Clinical trial NCT00957658: Accolade® TMZF® Hip Stem Outcomes Study
Official title: Accolade® TMZF® Study A Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade® TMZF® Hip Stem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: Osteoarthritis
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain
timeFrame: 2 years
Secondary outcomes:
measure: Percentage (%) of Hip Stems With Aseptic Loosening
timeFrame: 5 years
measure: Revision/Removal Rates
timeFrame: 2 and 5 years
measure: Change in Harris Hip Score (HHS)
timeFrame: Preoperative, 2 and 5 years
measure: Change in SF-12 Score
timeFrame: Preoperative, 2 and 5 years
measure: Change in Lower Extremity Activity Scale (LEAS) Score
timeFrame: Preoperative, 2 and 5 years
measure: PEQ (Patient Expectation Questionnaire) Overall Satisfaction
timeFrame: 6 months, 1 year and 2 years
measure: PEQ (Patient Evaluation Questionnaire) Percent Achievement
timeFrame: 6 months, 1 year, 2 years
measure: Acetabular Insert Wear
timeFrame: 5 years
measure: Wrist DXA Scan Analysis
timeFrame: 5 years
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Newport Orthopaedic Institute
state: California
city: San Diego
country: United States
facility: Alvarado Ortho Medical Group
state: California
city: Boynton Beach
country: United States
facility: Orthopaedic Surgery Associates
state: Florida
city: Bradenton
country: United States
facility: Coastal Orthopaedics
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Columbus
country: United States
facility: Hughston Clinic P.A.
state: Georgia
city: Duxbury
country: United States
facility: Plymouth Bay Ortho Association
state: Massachusetts
city: Springfield
country: United States
facility: New England Orthopaedic Surgeons
state: Massachusetts
city: Harrison
country: United States
facility: Specialty Orthopaedics
state: New York
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Tacoma
country: United States
facility: Northwest Orthopaedic Institute
state: Washington
Study officials:
affiliation: Baystate Medical Center
name: Robert Krushell, MD
role: STUDY_CHAIR
affiliation: Hughston Sports Medicine Center
name: Carlton Savory, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boca Raton Community Hospital
name: Robert Zann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hoag Hospital
name: Steven Gausewitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jordan Hospital
name: R. Scott Oliver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Mary O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spartanburg Regional Health Service District, Inc
name: Anthony Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spartanburg Regional Health Service District, Inc
name: Mark Visk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Clare Hospital
name: Steven Teeny, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Coastal Orthopedics and Sports Medicine
name: Alan Valadie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sound Shore Medical Center of Westchester
name: Steven Zelicof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alvarado Hospital
name: James Bates, MD
role: PRINCIPAL_INVESTIGATOR
References: