Trial Outcomes & Findings for Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems (NCT NCT06096168)

NCT ID: NCT06096168

Last Updated: 2025-06-25

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 42 participants
• Primary outcome timeframe: Between 4 to 7 years after surgery
• Results posted on: 2025-06-25

Participant Flow

Unit of analysis: 42

Participant milestones

Measure	Per Protocol Population All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria. All patients are included in the same arm. No randomization, no control arm.
Overall Study STARTED	42 42
Overall Study COMPLETED	10 10
Overall Study NOT COMPLETED	32 32

Reasons for withdrawal

Measure	Per Protocol Population All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria. All patients are included in the same arm. No randomization, no control arm.
Overall Study Death	30
Overall Study Revision	2

Baseline Characteristics

Weight not available for 3 patients (3 hips)

Baseline characteristics by cohort

Measure	Per Protocol Population n=42 number of implants All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria
Age, Continuous	80.4 years STANDARD_DEVIATION 8.24 • n=42 Participants
Sex: Female, Male Female	18 Participants n=42 Participants
Sex: Female, Male Male	24 Participants n=42 Participants
Weight	72.8 kg STANDARD_DEVIATION 19.0 • n=39 Participants • Weight not available for 3 patients (3 hips)

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Per Protocol Population n=42 number of implants All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria
Survival Rate at Mid Term Follow-up	90.1 percentage of implant survival

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Per Protocol Population n=42 hips implanted All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria
Adverse Events Sepsis	1 participants
Adverse Events Greater trochanter fracture	1 participants
Adverse Events Posterior dislocation - vicious attitude of the hip	1 participants
Adverse Events Femoral fracture	1 participants
Adverse Events Fracture with greater trochanter displacement	1 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Per Protocol Population n=7 number of hips All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria
Survival Rates at Mid Term Follow-up (by Component)	100 percentage of implant survival

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Per Protocol Population n=5 hips implanted All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria
Survival Rates at Mid Term Follow-up (by Etiology)	80 percentage of implant

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Per Protocol Population n=10 hips implanted All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria
Patient's Satisfaction Very satisfied	4 number of hips
Patient's Satisfaction Rather satisfied	4 number of hips
Patient's Satisfaction Neither satisfied nor unsatisfied	2 number of hips
Patient's Satisfaction Rather unsatisfied	0 number of hips
Patient's Satisfaction Very unsatisfied	0 number of hips

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Per Protocol Population n=9 hips implanted All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria
Oblivion of Prosthesis	80.4 score on a scale Standard Error 10.15

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Per Protocol Population n=9 hips implanted All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria
Functional Improvement	71.5 score on a scale Standard Deviation 21.45

Adverse Events

Per Protocol Population

Serious events: 4 serious events

Other events: 1 other events

Deaths: 30 deaths

Serious adverse events

Measure	Per Protocol Population n=42 participants at risk All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria
Infections and infestations Sepsis	2.4% 1/42 • Number of events 1 • Until >4-years follow up (maximum duration of 90 months)
Surgical and medical procedures Posterior dislocation	2.4% 1/42 • Number of events 1 • Until >4-years follow up (maximum duration of 90 months)
Surgical and medical procedures Femoral fracture	2.4% 1/42 • Number of events 1 • Until >4-years follow up (maximum duration of 90 months)
Surgical and medical procedures Fracture with greater trochanter displacement	2.4% 1/42 • Number of events 1 • Until >4-years follow up (maximum duration of 90 months)

Other adverse events

Measure	Per Protocol Population n=42 participants at risk All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria
Surgical and medical procedures Greater trochanter fracture	2.4% 1/42 • Number of events 1 • Until >4-years follow up (maximum duration of 90 months)

Additional Information

Sponsor

SERF

Phone: 0472056010

Email: clinical@serf.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place