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Clinical Trials in Italy / NCT03343171
Active, not recruiting Observational

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

NCT03343171 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2010-09-15
Last updated
2025-01-31

Condition(s) studied

OsteoarthritisAvascular NecrosisInflammatory ArthritisPost-traumatic Arthritis

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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. 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 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. * 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 had previous girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated. * 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 sensitivity or allergic reaction to one or more of the implanted materials. * The patient is Grade III obese with a Body Mass Index (BMI) \> 35. * The patient has osteoradionecrosis in the affected hip joint

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
HYKS-instituutti Oy Helsinki Finland
Dipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Università di Pisa Pisa Italy
Policlinico Tor Vergata Rome Italy
Glasgow Royal Infirmary Glasgow United Kingdom
Nuffield Department of Orthopaedics, University of Oxford Oxford United Kingdom
Southampton General Hospital Southampton United Kingdom

More Zimmer Biomet trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03343171 on ClinicalTrials.gov ↗ ← All trials in Italy