Trial Outcomes & Findings for Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant. (NCT NCT02350881)

NCT ID: NCT02350881

Last Updated: 2016-10-31

Results Overview

AOFAS (American Orthopedic Foot and Ankle Society) Hallux-MTP-IP (Hallux-Meta-Tarso-Phalangeal-Inter-Phalangeal) 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. The AOFAS total score is then ranging from 0 to 100 points. A result over 80 points is considered "good", below 20 points as "bad".

• Recruitment status: COMPLETED
• Target enrollment: 70 participants
• Primary outcome timeframe: mean 6.9 years follow-up (range 5.2 - 9.5)
• Results posted on: 2016-10-31

Participant Flow

Recruitment period : from September 2013 to April 2014

Participant milestones

Measure	Overall Cohort one consecutive series of patients were included
Overall Study STARTED	64
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.

Baseline characteristics by cohort

Measure	Overall Cohort n=64 Participants one consecutive series of patients were included
Age, Continuous	59.8 years n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment Italy	64 participants n=5 Participants

PRIMARY outcome

Timeframe: mean 6.9 years follow-up (range 5.2 - 9.5)

Population: number of implants analyzed (70 implants in 64 patients)

AOFAS (American Orthopedic Foot and Ankle Society) Hallux-MTP-IP (Hallux-Meta-Tarso-Phalangeal-Inter-Phalangeal) 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. The AOFAS total score is then ranging from 0 to 100 points. A result over 80 points is considered "good", below 20 points as "bad".

Outcome measures

Measure	Overall Cohort n=70 Number of Implants one consecutive series of patients were included	Moderate Number of patients reporting a moderate pain	Severe Number of patients reporting a severe pain	Greater Number of patients who declared a worsening of pain during walking postoperatively
AOFAS Hallux-MTP-IP Score - Overall	88.9 units on a scale Standard Deviation 9.1	—	—	—

PRIMARY outcome

Timeframe: mean follow-up of 6.9 years (range, 5.2 - 9.5)

Population: Overall cohort

Pain is a sub-score of the AOFAS Hallux-MTP-IP score and is measured on a scale of 40 points - the higher value represents a minimal pain.

Outcome measures

Measure	Overall Cohort n=70 Number of Implants one consecutive series of patients were included	Moderate Number of patients reporting a moderate pain	Severe Number of patients reporting a severe pain	Greater Number of patients who declared a worsening of pain during walking postoperatively
AOFAS Hallux-MTP-IP - PAIN Score	35.4 units on a scale Standard Deviation 5.0	—	—	—

PRIMARY outcome

Timeframe: mean follow-up of 6.9 years (range, 5.2 - 9.5)

Population: Overall cohort

Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits.

Outcome measures

Measure	Overall Cohort n=70 Number of Implants one consecutive series of patients were included	Moderate n=70 Number of Implants Number of patients reporting a moderate pain	Severe n=70 Number of Implants Number of patients reporting a severe pain	Greater Number of patients who declared a worsening of pain during walking postoperatively
Pain at Passive Motion of MTP1 Preoperative	0 Number of Implants	6 Number of Implants	64 Number of Implants	—
Pain at Passive Motion of MTP1 Postoperative	65 Number of Implants	3 Number of Implants	2 Number of Implants	—

PRIMARY outcome

Timeframe: mean follow-up of 6.9 years (range, 5.2 - 9.5)

Population: Overall cohort

Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits.

Outcome measures

Measure	Overall Cohort n=70 Number of Implants one consecutive series of patients were included	Moderate n=70 Number of Implants Number of patients reporting a moderate pain	Severe n=70 Number of Implants Number of patients reporting a severe pain	Greater Number of patients who declared a worsening of pain during walking postoperatively
Pain at Pressure of MTP1 Preperative	0 Number of Implants	16 Number of Implants	54 Number of Implants	—
Pain at Pressure of MTP1 Postoperative	61 Number of Implants	8 Number of Implants	1 Number of Implants	—

PRIMARY outcome

Timeframe: mean follow-up of 6.9 years (range, 5.2 - 9.5)

Population: Overall cohort

Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : "improved", "same", "worsened".

Outcome measures

Measure	Overall Cohort n=70 Number of Implants one consecutive series of patients were included	Moderate n=70 Number of Implants Number of patients reporting a moderate pain	Severe n=70 Number of Implants Number of patients reporting a severe pain	Greater Number of patients who declared a worsening of pain during walking postoperatively
Walking Perimeter	59 Number of Implants	11 Number of Implants	0 Number of Implants	—

PRIMARY outcome

Timeframe: mean follow-up of 6.9 years (range, 5.2 - 9.5)

Population: Overall cohort

Subjective evaluation by patients about pain during walking, postoperatively versus preoperatively. Patients had to choose among 4 variables : "disappeared", "less", same", "greater".

Outcome measures

Measure	Overall Cohort n=70 Number of Implants one consecutive series of patients were included	Moderate n=70 Number of Implants Number of patients reporting a moderate pain	Severe n=70 Number of Implants Number of patients reporting a severe pain	Greater n=70 Number of Implants Number of patients who declared a worsening of pain during walking postoperatively
Pain During Walking	55 Number of Implants	15 Number of Implants	0 Number of Implants	0 Number of Implants

PRIMARY outcome

Timeframe: mean follow-up of 6.9 years (range, 5.2 - 9.5)

Population: Overall cohort

Subjective evaluation of patients about ther pain at rest, postoperatively versus preoperatively. Patients had to choose among 4 variables : "disappeared", "less", "same, "greater".

Outcome measures

Measure	Overall Cohort n=70 Number of Implants one consecutive series of patients were included	Moderate n=70 Number of Implants Number of patients reporting a moderate pain	Severe n=70 Number of Implants Number of patients reporting a severe pain	Greater n=70 Number of Implants Number of patients who declared a worsening of pain during walking postoperatively
Pain at Rest	61 Number of Implants	9 Number of Implants	0 Number of Implants	0 Number of Implants

SECONDARY outcome

Timeframe: mean 6.9 years (range, 5.5 - 9.5)

Population: Overall cohort

Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays.

Outcome measures

Measure	Overall Cohort n=70 Number of Implants one consecutive series of patients were included	Moderate n=70 Number of Implants Number of patients reporting a moderate pain	Severe Number of patients reporting a severe pain	Greater Number of patients who declared a worsening of pain during walking postoperatively
Osteolysis	81.4 percentage of implants	18.6 percentage of implants	—	—

SECONDARY outcome

Timeframe: mean 6.9 years (range, 5.5 - 9.5)

Population: Overall cohort

Bone resorption evaluation was described as : absent or present. Radiological evaluations were performed from available frontal and lateral view X-rays.

Outcome measures

Measure	Overall Cohort n=70 Number of Implants one consecutive series of patients were included	Moderate n=70 Number of Implants Number of patients reporting a moderate pain	Severe Number of patients reporting a severe pain	Greater Number of patients who declared a worsening of pain during walking postoperatively
Bone Resorption	64.3 percentage of implants	35.7 percentage of implants	—	—

SECONDARY outcome

Timeframe: mean follow-up of 6.9 years (range, 5.2 - 9.5)

Population: Overall cohort

The survival of the implant is evaluated according to the number of implant revisions or of reoperations, whatever the reason.

Outcome measures

Measure	Overall Cohort n=70 Number of Implants one consecutive series of patients were included	Moderate n=70 Number of Implants Number of patients reporting a moderate pain	Severe Number of patients reporting a severe pain	Greater Number of patients who declared a worsening of pain during walking postoperatively
Survival of the Implant.	100 percentage of implants	0 percentage of implants	—	—

Adverse Events

Overall Cohort

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Overall Cohort n=64 participants at risk one consecutive series of patients were included
Infections and infestations superficial skin infection around the wound	1.6% 1/64 • Number of events 1 • Adverse events were collected throughout the longest study follow-up, i.e. 144 months.

Additional Information

Dr Stefano Fieschi

Casa di Cura VIlla Berica

Email: stefanofieschi@gmail.com

Results disclosure agreements

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