Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Zimmer, Inc.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT01307384
First received: February 25, 2011
Last updated: November 14, 2013
Last verified: July 2013
  Purpose

This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.


Condition Intervention
Avascular Necrosis
Osteoarthritis
Inflammatory Arthritis
Post-traumatic Arthritis
Device: Continuum(R) Metal on Polyethylene Acetabular System

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Post Market Clinical Follow-Up Study of the Continuum Metal on Polyethylene Acetabular System

Resource links provided by NLM:


Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Evaluation of the Harris Hip Score - is there a change between each visit interval? [ Time Frame: 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic Evaluation- is there a change between each visit interval? [ Time Frame: 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood drawn for metal ion testing


Estimated Enrollment: 300
Study Start Date: March 2011
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Continuum Acetabular System
Patients receiving primary hip arthroplasty using the Continuum Metal on Polyethylene Acetabular System
Device: Continuum(R) Metal on Polyethylene Acetabular System
Used in primary hip arthroplasty
Other Name: Total Hip Replacement, Total Hip Arthroplasty, Primary Hip

Detailed Description:

The safety and performance of the Continuum Metal on Polyethylene Acetabular System will be confirmed by the assessment of survival and outcome data. Assessments will include standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility, and survivorship of the Continuum Metal on Polyethylene Acetabular system in primary total hip arthroplasty. Metal ion (cobalt, chromium and titanium) and renal function (BUN, Creatinine and GFR) levels will be analyzed for a subset of the enrolled study subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from surgeons medical practice who are candidates for primary hip arthroplasty

Criteria

Inclusion Criteria:

  • Patient is 18 to 75 years of age, inclusive
  • Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following: Avascular Necrosis (AVN), osteoarthritis, inflammatory arthritis (i.e.rheumatoid arthritis), post-traumatic arthritis
  • Patient has no history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joints(s)

Exclusion Criteria:

  • The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
  • The patient has insufficient bone stock to fix the component.
  • The patient has osteoradionecrosis in the affected hip joint.
  • The patient has a known sensitivity or allergic reaction to one of more of the implanted materials.
  • The patient has known local bone tumors and/or cysts in the operative hip.
  • The patient has a Body Mass Index (BMI) >40.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307384

Contacts
Contact: Pamela Moss, BS, RN, CCRP 574-371-1915 pam.moss@zimmer.com
Contact: Kara Mezger kara.mezger@zimmer.com

Locations
United States, California
Dearborn-Sah Institute for Joint Restoration Not yet recruiting
Fremont, California, United States, 94536
Contact: Alexander P Sah, MD    501-793-6653    sah.alexander@gmail.com   
Principal Investigator: Alexander P Sah, MD         
S.T.A.R. Orthopaedics, Inc Recruiting
La Quinta, California, United States, 92253
Contact: Kavita Sinha, MD    760-625-1650    ksinhamd@starortho.com   
Principal Investigator: Raj Sinha, MD         
United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: Doug Gibula, BS, CCRC    303-602-3800    douglas.gibula@dhha.org   
Principal Investigator: Eric Mark Hammerberg, MD         
Sponsors and Collaborators
Zimmer, Inc.
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT01307384     History of Changes
Other Study ID Numbers: CMU2010-02H
Study First Received: February 25, 2011
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Zimmer, Inc.:
Total hip Arthroplasty
Total Hip Replacement (THR)
Primary Hip Arthroplasty
THA
THR

Additional relevant MeSH terms:
Arthritis
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Bone Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 21, 2014