Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06096168

Acronym

2022-10

Enrollment

Registered

2023-10-23

Start date

2023-04-13

Completion date

2024-10-29

Last updated

2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthropathy

Keywords

Total Hip Prosthesis Revision

Brief summary

This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included. This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient over 18 years old at the time of surgery, * Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2016 and 31/12/2018, * Affiliated to French health insurance system

Exclusion criteria

* Patient who has not expressed consent for data collection and participation in the study, * Patient unable to understand the surgeon's instructions or to perform postoperative follow-up. * Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem * Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication

Design outcomes

Primary

Measure	Time frame	Description
Survival Rate at Mid Term Follow-up	Between 4 to 7 years after surgery	Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation.

Secondary

Measure	Time frame	Description
Survival Rates at Mid Term Follow-up (by Component)	At 4/6 years after surgery	Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding each component of the prothesis
Survival Rates at Mid Term Follow-up (by Etiology)	At 4/6 years after surgery	Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding etiology. Percentage of patients with implant in place dispatched following reason for implantation
Adverse Events	From per operative period to 4/6 years after surgery	List type and frequency of complications, investigated by clinical and radiological examination following investigator's usual practice
Oblivion of Prosthesis	At 4/6 years after surgery	Assess the degree of forgetfulness of the prosthesis using FJS-score (Forgotten Joint Score) : FJS stands for Forgotten Joint Score. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
Functional Improvement	At 4/6 years after surgery	Evaluate pain, walking, limping and activities of daily life using Harris Hip Score : The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome)
Patient's Satisfaction	At 4/6 years after surgery	Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied

Countries

France

Participant flow

Participants by arm

Arm	Count
Per Protocol Population All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria	42
Per Protocol Population All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria	42
Total	84

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	30
Overall Study	Revision	2

Baseline characteristics

Characteristic	Per Protocol Population
Age, Continuous	80.4 years STANDARD_DEVIATION 8.24
Sex: Female, Male Female	18 Participants
Sex: Female, Male Male	24 Participants
Weight	72.8 kg STANDARD_DEVIATION 19

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	30 / 42
other Total, other adverse events	1 / 42
serious Total, serious adverse events	4 / 42

Outcome results

Primary

Survival Rate at Mid Term Follow-up

Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation.

Time frame: Between 4 to 7 years after surgery

Arm	Measure	Value (NUMBER)
Per Protocol Population	Survival Rate at Mid Term Follow-up	90.1 percentage of implant survival

Secondary

Adverse Events

List type and frequency of complications, investigated by clinical and radiological examination following investigator's usual practice

Time frame: From per operative period to 4/6 years after surgery

Arm	Measure	Group	Value (NUMBER)
Per Protocol Population	Adverse Events	Sepsis	1 participants
Per Protocol Population	Adverse Events	Greater trochanter fracture	1 participants
Per Protocol Population	Adverse Events	Posterior dislocation - vicious attitude of the hip	1 participants
Per Protocol Population	Adverse Events	Femoral fracture	1 participants
Per Protocol Population	Adverse Events	Fracture with greater trochanter displacement	1 participants

Secondary

Functional Improvement

Evaluate pain, walking, limping and activities of daily life using Harris Hip Score : The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome)