Accolade® TMZF® Hip Stem Outcomes Study

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957658
• Other study ID #: 59
• Status: Completed
• Phase: N/A
• First received: August 10, 2009
• Last updated: November 19, 2015
• Start date: March 2006
• Est. completion date: May 2014

Study information

• Verified date: November 2015
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: May 2014
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem

Locations

Country	Name	City	State
United States	Orthopaedic Surgery Associates	Boynton Beach	Florida
United States	Coastal Orthopaedics	Bradenton	Florida
United States	Hughston Clinic P.A.	Columbus	Georgia
United States	Plymouth Bay Ortho Association	Duxbury	Massachusetts
United States	Specialty Orthopaedics	Harrison	New York
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Newport Orthopaedic Institute	Newport Beach	California
United States	Alvarado Ortho Medical Group	San Diego	California
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	New England Orthopaedic Surgeons	Springfield	Massachusetts
United States	Northwest Orthopaedic Institute	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain		2 years	Yes
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.	5 years	Yes
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.	2 and 5 years	Yes
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.	Preoperative, 2 and 5 years	No
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.	Preoperative, 2 and 5 years	No
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.	Preoperative, 2 and 5 years	No
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	6 months, 1 year and 2 years	No
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	6 months, 1 year, 2 years	No
Secondary	Acetabular Insert Wear	The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.	5 years	Yes
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.	5 years	No