Trial Outcomes & Findings for Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices (NCT NCT05672069)

NCT ID: NCT05672069

Last Updated: 2025-01-13

Results Overview

The information will be collected through AOFAS (American Orthopaedic Foot and Ankle Society) score (\>80 points) at 12 months. This score is assessed using a questionnaire measuring the patient's pain, function and alignment of the foot. This score range from 0 (worst score) to 100 (best score). The score is interpreted as follows : Between 90-100 points : excellent results Between 80-89 points : good results Between 60-79 points : fair results Less than 60 points : poor results This score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points.

Recruitment status

COMPLETED

Target enrollment

124 participants

Primary outcome timeframe

12 months

Results posted on

2025-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Total Cohort The description will be carried out on the whole population really included
Overall Study STARTED	124
Overall Study COMPLETED	121
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Cohort The description will be carried out on the whole population really included
Overall Study Implant removal	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Cohort n=124 Participants The description will be carried out on the whole population really included
Age, Continuous	58.20 years STANDARD_DEVIATION 12.89 • n=5 Participants
Sex: Female, Male Female	99 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race/Ethnicity, Customized French nationality	124 Participants n=5 Participants
Operated foot side Right	65 Number of foot n=5 Participants
Operated foot side Left	72 Number of foot n=5 Participants
Foot position Front of foot	123 Number of foot n=5 Participants
Foot position Middle of foot	6 Number of foot n=5 Participants
Foot position Front + Middle of foot	3 Number of foot n=5 Participants
Foot position Back of foot	5 Number of foot n=5 Participants
Weight (kg)	66.72 Kg STANDARD_DEVIATION 14.12 • n=5 Participants
Height of participant (cm)	165.85 cm STANDARD_DEVIATION 7.23 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Total Cohort n=121 Participants The description will be carried out on the whole population really included
Reduction of the Patient's Pain and Restoration of Walking Preoperatively	42.46 points Standard Deviation 15.25
Reduction of the Patient's Pain and Restoration of Walking 12 months	88.44 points Standard Deviation 13.50

SECONDARY outcome

Timeframe: 12 months

Determination of the Kaplan-Meier type survival curve, with any revision as the endpoint whatever the cause. At each inflection point, a revision surgery with removal or revision surgery with removal or change of a component of the implant under consideration All causes of revision are considered. Patients who have died or been lost to follow-up will be included in the analysis.

Outcome measures

Outcome measures
Measure	Total Cohort n=121 Participants The description will be carried out on the whole population really included
Survival Rate	89.3 percentage of implant survivorship

SECONDARY outcome

Timeframe: 12 months

The information will be collected through investigator's question : "on radiographic reading, is the foot bone consolidation satisfactory? : 4 answers are proposed: "total / partial / null / no information".

Outcome measures

Outcome measures
Measure	Total Cohort n=121 Participants The description will be carried out on the whole population really included
Foot Bone Consolidation Total	124 Number of foot
Foot Bone Consolidation Partial	2 Number of foot
Foot Bone Consolidation No consolidation	1 Number of foot
Foot Bone Consolidation Not determined	7 Number of foot

SECONDARY outcome

Timeframe: 12 months

The information will be collected through patient's question : "Considering your expectations, are you satisfied with your operation?" 4 answers are proposed: "I am completely satisfied with the results of my operation results of my operation / My condition has not improved as much as I had hoped, but I but I would be willing to have the same operation for the same result / The operation improved my condition, but I would not be prepared to have the same operation for the same result / My condition is the same or worse than before my operation than before my operation".

Outcome measures

Outcome measures
Measure	Total Cohort n=121 Participants The description will be carried out on the whole population really included
Patient Satisfaction Very satisfied	103 Number of foot
Patient Satisfaction Satisfied	20 Number of foot
Patient Satisfaction Neither satisfied nor unsatisfied	6 Number of foot
Patient Satisfaction Unsatisfied	5 Number of foot

SECONDARY outcome

Timeframe: Peroperative to 12 months

Type and occurrence of adverse events

Outcome measures

Outcome measures
Measure	Total Cohort n=121 Participants The description will be carried out on the whole population really included
Adverse Event Discomfort	8 Number of foot
Adverse Event Pain	3 Number of foot
Adverse Event Pseudoarthrosis	2 Number of foot
Adverse Event Screw protrusion	2 Number of foot
Adverse Event Persistent pain (consolidation with screw protrusion)	1 Number of foot
Adverse Event Post-operative neurological disorders	1 Number of foot
Adverse Event Stiff joint (hallux positioning problem)	1 Number of foot
Adverse Event Loss of correction	1 Number of foot
Adverse Event Scar disunion (poor effectiveness of meching)	1 Number of foot
Adverse Event Locking default between locking screws/plate	1 Number of foot

Adverse Events

Total Cohort

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Total Cohort n=121 participants at risk The adverse event occurred in an implanted foot.
Surgical and medical procedures Persistent pain (consolidation with screw protrusion)	0.83% 1/121 • 12 months
Surgical and medical procedures Arthrodesis pseudarthrosis	0.83% 1/121 • 12 months
Nervous system disorders Post-operative neurological disorders	0.83% 1/121 • 12 months
Surgical and medical procedures Screw protrusion	0.83% 1/121 • 12 months
Surgical and medical procedures Pseudarthrosis	0.83% 1/121 • 12 months

Other adverse events

Other adverse events
Measure	Total Cohort n=121 participants at risk The adverse event occurred in an implanted foot.
Injury, poisoning and procedural complications Persistent / residual pain	2.5% 3/121 • 12 months
Surgical and medical procedures Screws protrusion	0.83% 1/121 • 12 months
Injury, poisoning and procedural complications Discomfort	6.6% 8/121 • 12 months
Surgical and medical procedures Loss of correction	0.83% 1/121 • 12 months
Surgical and medical procedures Scar disunion (poor effectiveness of meching)	0.83% 1/121 • 12 months
Surgical and medical procedures Locking default between locking screws /plate	0.83% 1/121 • 12 months
Surgical and medical procedures Stiff joint (hallux positioning problem)	0.83% 1/121 • 12 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