Accolade® TMZF® Hip Stem Outcomes Study

• ClinicalTrials.gov Identifier: NCT00957658
• Recruitment Status: Completed
• First Posted: August 12, 2009
• Results First Posted: August 15, 2014
• Last Update Posted: August 14, 2017
• Sponsor: Stryker Orthopaedics
• Information provided by (Responsible Party): Stryker Orthopaedics

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
Arthroplasty, Replacement, Hip	Device: Accolade® TMZF® Hip Stem	Not Applicable

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 (Clinical Trial)
• 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: March 2006
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
Accolade® TMZF® Hip Stem; Accolade® TMZF® Hip Stem Study Device	Device: Accolade® TMZF® Hip Stem; Accolade® TMZF® Hip Stem

Outcome Measures

Primary Outcome Measures :

1. Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain [ Time Frame: 2 years ]

Secondary Outcome Measures :

1. Percentage (%) of Hip Stems With Aseptic Loosening [ Time Frame: 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.
2. Revision/Removal Rates [ Time Frame: 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.
3. Change in Harris Hip Score (HHS) [ Time Frame: 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.
4. Change in SF-12 Score [ Time Frame: 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.
5. Change in Lower Extremity Activity Scale (LEAS) Score [ Time Frame: 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.
6. PEQ (Patient Expectation Questionnaire) Overall Satisfaction [ Time Frame: 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

7. PEQ (Patient Evaluation Questionnaire) Percent Achievement [ Time Frame: 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

8. Acetabular Insert Wear [ Time Frame: 5 years ]
   The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.
9. Wrist DXA Scan Analysis [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

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

Coastal Orthopaedics

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

Specialty Orthopaedics

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

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

More Information

• Responsible Party: Stryker Orthopaedics
• ClinicalTrials.gov Identifier: NCT00957658
• Other Study ID Numbers: 59
• First Posted: August 12, 2009
• Results First Posted: August 15, 2014
• Last Update Posted: August 14, 2017
• Last Verified: July 2016

Keywords provided by Stryker Orthopaedics:

Osteoarthritis