Accolade® TMZF® Hip Stem Outcomes Study

Accolade® TMZF® Study A Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade® TMZF® Hip Stem

The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Accolade® TMZF® Hip Stem

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 Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92660
      • Newport Orthopaedic Institute
    • San Diego, California, United States, 92120
      • Alvarado Ortho Medical Group
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Orthopaedic Surgery Associates
    • Bradenton, Florida, United States, 34209
      • Coastal Orthopaedics
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
  • Georgia
    • Columbus, Georgia, United States, 31908
      • Hughston Clinic P.A.
  • Massachusetts
    • Duxbury, Massachusetts, United States, 02332
      • Plymouth Bay Ortho Association
    • Springfield, Massachusetts, United States, 01107
      • New England Orthopaedic Surgeons
  • New York
    • Harrison, New York, United States, 10528
      • Specialty Orthopaedics
  • South Carolina
    • Spartanburg, South Carolina, United States, 23907
      • Spartanburg Regional Medical Center
  • Washington
    • Tacoma, Washington, United States, 98402
      • Northwest Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is a candidate for a primary total hip replacement.
2. Patient has primary diagnosis of osteoarthritis (OA).
3. Male and non-pregnant female patients ages 18 to 90.
4. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
5. Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
6. Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.

Exclusion Criteria:

1. Patient has an active infection within the affected hip joint.
2. Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
3. Patient who is morbidly obese, Body Mass Index (BMI) > 40.
4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
5. Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
6. Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
7. Patient is a prisoner.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Accolade® TMZF® Hip Stem; Accolade® TMZF® Hip Stem Study Device	Device: Accolade® TMZF® Hip Stem; Accolade® TMZF® Hip Stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain	2 years

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Study Chair: Robert Krushell, MD, Baystate Medical 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: 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 record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: August 10, 2009
• First Submitted That Met QC Criteria: August 11, 2009
• First Posted (ESTIMATE): August 12, 2009

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Osteoarthritis
• Other Study ID Numbers: 59