Clinical trial NCT05015101: Evaluation of the Clinical and Radiological Outcome of Uncemented Femoral Stems According to Their Proximal Coating
Official title: Evaluation of the Clinical and Radiological Outcome of Uncemented Femoral Stems According to Their Proximal Coating.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had a total hip replacement for at least five years.

Brief summary: Evaluation of the clinical and radiological outcome of uncemented femoral stems according to their proximal coating.

Retrospective study

Detailed description: On a large population of patients having undergone total hip arthroplasty, divided into two cohorts constituted according to the type of femoral stem implanted (with or without proximal coating by MectaGrip):

Primary objective: To compare between the two groups the radiological osseointegration of the stems five years after arthroplasty.

Secondary objectives: To compare between the groups

* The functional outcome of the arthroplasty
* The frequency of radiological abnormalities (stress shielding, osteolysis, periprosthetic fractures or cracks, periprosthetic ossifications)
* Frequency of complications

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older, having been informed of the research
* A patient with at least five years of uncemented total hip replacement implanted as a first-line procedure
* A patient who has been regularly monitored since surgery and for whom all clinical and radiological data are available at the five-year follow-up visit

Exclusion Criteria:

* Patient operated for revision
* History of femoral fracture (pre or per operative)
* Chronic treatment likely to affect calcium metabolism and ossification
* Patient under legal protection, guardianship or curatorship
* A patient who has indicated his or her opposition to the use of his or her medical data (by completing and returning the non-opposition form that will be sent to him or her).

Primary outcomes:
measure: Engh and Massin Score
timeFrame: 5 years
Secondary outcomes:
measure: Stability of the femoral stem: axial migration (sinking)
timeFrame: 5 years
measure: Stability of the femoral stem: frontal migration (varisation)
timeFrame: 5 years
measure: Gruen's zones assessment
timeFrame: 5 years
measure: Periprosthetic ossifications (Brooker classification)
timeFrame: 5 years
measure: Periprosthetic fractures (Vancouver classification)
timeFrame: 5 years
measure: Harris Hip Score (HHS)
timeFrame: 5 years
measure: Oxford hip score
timeFrame: 5 years
measure: Forgotten Joint Score
timeFrame: 5 years
measure: Life span of prostheses
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique du Sport
Study officials:
affiliation: Clinique du sport
name: Frédéric LAUDE, MD PD
role: PRINCIPAL_INVESTIGATOR
References: