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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Zimmer, Inc.
Information provided by (Responsible Party):
Zimmer, Inc. Identifier:
First received: February 25, 2011
Last updated: March 30, 2016
Last verified: March 2016
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
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

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 identifier: NCT01307384

Contact: Tamiko MaGee, MS, CCRP 574-372-4389
Contact: Kara Mezger

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   
Principal Investigator: Alexander P Sah, MD         
United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: Corey Henderson    303-602-3800   
Principal Investigator: Eric Mark Hammerberg, MD         
Sponsors and Collaborators
Zimmer, Inc.
  More Information

Responsible Party: Zimmer, Inc. Identifier: NCT01307384     History of Changes
Other Study ID Numbers: CMU2010-02H 
Study First Received: February 25, 2011
Last Updated: March 30, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes processed this record on December 05, 2016