Accolade® TMZF® Hip Stem Outcomes Study

NCT00957658 | Completed Results

• 1 other identifier: 59
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Arthroplasty, Replacement, Hip

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain

  2 years

Secondary Outcomes (9)

• Percentage (%) of Hip Stems With Aseptic Loosening

  5 years

• Revision/Removal Rates

  2 and 5 years

• Change in Harris Hip Score (HHS)

  Preoperative, 2 and 5 years

• Change in SF-12 Score

  Preoperative, 2 and 5 years

• Change in Lower Extremity Activity Scale (LEAS) Score

  Preoperative, 2 and 5 years

Study Arms (1)

Accolade® TMZF® Hip Stem

OTHER

Accolade® TMZF® Hip Stem Study Device

Device: Accolade® TMZF® Hip Stem

Interventions

Accolade® TMZF® Hip Stem DEVICE

Accolade® TMZF® Hip Stem

Accolade® TMZF® Hip Stem

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (11)

Newport Orthopaedic Institute

Newport Beach, California, 92660, United States

Location

Alvarado Ortho Medical Group

San Diego, California, 92120, United States

Location

Orthopaedic Surgery Associates

Boynton Beach, Florida, 33435, United States

Location

Coastal Orthopaedics

Bradenton, Florida, 34209, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Hughston Clinic P.A.

Columbus, Georgia, 31908, United States

Location

Plymouth Bay Ortho Association

Duxbury, Massachusetts, 02332, United States

Location

New England Orthopaedic Surgeons

Springfield, Massachusetts, 01107, United States

Location

Specialty Orthopaedics

Harrison, New York, 10528, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 23907, United States

Location

Northwest Orthopaedic Institute

Tacoma, Washington, 98402, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Stryker Orthopaedics

Ellen.Axelson@stryker.com

201-831-5401

Study Officials

• Robert Krushell, MD

  Baystate Medical Center

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 12, 2009
• Study Start: March 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2014
• Last Updated: August 14, 2017
• Results First Posted: August 15, 2014

Record last verified: 2016-07

Locations

US (11)