Continuum™ Metal Bearing System in Total Hip Arthroplasty

NCT ID: NCT03382652

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-09
• Study Completion Date: 2022-10-22

Brief Summary

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.

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.

Conditions

Avascular Necrosis; Osteoarthritis; Inflammatory Arthritis; Post-traumatic; Arthrosis; Total Hip Arthroplasty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Metal-on-Metal Articulation

Intervention Type: DEVICE

\<Metal-on-Metal Articulation\>: Metasul® Taper Liner and Metasul Femoral Head, \<Acetabular Component\>:Continuum Acetabular Shell, \<Femoral Component\>: Zimmer® M/L Taper Hip Stem

Interventions

Metal-on-Metal Articulation

\<Metal-on-Metal Articulation\>: Metasul® Taper Liner and Metasul Femoral Head, \<Acetabular Component\>:Continuum Acetabular Shell, \<Femoral Component\>: Zimmer® M/L Taper Hip Stem

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Achakri

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Saint Davids Medical Center

Austin, Texas, United States

Jokilaakson terveys oy

Jämsä, , Finland

Hospital District of Southwest Finland

Turku, , Finland

Countries

United States; Finland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

09-H03

Identifier Type: -

Identifier Source: org_study_id