Trial Outcomes & Findings for Assessment of the Safety and the Performance of the SAGITTA EVL R Stems in Hip Arthroplasties (NCT NCT05153473)

Results Overview

Recruitment status

COMPLETED

Target enrollment

120 participants

Primary outcome timeframe

at 5 years follow-up

Results posted on

2024-11-29

Participant Flow

Unit of analysis: 124

Participant milestones

Participant milestones
Measure	SAGITTA EVL R Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem.
Overall Study STARTED	120 124
Overall Study COMPLETED	71 73
Overall Study NOT COMPLETED	49 51

Reasons for withdrawal

Reasons for withdrawal
Measure	SAGITTA EVL R Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem.
Overall Study Death	46
Overall Study Lost to Follow-up	3

Baseline Characteristics

Sex information were not collected for one subject

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SAGITTA EVL R n=120 Participants Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem.
Age, Continuous	73.6 years STANDARD_DEVIATION 11.6 • n=120 Participants
Sex: Female, Male Female	64 Participants n=119 Participants • Sex information were not collected for one subject
Sex: Female, Male Male	55 Participants n=119 Participants • Sex information were not collected for one subject
Weight	77.5 Kilograms STANDARD_DEVIATION 20.7 • n=120 Participants

PRIMARY outcome

Timeframe: at 5 years follow-up

Population: Patient that have reached the last Follow-up.

Outcome measures

Outcome measures
Measure	SAGITTA EVL R n=73 Stems implanted Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem.
Survival Rate of Stems	94 Percentage of stem unrevised

SECONDARY outcome

Timeframe: at 5 years follow-up

The information will be collected from the patient by answering a Yes/No question at last follow-up. The following result correspond to the number of patients that have been satisfied

Outcome measures

Outcome measures
Measure	SAGITTA EVL R n=71 Participants Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem.
Patient Satisfaction	53 Participants

SECONDARY outcome

Timeframe: at 5 years follow-up

The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation. The patient will estimate the improvement in 3 scales: improved/unchanged/Worsen. The result present number of patient answering improved.

Outcome measures

Outcome measures
Measure	SAGITTA EVL R n=71 Participants Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem.
Functional Improvement	41 Participants

SECONDARY outcome

Timeframe: at 5 years follow-up

The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation. The patient will estimate the pain diminution with 2 options: Yes or No diminution of pain. Result presents the number of patient having pain diminution

Outcome measures

Outcome measures
Measure	SAGITTA EVL R n=71 Participants Patients of this group have received a total hip replacement with a SAGITTA EVL R Stem.
Pain Release	53 Participants

Adverse Events

SAGITTA EVL R

Serious events: 0 serious events

Other events: 0 other events

Deaths: 46 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Louis Etienne GAYET

CHU de Poitiers

Phone: +33(0)5.49.44.44.92

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place