Continuum™ Metal Bearing System in Total Hip Arthroplasty

NCT03382652 | Completed Results FDA Device

• 1 other identifier: 09-H03
• Study Type: observational
• Target: 83
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Keywords

Total hip arthroplasty; Medical Device; Post Market Surveillance Study; Performance; Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The Harris Hip Score (HHS)

  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

  Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op

• Radiographic Evaluations

  Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op.

• Metal Ion Concentration in Blood

  Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.

• EQ5D

  Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op

Study Arms (1)

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

Interventions

Metal-on-Metal Articulation 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

Patients who received the Continuum Metal on Metal System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Saint Davids Medical Center

Austin, Texas, 78705, United States

Location

Jokilaakson terveys oy

Jämsä, Finland

Location

Hospital District of Southwest Finland

Turku, FI-00029 HUS, Finland

Location

MeSH Terms

Conditions

Osteonecrosis; Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Rheumatic Diseases

Limitations and Caveats

The US site was terminated after the 7-year follow up.

Results Point of Contact

• Title: Esther Foo
• Organization: Zimmer Biomet

esther.foo@zimmerbiomet.com

+41787183202

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: February 9, 2011
• Primary Completion: October 22, 2022
• Study Completion: October 22, 2022
• Last Updated: January 3, 2025
• Results First Posted: December 16, 2024

Record last verified: 2024-12

Locations

FI (2); US (1)