Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Zimmer Biomet
Information provided by (Responsible Party):
Zimmer Biomet Identifier:
First received: February 25, 2011
Last updated: January 13, 2017
Last verified: January 2017
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 Biomet:

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 ]

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 ]

Biospecimen Retention:   Samples Without DNA
Blood drawn for metal ion testing

Estimated Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: March 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)
Sexes Eligible for Study:   All
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: Wendy J Hatcher 574-371-9855
Contact: Kara Mezger

United States, California
Dearborn-Sah Institute for Joint Restoration Active, not recruiting
Fremont, California, United States, 94536
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 Biomet
  More Information

Responsible Party: Zimmer Biomet Identifier: NCT01307384     History of Changes
Other Study ID Numbers: CMU2010-02H
Study First Received: February 25, 2011
Last Updated: January 13, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Zimmer Biomet:
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 May 22, 2017