Suspended

ExceptionException Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)

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What is being collected

Data Collection

Who is being recruted

Congenital Abnormalities+20

+ Developmental Dysplasia of the Hip

+ Arthritis

From 18 to 100 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2021
See protocol details

Summary

Principal SponsorZimmer Biomet
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2021

Actual date on which the first participant was enrolled.

Six surgeons have prospectively collected clinical data for patients operated consecutively between January 2008 and September 2012. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant. This study is an extension of the surgeons' data collection as an attempt from Zimmer-Biomet to fulfill its post-market surveillance obligations by recovering clinical data retrospectively and prospectively. Study Procedure Flowchart - retrospective data collection: most patients had clinical follow-ups at pre-op, operative, immediate post-op, 3 Months, 1 year, 2, 3, 5, 7 years post-surgery during which their surgeons collected clinical data. This data will therefore only be collected by Zimmer-Biomet after the patients specifically consent to it. Study Procedure Flowchart - prospective data collection: The informed consent signed by the patient for this study also allow Zimmer Biomet to collect the data of the standard clinical follow-up that will be conducted by the investigators at least 10 years post-surgery.

Official TitleException Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)
NCT04349046
Principal SponsorZimmer Biomet
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

332 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Congenital AbnormalitiesDevelopmental Dysplasia of the HipArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesFemoral FracturesFemoral Neck FracturesHip Dislocation, CongenitalHip FracturesImmune System DiseasesJoint DiseasesLeg InjuriesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOsteoarthritisRheumatic DiseasesWounds and InjuriesOsteoarthritis, HipSkin and Connective Tissue DiseasesHip InjuriesFractures, Bone

Criteria

7 exclusion criteria prevent from participating
Local or systemic infections.

Serious muscular, neurological or vascular deficiencies in the limb concerned.

Bone destruction or poor quality bone likely to affect the stability of the implant (Paget's disease, osteoporosis, etc.)

Any concomitant disorder likely to affect the function of the implant.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

Hôpital Princesse Paola

Aye, BelgiumOpen Hôpital Princesse Paola in Google Maps
Suspended

CH Alpes Léman

Contamine-sur-Arve, France
Suspended

CH Annecy Genevois

Épagny, France
Suspended

Hopital Renee Sabran

Hyères, France
Suspended6 Study Centers