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
• Intervention / Treatment: Device: Metal-on-Metal Articulation

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 sites were involved. This number of clinical sites permitted assessment of the consistency among a multitude of investigators. A total number of 83 were included in the study.

• Study Type: Observational
• Enrollment (Actual): 83

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	Intervention / Treatment
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	Device: Metal-on-Metal Articulation; : Metasul® Taper Liner and Metasul Femoral Head, :Continuum Acetabular Shell, : Zimmer® M/L Taper Hip Stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival at 10 Years	The primary endpoint for this study is implant survival at 10 years which was assessed by revision either of the Continuum Cup or the Metasul liner. A success rate for the experimental group was calculated using the Kaplan-Meier Survival Estimation.	1, 2, 3, 5, 7, and 10 years postop.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Harris Hip Score (HHS)	The Harris hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care Professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). The total score can vary from a range of 0 - 100. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70.	Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op
The Subject Quality-of-Life (SF-12): Physical and Mental Socres	SF12: The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.	Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op
Radiographic Evaluations	Radiographic evaluation was performed in order to identify potential adverse events. Investigators at each site were responsible for reviewing the radiological images for any abnormal or significant findings and reporting adverse events if applicable. In addition, an independent radiographic reviewer performed assessments of radiographic films in terms of evidence of radiolucencies, osteolysis, subsidence, acetabular cup migration, and change in acetabular cup angle at 6 months, 1 year and 2 year post-operation. Outcomes included numbers of reported findings per anatomical position and time point.	Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op.
Metal Ion Concentration in Blood	Metal ion levels (cobalt, chromium and titanium) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.	Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.
EQ5D	EQ5D: The EQ-5D is a standardized Instrument widely used to measure health status. It is a self reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self care, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state worse than being dead. The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The warst health you can imagine') where the patient reports his/her self-rated health.	Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op
Creatine Concentration and BUN	Renal function (BUN and Creatinine) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.	Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.
Calculated GFR	Renal function (BUN, Creatinine and GFR) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.	Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.

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 (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

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

Drug and device information, study documents

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