Trial Outcomes & Findings for Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem (NCT NCT06096155)
NCT ID: NCT06096155
Last Updated: 2026-06-30
Results Overview
Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision
Recruitment status
COMPLETED
Target enrollment
46 participants
Primary outcome timeframe
At 7/10 years after surgery
Results posted on
2026-06-30
Participant Flow
Unit of analysis: number of implants
Participant milestones
| Measure |
Per Protocol Population
The description will be carried out on the whole population really included : patients implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Overall Study
STARTED
|
43 46
|
|
Overall Study
COMPLETED
|
9 9
|
|
Overall Study
NOT COMPLETED
|
34 37
|
Reasons for withdrawal
| Measure |
Per Protocol Population
The description will be carried out on the whole population really included : patients implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Overall Study
Death
|
23
|
|
Overall Study
Lost to Follow-up
|
11
|
Baseline Characteristics
Missing data in patient charts for 25 hips
Baseline characteristics by cohort
| Measure |
Per Protocol Population
n=46 number of implants
Subjects (number of hips) implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Age, Continuous
|
79 years
STANDARD_DEVIATION 7.44 • n=46 number of implants
|
|
Sex: Female, Male
Female
|
27 number of implants
n=46 number of implants
|
|
Sex: Female, Male
Male
|
19 number of implants
n=46 number of implants
|
|
Race/Ethnicity, Customized
French nationality
|
46 number of implants
n=46 number of implants
|
|
Region of Enrollment
France
|
46 number of implant
n=46 number of implants
|
|
Weight
|
74.9 kg
STANDARD_DEVIATION 19.2 • n=21 number of implants • Missing data in patient charts for 25 hips
|
|
Size
|
166 cm
STANDARD_DEVIATION 9.5 • n=26 number of implants • missing data in patient charts for 20 hips
|
|
Hip side
right
|
28 number of implants
n=46 number of implants
|
|
Hip side
left
|
18 number of implants
n=46 number of implants
|
PRIMARY outcome
Timeframe: At 7/10 years after surgeryAssess the survival rate at 7/10 year-follow-up, whatever the cause of revision
Outcome measures
| Measure |
Per Protocol Population
n=46 number of implants
The description will be carried out on the whole population really included : patients implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Survival Rate at Mid/Long Term Follow-up
|
95.7 percentage of implant survival
|
SECONDARY outcome
Timeframe: At 7/10 years after surgeryPopulation: 9 patients (9 implants) of the per protocol population (43 patients / 46 implants) have reached 7/10 years follow-up
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=9 number of implants
The description will be carried out on the whole population really included : patients implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Patient's Satisfaction
Very satisfied
|
7 number of implants
|
|
Patient's Satisfaction
Rather satisfied
|
2 number of implants
|
|
Patient's Satisfaction
Neither satisfied nor unsatisfied
|
0 number of implants
|
|
Patient's Satisfaction
Rather unsatisfied
|
0 number of implants
|
|
Patient's Satisfaction
Very unsatisfied
|
0 number of implants
|
SECONDARY outcome
Timeframe: At 7/10 years after surgeryList type and occurence of adverse events
Outcome measures
| Measure |
Per Protocol Population
n=46 number of implants
The description will be carried out on the whole population really included : patients implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Adverse Events
Arterial disease of lower limb
|
2 number of implants
|
|
Adverse Events
Fibrinolysis catheter removal
|
1 number of implants
|
|
Adverse Events
Femoropopliteal and fibular recanalization
|
1 number of implants
|
|
Adverse Events
Fall leading to hip trauma
|
1 number of implants
|
|
Adverse Events
Fall and impairment of general status
|
1 number of implants
|
|
Adverse Events
Fall leading to subtrochanteric fracture
|
1 number of implants
|
|
Adverse Events
Fall leading to supracondylar fracture
|
1 number of implants
|
|
Adverse Events
Prosthesis loosening
|
1 number of implants
|
|
Adverse Events
Replacement of locking screw
|
2 number of implants
|
|
Adverse Events
Nodular lesion on leg
|
1 number of implants
|
|
Adverse Events
Femoral fracture due to a fall
|
2 number of implants
|
|
Adverse Events
Pain
|
1 number of implants
|
|
Adverse Events
Infection
|
1 number of implants
|
|
Adverse Events
Deep vein thrombosis
|
2 number of implants
|
|
Adverse Events
Fall leading to malleolus fracture
|
1 number of implants
|
|
Adverse Events
Ulcerative wounds on leg
|
2 number of implants
|
|
Adverse Events
Implant revision
|
2 number of implants
|
SECONDARY outcome
Timeframe: At 7/10 years after surgeryPopulation: Only 9 patients (9 implants) of the per protocol population (43 patients / 46 implants) have reached 7/10 years follow-up
Assess the degree of forgetfulness of the prosthesis using FJS-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 number of implants
The description will be carried out on the whole population really included : patients implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Oblivion of Prosthesis
|
87.8 score on a scale
Standard Error 19.68
|
SECONDARY outcome
Timeframe: At 7/10 years after surgeryPopulation: Only 9 patients (9 implants) of the per protocol population (43 patients / 46 implants) have reached 7-10 years follow up
Number of patients experiencing no squeaking
Outcome measures
| Measure |
Per Protocol Population
n=9 number of implants
The description will be carried out on the whole population really included : patients implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Absence of Squeaking
|
9 number of implants
|
SECONDARY outcome
Timeframe: At 7/10 years after surgeryPopulation: Only 9 patients (9 implants) of the per protocol population (43 patients/46 implants) have reached 7-10 years follow-up
The only measure to be considered is "Modified Harris Hip Score" which consists of a 0 to 100 points scale (100 points is the better outcome). The data retrieved from site is only 1 figure ranging from 0 to 100.
Outcome measures
| Measure |
Per Protocol Population
n=9 number of implants
The description will be carried out on the whole population really included : patients implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Functional Improvement
|
80.7 score on a scale
Standard Deviation 19.68
|
Adverse Events
Per Protocol Population
Serious events: 15 serious events
Other events: 8 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Per Protocol Population
n=46 participants at risk
Subjects (number of hips) implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Surgical and medical procedures
femoral fracture due to a fall
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Surgical and medical procedures
Revision
|
4.3%
2/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
General disorders
Pain
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Infections and infestations
Infection
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Vascular disorders
Deep vein thrombosis
|
4.3%
2/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Vascular disorders
Arterial disease of lower limb
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Vascular disorders
Femoropopliteal and fibular recanalization
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Surgical and medical procedures
Fall leading to subtrochanteric fracture
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Surgical and medical procedures
Fall leading to supracondylar fracture
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Surgical and medical procedures
Prosthesis loosening
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Surgical and medical procedures
Replacement of locking screw
|
4.3%
2/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Surgical and medical procedures
Nodular lesion on leg
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
Other adverse events
| Measure |
Per Protocol Population
n=46 participants at risk
Subjects (number of hips) implanted with SAGITTA EVL-R meeting inclusion and exclusion criteria
|
|---|---|
|
Surgical and medical procedures
Fall leading to malleolus fracture
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Skin and subcutaneous tissue disorders
Ulcerative wounds on leg
|
4.3%
2/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Vascular disorders
Arterial disease of lower limb
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Vascular disorders
Fibrinolysis catheter removal
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Surgical and medical procedures
Fall leading to hip trauma
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
General disorders
Fall and impairment of general status
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
|
Surgical and medical procedures
Femoral fracture due to a fall
|
2.2%
1/46 • per protocol : 7 to 10 years post-op +/- 2 years with a maximum delay of 151.6 months
To be clear, the occurence of SAE is calculated as follows : number of event/ number of implants. So please note that the number of Participants at Risk represents the number of units (i.e., implants) that were monitored/assessed for Adverse Events (applicable for "Serious adverse events" and "Other (Not Including Serious) adverse events"), 46 implants. On the contrary, for All-cause mortality, the number of patients has to be considered (43 patients)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place