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

Prospective Post Market Clinical Follow-Up Study of the Continuum Metal on Polyethylene Acetabular System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Inflammatory Arthritis; Post-traumatic Arthritis
• Intervention / Treatment: Device: Continuum Metal on Polyethylene Acetabular System

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.

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Sah Orthopaedic Associates
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria

• 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.

Exclusion Criteria:

• 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.
• The patient has known local bone tumors and/or cysts in the operative hip.
• The patient has a Body Mass Index (BMI) > 40.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Continuum Acetabular System; Patients receiving primary hip arthroplasty using the Continuum Metal on Polyethylene Acetabular System	Device: Continuum Metal on Polyethylene Acetabular System; Used in primary hip arthroplasty; Other Names: Total Hip Replacement, Total Hip Arthroplasty, Primary Hip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and Function / HHS	Pain and function will be measured using the Harris Hip Score self assessment.	6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Pain and Function / OHS	Pain and function will be measured using the Oxford Hip Score self assessment.	6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Health Status / SF-12	Health status will be measured using the SF-12 self assessment.	6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Health Status / Radiographic Parameters	X-rays will be evaluated for acetabular cup angle, acetabular cup migration, femoral stem position, femoral stem subsidence and femoral stem shift.	6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metal Ion / Cobalt	Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range.	Pre-operatively and at 6 months, 1 year, 2 year and 5 years
Metal Ion / Chromium	Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range.	Pre-operatively and at 6 months, 1 year, 2 year and 5 years
Metal Ion / Titanium	Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range.	Pre-operatively and at 6 months, 1 year, 2 year and 5 years
Renal Function / BUN	Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range.	Pre-operatively and at 6 months, 1 year, 2 year and 5 years
Renal Function / Creatinine	Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range.	Pre-operatively and at 6 months, 1 year, 2 year and 5 years
Renal Function / GFR	Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range.	Pre-operatively and at 6 months, 1 year, 2 year and 5 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hillary Overholser, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2011
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (Estimated): March 2, 2011

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: THA; THR; Total Hip Arthroplasty; Total Hip Replacement (THR); Primary Hip Arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Necrosis
• Other Study ID Numbers: CMU2010-02H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes