chores 50% 2 yr (n=65) |
|
| Chores 25% 6 mo (n=74) |
|
| Chores 25% 1 yr (n=72) |
|
| Chores 25% 2 yr (n=65) |
|
| Chores 0% 6 mo (n=74) |
|
| Chores 0% 1 yr (n=72) |
|
| Chores 0% 2 yr (n=65) |
|
| Change position 100% 6 mo (n=63) |
|
| Change position 100% 1 yr (n=61) |
|
| Change position 100% 2 yr (n=49) |
|
| Change position 75% 6 mo (n=63) |
|
| Change position 75% 1 yr (n=61) |
|
| Change position 75% 2 yr (n=49) |
|
| Change position 50% 6 mo (n=63) |
|
| Change position 50% 1 yr (n=61) |
|
| Change position 50% 2 yr (n=49) |
|
| Change position 25% 6 mo (n=63) |
|
| Change position 25% 1 yr (n=61) |
|
| Change position 25% 2 yr (n=49) |
|
| Change position 0% 6 mo (n=63) |
|
| Change position 0% 1 yr (n=61) |
|
| Change position 0% 2 yr (n=49) |
|
| No cane/crutch/walker 100% 6 mo (n=58) |
|
| No cane/crutch/walker 100% 1 yr (n=54) |
|
| No cane/crutch/walker 100% 2 yr (n=53) |
|
| No cane/crutch/walker 75% 6 mo (n=58) |
|
| No cane/crutch/walker 75% 1 yr (n=54) |
|
| No cane/crutch/walker 75% 2 yr (n=53) |
|
| No cane/crutch/walker 50% 6 mo (n=58) |
|
| No cane/crutch/walker 50% 1 yr (n=54) |
|
| No cane/crutch/walker 50% 2 yr (n=53) |
|
| No cane/crutch/walker 25% 6 mo (n=58) |
|
| No cane/crutch/walker 25% 1 yr (n=54) |
|
| No cane/crutch/walker 25% 1 yr (n=53) |
|
| No cane/crutch/walker 0% 6 mo (n=58) |
|
| No cane/crutch/walker 0% 1 yr (n=54) |
|
| No cane/crutch/walker 0% 2 yr (n=53) |
|
| Stairs normally 100% 6 mo (n=56) |
|
| Stairs normally 100% 1 yr (n=59) |
|
| Stairs normally 100% 2 yr (n=47) |
|
| Stairs normally 75% 6 mo (n=56) |
|
| Stairs normally 75% 1 yr (n=59) |
|
| Stairs normally 75% 2 yr (n=47) |
|
| Stairs normally 50% 6 mo (n=56) |
|
| Stairs normally 50% 1 yr (n=59) |
|
| Stairs normally 50% 2 yr (n=47) |
|
| Stairs normally 25% 6 mo (n=56) |
|
| Stairs normally 25% 1 yr (n=59) |
|
| Stairs normally 25% 2 yr (n=47) |
|
| Stairs normally 0% 6 mo (n=56) |
|
| Stairs normally 0% 1 yr (n=59) |
|
| Stairs normally 0% 2 yr (n=47) |
|
| Sleep 100% 6 mo (n=55) |
|
| Sleep 100% 1 yr (n=53) |
|
| Sleep 100% 2 yr (n=51) |
|
| Sleep 75% 6 mo (n=55) |
|
| Sleep 75% 1 yr (n=53) |
|
| Sleep 75% 2 yr (n=51) |
|
| Sleep 50% 6 mo (n=55) |
|
| Sleep 50% 1 yr (n=53) |
|
| Sleep 50% 2 yr (n=51) |
|
| Sleep 25% 6 mo (n=55) |
|
| Sleep 25% 1 yr (n=53) |
|
| Sleep 25% 2 yr (n=51) |
|
| Sleep 0% 6 mo (n=55) |
|
| Sleep 0% 1 yr (n=53) |
|
| Sleep 0% 2 yr (n=51) |
|
| Maintain activities 100% 6 mo (n=47) |
|
| Maintain activities 100% 1 yr (n=44) |
|
| Maintain activities 100% 2 yr (n=40) |
|
| Maintain activities 75% 6 mo (n=47) |
|
| Maintain activities 75% 1 yr (n=44) |
|
| Maintain activities 75% 2 yr (n=40) |
|
| Maintain activities 50% 6 mo (n=47) |
|
| Maintain activities 50% 1 yr (n=44) |
|
| Maintain activities 50% 2 yr (n=40) |
|
| Maintain activities 25% 6 mo (n=47) |
|
| Maintain activities 25% 1 yr (n=44) |
|
| Maintain activities 25% 2 yr (n=40) |
|
| Maintain activities 0% 6 mo (n=47) |
|
| Maintain activities 0% 1 yr (n=44) |
|
| Maintain activities 0% 2 yr (n=40) |
|
| Transportation 100% 6 mo (n=30) |
|
| Transportation 100% 1 yr (n=32) |
|
| Transportation 100% 2 yr (n=27) |
|
| Transportation 75% 6 mo (n=30) |
|
| Transportation 75% 1 yr (n=32) |
|
| Transportation 75% 2 yr (n=27) |
|
| Transportation 50% 6 mo (n=30) |
|
| Transportation 50% 1 yr (n=32) |
|
| Transportation 50% 2 yr (n=27) |
|
| Transportation 25% 6 mo (n=30) |
|
| Transportation 25% 1 yr (n=32) |
|
| Transportation 25% 2 yr (n=27) |
|
| Transportation 0% 6 mo (n=30) |
|
| Transportation 0% 1 yr (n=32) |
|
| Transportation 0% 2 yr (n=27) |
|
| Well-being 100% 6 mo (n=22) |
|
| Well-being 100% 1 yr (n=24) |
|
| Well-being 100% 2 yr (n=17) |
|
| Well-being 75% 6 mo (n=22) |
|
| Well-being 75% 1 yr (n=24) |
|
| Well-being 75% 2 yr (n=17) |
|
| Well-being 50% 6 mo (n=22) |
|
| Well-being 50% 1 yr (n=24) |
|
| Well-being 50% 2 yr (n=17) |
|
| Well-being 25% 6 mo (n=22) |
|
| Well-being 25% 1 yr (n=24) |
|
| Well-being 25% 2 yr (n=17) |
|
| Well-being 0% 6 mo (n=22) |
|
| Well-being 0% 1 yr (n=24) |
|
| Well-being 0% 2 yr (n=17) |
|
| Sexual activity 100% 6 mo (n=15) |
|
| Sexual activity 100% 1 yr (n=14) |
|
| Sexual activity 100% 2 yr (n=14) |
|
| Sexual activity 75% 6 mo (n=15) |
|
| Sexual activity 75% 1 yr (n=14) |
|
| Sexual activity 75% 2 yr (n=14) |
|
| Sexual activity 50% 6 mo (n=15) |
|
| Sexual activity 50% 1 yr (n=14) |
|
| Sexual activity 50% 2 yr (n=14) |
|
| Sexual activity 25% 6 mo (n=15) |
|
| Sexual activity 25% 1 yr (n=14) |
|
| Sexual activity 25% 2 yr (n=14) |
|
| Sexual activity 0% 6 mo (n=15) |
|
| Sexual activity 0% 1 yr (n=14) |
|
| Sexual activity 0% 2 yr (n=14) |
|
| Employment 100% 6 mo (n=12) |
|
| Employment 100% 1 yr (n=12) |
|
| Employment 100% 2 yr (n=9) |
|
| Employment 75% 6 mo (n=12) |
|
| Employment 75% 1 yr (n=12) |
|
| Employment 75% 2 yr (n=9) |
|
| Employment 50% 6 mo (n=12) |
|
| Employment 50% 1 yr (n=12) |
|
| Employment 50% 2 yr (n=9) |
|
| Employment 25% 6 mo (n=12) |
|
| Employment 25% 1 yr (n=12) |
|
| Employment 25% 2 yr (n=9) |
|
| Employment 0% 6 mo (n=12) |
|
| Employment 0% 1 yr (n=12) |
|
| Employment 0% 2 yr (n=9) |
|