Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study

NCT03343171 | Active Not Recruiting

• 1 other identifier: 09-H02
• Study Type: observational
• Target: 203
• Locations: 3 countries
• Sites: 6

Brief Summary

The primary objective of this study is to obtain implant survivorship and clinical outcome data for the commercially available Zimmer® Continuum™ Ceramic-on-Ceramic Bearing System when used in primary hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and efficacy of the Continuum Ceramic-on-Ceramic Bearing System.

Conditions

Osteoarthritis; Avascular Necrosis; Inflammatory Arthritis; Post-traumatic Arthritis

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Safety will be evaluated by adverse events reporting.

  Safety will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE)

  10 years

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients, suffering from severe hip pain and disability requiring total hip arthroplasty, who meet the inclusion/exclusion criteria and who receives the Continuum™ Ceramic Bearing System.

You may qualify if:

• Patient is 21 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 vascular (large and small vessel disease) insufficiency.
• The patient has a chronic renal impairment or failure.
• The patient has had previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the joint to be operated
• The patient has a neurologic condition in the ipsolateral 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 informed 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 undergone a total hip replacement, endoprosthesis, or surface arthroplasty of the contralateral (opposite side) hip within the past 6 months regardless of whether the previous hip was enrolled in this clinical study.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

HYKS-instituutti Oy

Helsinki, FI-00029 HUS, Finland

Location

Dipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Università di Pisa

Pisa, 56124, Italy

Location

Policlinico Tor Vergata

Rome, Italy

Location

Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

Nuffield Department of Orthopaedics, University of Oxford

Oxford, OX3 7LD, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis

Condition Hierarchy (Ancestors)

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

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: September 15, 2010
• Primary Completion: February 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

FI (1); IT (2); GB (3)