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

NCT01307384 | Active Not Recruiting FDA Device

• 1 other identifier: CMU2010-02H
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Avascular Necrosis; Osteoarthritis; Inflammatory Arthritis; Post-traumatic Arthritis; Rheumatoid Arthritis

Keywords

Total Hip Arthroplasty; Total Hip Replacement (THR); Primary Hip Arthroplasty; THA; THR

Outcome Measures

Primary Outcomes (2)

• Survivorship

  Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

  6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year

• Safety / Adverse Events

  Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.

  Surgery, 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year

Secondary Outcomes (4)

• Pain and Function / HHS

  6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year

• Pain and Function / OHS

  6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year

• Health Status / SF-12

  6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year

• Health Status / Radiographic Parameters

  6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year

Other Outcomes (6)

• Metal Ion / Cobalt

  Pre-operatively and at 6 months, 1 year, 2 year and 5 years

• Metal Ion / Chromium

  Pre-operatively and at 6 months, 1 year, 2 year and 5 years

• Metal Ion / Titanium

  Pre-operatively and at 6 months, 1 year, 2 year and 5 years

Study Arms (1)

Continuum Acetabular System

Patients receiving primary hip arthroplasty using the Continuum Metal on Polyethylene Acetabular System

Device: Continuum Metal on Polyethylene Acetabular System

Interventions

Continuum Metal on Polyethylene Acetabular System DEVICE

Used in primary hip arthroplasty

Also known as: Total Hip Replacement, Total Hip Arthroplasty, Primary Hip

Continuum Acetabular System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from surgeons medical practice who are candidates for primary hip arthroplasty. The study population will be comprised of 300 males and females who require primary total hip arthroplasty. Subjects will be enrolled at up to 7 clinical sites. Subjects must be geographically accessible throughout the study and be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will be offered informed consent, and eligibility will be determined based upon the inclusion/exclusion criteria.

You may qualify if:

• Patient is 18 to 75 years of age, inclusive.
• Patient is skeletally mature.
• Patient qualifies for primary unilateral or bilateral (simultaneous or staged) 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 joint(s).
• Patient has moderate, marked or disabling pain.
• Patient is willing and able to provide written informed consent.
• Patient is willing and able to cooperate in the required post-operative therapy.
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
• Patient has participated in the Informed Consent process and has signed the IRB approved informed consent.

You may not qualify if:

• The patient is:
• A prisoner
• Mentally incompetent or unable to understand what participation in the study entails
• A known alcohol or drug abuser
• Anticipated to be non-compliant
• The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure or complications in postoperative care.
• The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
• The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
• The patient is known to be pregnant.
• The patient is unwilling or unable to give consent or to comply with the follow-up program.
• The patient has received an investigational drug or device within the previous 6 months.
• 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. Insufficient bone stock exists in the presence of metabolic bone disease (i.e., osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock.
• The patient has osteoradionecrosis in the affected hip joint.
• The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Sah Orthopaedic Associates

Fremont, California, 94538, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Osteonecrosis; Osteoarthritis; Arthritis; Arthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 2, 2011
• Study Start: March 29, 2011
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)