Continuum™ Metal Bearing System in Total Hip Arthroplasty

Continuum™ Metal Bearing System in Total Hip Arthroplasty- A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and outcome data on the Continuum Metal Bearing System in primary total hip arthroplasty.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Avascular Necrosis; Inflammatory Arthritis; Post-traumatic; Arthrosis; Total Hip Arthroplasty

Detailed Description

The subject of this clinical investigation is the Continuum Metal Bearing THA System in primary total hip arthroplasty. This system consists of a cementless modular Trabecular Metal™ (TM) Continuum Acetabular Shell, a modular Metasul Taper liner, and a modular Metasul femoral head. The characteristics of this THA system may allow for reduction in wear and osteolysis as compared to other approved and marketed THA systems and thus increase the expected implant life.

In total, 3 centers will be involved. This number of clinical sites will permit assessment of the consistency among a multitude of investigators. A total number of 100 subjects will be included in the study. It is anticipated that each clinical site will enroll 10 to 45 eligible study subjects, who have provided written informed consent.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Finland
  • Jämsä, Finland
    • Jokilaakson Terveys Oy
  • Turku, Finland, FI-00029 HUS
    • Hospital District of Southwest Finland
• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Saint Davids Medical Center

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

The study population will be comprised of max. 100 males and females who require primary total hip arthroplasty. Subjects will be enrolled at 3 investigative centers. 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 total hip arthroplasty (THA) based on physical exam and medical history including the following:

  • Avascular necrosis (AVN) Osteoarthritis (OA)
  • Inflammatory arthritis (i.e. Rheumatoid arthritis)
  • Post-traumatic arthritis
• Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s).
• Patient has a Harris Hip Score <70 in the affected hip
• 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 Ethics Committee 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 known local bone tumors and/or cysts in the operative hip.
• The patient has a known allergic reaction to one or more of the implanted material.
• The patient is Grade III obese with a Body Mass Index (BMI) ≥ 40.
• The patient has osteoradionecrosis in the affected hip joint
• Kidney insufficiency (Kidney insufficiency will be determined based on eGFR value.

See Blood Analysis Report CRF for details)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients who received the Continuum Metal on Metal System; Patients requiring total hip arthroplasty, who meet the inclusion/exclusion criteria and received the Continuum Metal on Metal System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint for this study is implant survival at 10 years.	The primary endpoint for this study is implant survival, which is assessed by the number of revisions and calculated using the Kaplan-Meier Survival Estimation	10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2011
• Primary Completion (Actual): October 22, 2022
• Study Completion (Actual): October 22, 2022

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Performance; Total hip arthroplasty; Medical Device; Post Market Surveillance Study
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Necrosis
• Other Study ID Numbers: 09-H03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No