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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01307384
• Other study ID #: CMU2010-02H
• Status: Active, not recruiting
• Start date: March 29, 2011
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Continuum Metal on Polyethylene Acetabular System
Used in primary hip arthroplasty

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado
United States	Sah Orthopaedic Associates	Fremont	California

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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