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

Active, not recruiting

• Conditions: Inflammatory Arthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Avascular Necrosis; Osteoarthritis
• Interventions: Device: Continuum Metal on Polyethylene Acetabular System

• Registration Number: NCT01307384
• Lead Sponsor: Zimmer Biomet

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.

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 Timeline

• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-02
• Study Start: 2011-03-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Survivorship	6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year	Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Safety / Adverse Events	Surgery, 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year	Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Sah Orthopaedic Associates; 🇺🇸 Fremont, California, United States

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States