Accolade® TMZF® Hip Stem Outcomes Study
The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.
|Study Design:||Intervention Model: Single Group Assignment
Masking: 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|
- Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Percentage (%) of Hip Stems With Aseptic Loosening [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: 2 and 5 years ] [ Designated as safety issue: Yes ]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) [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]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 [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]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 [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]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 Data [ Time Frame: 6 months, 1 year and 2 years ] [ Designated as safety issue: No ]The PEQ (Patient Expectation Questionnaire) is a study sponsor generated outcomes form. It is a one page questionnaire completed by the patient to assess lifestyle recovery post-surgery. Preoperatively, patients 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 patients evaluated the 3 expectations they identified and assessed their percent achievement and overall satisfaction.
- Acetabular Insert Wear [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.
- Wrist DXA Scan Analysis [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2006|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem Study Device
Device: Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957658
|United States, California|
|Newport Orthopaedic Institute|
|Newport Beach, California, United States, 92660|
|Alvarado Ortho Medical Group|
|San Diego, California, United States, 92120|
|United States, Florida|
|Orthopaedic Surgery Associates|
|Boynton Beach, Florida, United States, 33435|
|Bradenton, Florida, United States, 34209|
|Mayo Clinic Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Georgia|
|Hughston Clinic P.A.|
|Columbus, Georgia, United States, 31908|
|United States, Massachusetts|
|Plymouth Bay Ortho Association|
|Duxbury, Massachusetts, United States, 02332|
|New England Orthopaedic Surgeons|
|Springfield, Massachusetts, United States, 01107|
|United States, New York|
|Harrison, New York, United States, 10528|
|United States, South Carolina|
|Spartanburg Regional Medical Center|
|Spartanburg, South Carolina, United States, 23907|
|United States, Washington|
|Northwest Orthopaedic Institute|
|Tacoma, Washington, United States, 98402|
|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|