Trial Outcomes & Findings for Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples (NCT NCT05523219)

Results Overview

To confirm the performance of varisation staples in conservative surgery of Hallux Valgus, according to the indications covered by the CE Marking (Akin's osteotomy) and according to the surgeon's current practice investigator. The scores range from 0 to 100, The average preoperative score was 50 to 60 points. Post-operatively, a score of 80 points is a good post-operative result, with the patient experiencing no or low levels of residual pain and full or partial recovery of joint function. The AOFAS Score is considered excellent between 90 and 100 points, good between 80 and 89, fair between 60 and 79, and poor below 60 points.

Recruitment status

COMPLETED

Target enrollment

81 participants

Primary outcome timeframe

3 and 12 months

Results posted on

2024-05-01

Participant Flow

Patients implanted with VEOFIX varisation staples between 15/02/2021 and 15/05/2021 in Clinique Victor Hugo.

No SERF assembly

Participant milestones

Participant milestones
Measure	Total Cohort The description will be carried out on the whole population really included
Overall Study STARTED	81
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Cohort The description will be carried out on the whole population really included
Overall Study Wrong inclusion	1
Overall Study Lost to Follow-up	7

Baseline Characteristics

Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Cohort n=80 Participants The description will be carried out on the whole population really included
Age, Continuous	55.3 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized French nationality	80 Participants n=5 Participants
Side : Right, Left Right	51 Participants n=5 Participants
Side : Right, Left Left	29 Participants n=5 Participants
Indication : Hallux Valgus	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 and 12 months

Population: The number of scores is different for each follow-up. In fact, this score is recovered during patient follow-up.

To confirm the performance of varisation staples in conservative surgery of Hallux Valgus, according to the indications covered by the CE Marking (Akin's osteotomy) and according to the surgeon's current practice investigator. The scores range from 0 to 100, The average preoperative score was 50 to 60 points. Post-operatively, a score of 80 points is a good post-operative result, with the patient experiencing no or low levels of residual pain and full or partial recovery of joint function. The AOFAS Score is considered excellent between 90 and 100 points, good between 80 and 89, fair between 60 and 79, and poor below 60 points.

Outcome measures

Outcome measures
Measure	Total Cohort n=80 Participants The description will be carried out on the whole population really included
AOFAS Score Preoperatively	41.2 points Standard Deviation 17.5
AOFAS Score 3 months	77.0 points Standard Deviation 9.1
AOFAS Score 12 months	88.1 points Standard Deviation 9.4

SECONDARY outcome

Timeframe: 3 and 12 months

Population: * 80 patients preoperatively; * 78 patients were available at 3 months follow-up. * 73 patients were available at 12 months follow-up.

The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation

Outcome measures

Outcome measures
Measure	Total Cohort n=80 Participants The description will be carried out on the whole population really included
Patient Satisfaction 3 months · Very satisfied	17 Participants
Patient Satisfaction 3 months · Satisfied	56 Participants
Patient Satisfaction 3 months · Dissatisfied	5 Participants
Patient Satisfaction 3 months · Dissappointed	0 Participants
Patient Satisfaction 12 months · Very satisfied	43 Participants
Patient Satisfaction 12 months · Satisfied	28 Participants
Patient Satisfaction 12 months · Dissatisfied	1 Participants
Patient Satisfaction 12 months · Dissappointed	1 Participants

SECONDARY outcome

Timeframe: 12 months

Number of complications observed throughout the clinical investigation

Outcome measures

Outcome measures
Measure	Total Cohort n=80 Participants The description will be carried out on the whole population really included
Number of Complications Observed During the Clinical Investigation Neurogenic pain after loco-regional anaesthesia	4 events
Number of Complications Observed During the Clinical Investigation Paraesthesia O1	1 events
Number of Complications Observed During the Clinical Investigation Hallux varus	2 events

Adverse Events

Total Cohort

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Total Cohort n=80 participants at risk The description will be carried out on the whole population really included
Nervous system disorders Neurogenic pain after locoregional anaesthesia	5.0% 4/80 • Number of events 4 • 14.9 months
Surgical and medical procedures Paresthesia O1	1.2% 1/80 • Number of events 1 • 14.9 months
Surgical and medical procedures Hallux Varus	2.5% 2/80 • Number of events 2 • 14.9 months

Additional Information

Sponsor

SERF

Phone: +33 4.72.05.60.10

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place