TerminatedNot Applicable

Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System

Stopped: Stafit Acetabular System not CE marked anymore

166 participantsStarted 2011-04-28

Plain-language summary

This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and females * Patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty. * 18 years minimum * Patients able to participate in a follow-up program based upon physical examination and medical history * Patients who have provided written informed consent by signing the Patient Informed Consent Form. Exclusion Criteria: * Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program * Known pregnancy * Revision hip arthroplasty

What they're measuring

Implant Survival

Timeframe: 3 years postoperatively, due to early study termination

Dislocation Rate

Timeframe: 2 years

Trial details

NCT IDNCT04079114

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-01-24

Results submitted2020-04-15

View on ClinicalTrials.gov More Osteoarthritis, Hip trials