Clinical trial NCT01307384: Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study
Official title: Prospective Post Market Clinical Follow-Up Study of the Continuum Metal on Polyethylene Acetabular System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Avascular Necrosis
Osteoarthritis
Inflammatory Arthritis
Post-traumatic Arthritis
Rheumatoid Arthritis
Keywords: Total Hip Arthroplasty
Total Hip Replacement (THR)
Primary Hip Arthroplasty
THA
THR
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2011-03-02
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survivorship
timeFrame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
measure: Safety / Adverse Events
timeFrame: Surgery, 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Secondary outcomes:
measure: Pain and Function / HHS
timeFrame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
measure: Pain and Function / OHS
timeFrame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
measure: Health Status / SF-12
timeFrame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
measure: Health Status / Radiographic Parameters
timeFrame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Other outcomes:
measure: Metal Ion / Cobalt
timeFrame: Pre-operatively and at 6 months, 1 year, 2 year and 5 years
measure: Metal Ion / Chromium
timeFrame: Pre-operatively and at 6 months, 1 year, 2 year and 5 years
measure: Metal Ion / Titanium
timeFrame: Pre-operatively and at 6 months, 1 year, 2 year and 5 years
measure: Renal Function / BUN
timeFrame: Pre-operatively and at 6 months, 1 year, 2 year and 5 years
measure: Renal Function / Creatinine
timeFrame: Pre-operatively and at 6 months, 1 year, 2 year and 5 years
measure: Renal Function / GFR
timeFrame: Pre-operatively and at 6 months, 1 year, 2 year and 5 years
Locations:
city: Fremont
country: United States
facility: Sah Orthopaedic Associates
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: