Trilogy AB Acetabular Hip System Post Approval Study

NCT00715026 | Terminated Phase 4 Results

• 2 other identifiers: 06-30006-300, Revised 3-1-2010
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

This is a post-approval study with prospective enrollment in the United States and a retrospective enrollment outside the United States to obtain functional, quality of life and radiographic data, which will facilitate assessment of the clinical performance of the Zimmer Trilogy AB Acetabular Hip System.

Conditions

Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Traumatic Arthritis

Keywords

Arthritis; Total Hip; Ceramic; Hip Replacement; Total Hip Arthroplasty (THA); Joint Disease

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score

  The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.

  Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years

Secondary Outcomes (1)

• Continued Assessment of Implant Survivorship and Incidences of Adverse Events.

  At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years

Study Arms (1)

Trilogy AB Acetabular Hip Implant System

OTHER

Post Approval Study of Device.

Device: Trilogy AB Acetabular Hip Implant System

Interventions

Trilogy AB Acetabular Hip Implant System DEVICE

Total hip replacement with ceramic on ceramic treatment surfaces.

Trilogy AB Acetabular Hip Implant System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-obese patients
• The patient is a good candidate for a primary hip arthroplasty using the Zimmer Trilogy AB Acetabular Hip System.
• Patient is willing and able to give informed consent to participate in the follow-up program.
• Patient is suitable for surgery and able to participate in the follow-up program.

You may not qualify if:

• Skeletally immature
• Rheumatoid arthritis
• Osteoradionecrosis
• Infection
• Nerve or muscle disease that may have a negative affect on gait or weight bearing
• Loss of abductor musculature in the affected limb
• Poor bone stock
• Poor skin coverage around the hip joint
• Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray
• Previous total or cemented hemi-arthroplasty of the affected hip
• Previous pinning or plating of the affected hip
• Patients with heavy labor jobs or extreme activity levels
• Patients who participate in sports activities or require deep flexion
• Patients who are obese
• Patients who have other disabilities

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Shrock Orthopedic Research

Fort Lauderdale, Florida, 33136, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Hip Dislocation, Congenital; Arthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

A business decision unrelated to device performance led to the early termination of the study and withdrawal of the study device(s) from the US market. Early termination of the study limits the usefulness of the available data.

Results Point of Contact

• Title: Director, Clinical Affairs
• Organization: Zimmer

erin.osborn@zimmer.com

574-371-8019

Study Officials

• Kevin Schrock, MD

  Schrock Orthopedic Research

  PRINCIPAL INVESTIGATOR

• Gwo-Chin Lee, MD

  University of Pennsylvania/Penn Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 15, 2008
• Study Start: April 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 26, 2014
• Results First Posted: November 26, 2014

Record last verified: 2014-11

Locations

US (2)