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Clinical Trials in Denmark / NCT02518269
Active, not recruiting Not applicable

A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty

NCT02518269 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2015-05-04
Last updated
2025-11-25

Condition(s) studied

OsteoarthrosisPainArthritis

Investigational drug(s) / intervention(s)

Hip Arthroplasty

Hip Arthroplasty: Hip Arthroplasty comparing 3 different bearings.

Study summary

The study is designed to compare three articulation options in terms of osteolysis, patient satisfaction, clinical and radiographic outcomes (Oxford Hip score (OHS) and Harris Hip score (HHS) and safety.

In addition, the purpose of the study is also to evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Echo BiMetric stem in primary total hip arthroplasty.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: Patient is 18 to 75 years of age, inclusive. * Patients determined to be suitable for uncemented fixation by investigator * Patient is skeletally mature. * Patient qualifies for primary unilateral total hip arthroplasty (THA) based on physical exam and medical history including the following: * Osteoarthritis (OA) * Developmental Dysplasia without subluxation * 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. 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 informed consent, or to comply with the follow-up program. * 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 (ex: Dorr type C) in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. * Estimated cup size smaller than 48 or stem size smaller than 7 * The patient has known local bone tumors in the operative hip.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Aalborg University Hospital Aalborg Denmark
Hvidovre hospital Copenhagen Denmark
Jokilaakson Terveys Oy Jämsä Finland
Turku university hospital Turku Finland
Sahlgrenska University Hospital Gothenburg Sweden

More Zimmer Biomet trials in Denmark

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 NCT02518269 on ClinicalTrials.gov ↗ ← All trials in Denmark