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

• Sponsor: Stryker Trauma GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02350881
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

Foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants. Allergies to silicone, infections due to silicone and implants breakage used to be common with previous generations of silicone implants. Publications relative to those implants showed that the survival rates after 5 years of follow-up were unsatisfactory.

Since 1998, Tornier has been selling a new generation of silicone implants made of Ultrasil™. The use of this new material in its manufacturing process together with its innovative geometry, make the Primus™ FGT a much more resistant, anatomic and long lasting implant.

The main objective of this study is to evaluate the clinical outcomes of the implantation of Primus™ FGT implant in great toe arthroplasty. The study will capture long term outcomes in terms of functional metrics from documented clinical data. Other objectives are to evaluate the outcomes in terms of radiological evaluation and of safety during all the follow-up.

Condition or Disease	Intervention/Treatment	Phase
Hallux Limitus of Left Great Toe; Rheumatoid Arthritis; Arthritis of 1st Metatarsophalangeal Joint; Osteoarthritis; Bunion; Hallux Limitus of Right Great Toe	Device: Primus FGTI (Flexible Great toe Implant)

Detailed Description

This is an observational post-marketing surveillance study, performed by 1 (one) investigator in 1 (one) Italian site.

• Preoperative and peroperative data were collected retrospectively.

• Postoperative data (minimum 5 years follow-up or until implant revision) were collected prospectively.

Study Design

• Study Type: Observational
• Actual Enrollment: 70 participants
• Observational Model: Cohort
• Official Title: A Post-Market Observational Study to Evaluate Safety and Performance of Primus™ FGT Implant at a Minimum of 5 Years Follow-up
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Outcome Measures

Primary Outcome Measures

1. AOFAS Hallux-MTP-IP Score - Overall [mean 6.9 years follow-up (range 5.2 - 9.5)]

   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".

2. AOFAS Hallux-MTP-IP - PAIN Score [mean follow-up of 6.9 years (range, 5.2 - 9.5)]

   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.

3. Pain at Passive Motion of MTP1 [mean follow-up of 6.9 years (range, 5.2 - 9.5)]

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

4. Pain at Pressure of MTP1 [mean follow-up of 6.9 years (range, 5.2 - 9.5)]

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

5. Walking Perimeter [mean follow-up of 6.9 years (range, 5.2 - 9.5)]

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

6. Pain During Walking [mean follow-up of 6.9 years (range, 5.2 - 9.5)]

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

7. Pain at Rest [mean follow-up of 6.9 years (range, 5.2 - 9.5)]

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

Secondary Outcome Measures

1. Osteolysis [mean 6.9 years (range, 5.5 - 9.5)]

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

2. Bone Resorption [mean 6.9 years (range, 5.5 - 9.5)]

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

3. Survival of the Implant. [mean follow-up of 6.9 years (range, 5.2 - 9.5)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patient has had a Primus™ FGT implantation for one of the following indications: hallux limitus, hallux rigidus, hallux abducto valgus associated with severe arthritis, unstable or painful joint from previous surgery on the great toe,

• patient having all necessary clinical and radiographical data available.,

• patient has been informed about this scientific study and has provided their Consent to participate.

Exclusion Criteria:

• patient does not have clinical and radiographic follow-up data available.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Casa Di Cura Villa Berica	Vicenza		Italy	36100

Sponsors and Collaborators

• Stryker Trauma GmbH

Investigators

• Principal Investigator: Stefano FIESCHI, MD, Casa di Cura Villa Berica - Vicenza - Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Trauma GmbH
• ClinicalTrials.gov Identifier: NCT02350881
• Other Study ID Numbers: 1202-T-FGTI-M
• First Posted: Jan 30, 2015
• Last Update Posted: Oct 31, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Arthritis; Hallux Limitus; Hallux Rigidus

Study Results

Participant Flow

Recruitment Details	Recruitment period : from September 2013 to April 2014

Arm/Group Title	Overall Cohort
Arm/Group Description	one consecutive series of patients were included
Period Title: Overall Study
STARTED	64
COMPLETED	64
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Cohort
Arm/Group Description	one consecutive series of patients were included
Overall Participants	64
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	59.8
Sex: Female, Male (Count of Participants)
Female	46 71.9%
Male	18 28.1%
Region of Enrollment (participants) [Number]
Italy	64 100%

Outcome Measures

1. Primary Outcome

Title	AOFAS Hallux-MTP-IP Score - Overall
Description	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".
Time Frame	mean 6.9 years follow-up (range 5.2 - 9.5)

Outcome Measure Data

Analysis Population Description

number of implants analyzed (70 implants in 64 patients)

Arm/Group Title	Overall Cohort
Arm/Group Description	one consecutive series of patients were included
Measure Participants	64
Measure Number of Implants	70
Mean (Standard Deviation) [units on a scale]	88.9 (9.1)

2. Primary Outcome

Title	AOFAS Hallux-MTP-IP - PAIN Score
Description	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.
Time Frame	mean follow-up of 6.9 years (range, 5.2 - 9.5)

Outcome Measure Data

Analysis Population Description

Overall cohort

Arm/Group Title	Overall Cohort
Arm/Group Description	one consecutive series of patients were included
Measure Participants	64
Measure Number of Implants	70
Mean (Standard Deviation) [units on a scale]	35.4 (5.0)

3. Primary Outcome

Title	Pain at Passive Motion of MTP1
Description	Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits.
Time Frame	mean follow-up of 6.9 years (range, 5.2 - 9.5)

Outcome Measure Data

Analysis Population Description

Overall cohort

Arm/Group Title	Absent	Moderate	Severe
Arm/Group Description	Number of patients reporting no pain	Number of patients reporting a moderate pain	Number of patients reporting a severe pain
Measure Participants	64	64	64
Measure Number of Implants	70	70	70
Preoperative	0	6	64
Postoperative	65	3	2

4. Secondary Outcome

Title	Osteolysis
Description	Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays.
Time Frame	mean 6.9 years (range, 5.5 - 9.5)

Outcome Measure Data

Analysis Population Description

Overall cohort

Arm/Group Title	Absence	Presence
Arm/Group Description	Number of feet where no osteolysis was observed	Number of feet where osteolysis was observed
Measure Participants	64	64
Measure Number of Implants	70	70
Number [percentage of implants]	81.4	18.6

5. Secondary Outcome

Title	Bone Resorption
Description	Bone resorption evaluation was described as : absent or present. Radiological evaluations were performed from available frontal and lateral view X-rays.
Time Frame	mean 6.9 years (range, 5.5 - 9.5)

Outcome Measure Data

Analysis Population Description

Overall cohort

Arm/Group Title	Absence	Presence
Arm/Group Description	Number of feet where no bone resorption was observed	Number of feet where bone resorption was observed
Measure Participants	64	64
Measure Number of Implants	70	70
Number [percentage of implants]	64.3	35.7

6. Primary Outcome

Title	Pain at Pressure of MTP1
Description	Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits.
Time Frame	mean follow-up of 6.9 years (range, 5.2 - 9.5)

Outcome Measure Data

Analysis Population Description

Overall cohort

Arm/Group Title	Absent	Moderate	Severe
Arm/Group Description	Number of patients reporting no pain	umber of patients reporting a moderate pain	Number of patients reporting a severe pain
Measure Participants	64	64	64
Measure Number of Implants	70	70	70
Preperative	0	16	54
Postoperative	61	8	1

7. Primary Outcome

Title	Walking Perimeter
Description	Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : "improved", "same", "worsened".
Time Frame	mean follow-up of 6.9 years (range, 5.2 - 9.5)

Outcome Measure Data

Analysis Population Description

Overall cohort

Arm/Group Title	Improved	Same	Worsened
Arm/Group Description	Number of patients who declared an improvement in their walking perimeter	Number of patients who declared no improvement in their walking perimeter	Number of patients who declared a worsening of their walking perimeter
Measure Participants	64	64	64
Measure Number of Implants	70	70	70
Number [Number of Implants]	59	11	0

8. Primary Outcome

Title	Pain During Walking
Description	Subjective evaluation by patients about pain during walking, postoperatively versus preoperatively. Patients had to choose among 4 variables : "disappeared", "less", same", "greater".
Time Frame	mean follow-up of 6.9 years (range, 5.2 - 9.5)

Outcome Measure Data

Analysis Population Description

Overall cohort

Arm/Group Title	Disappeared	Less	Same	Greater
Arm/Group Description	Number of patients who declared an absence of pain during walking postoperatively	Number of patients who declared a slight improvement of pain during walking postoperatively	Number of patients who declared no improvement in pain during walking postoperatively	Number of patients who declared a worsening of pain during walking postoperatively
Measure Participants	64	64	64	64
Measure Number of Implants	70	70	70	70
Number [Number of Implants]	55	15	0	0

9. Primary Outcome

Title	Pain at Rest
Description	Subjective evaluation of patients about ther pain at rest, postoperatively versus preoperatively. Patients had to choose among 4 variables : "disappeared", "less", "same, "greater".
Time Frame	mean follow-up of 6.9 years (range, 5.2 - 9.5)

Outcome Measure Data

Analysis Population Description

Overall cohort

Arm/Group Title	Disappeared	Less	Same	Greater
Arm/Group Description	Number of patients who declared an absence of pain at rest postoperatively	Number of patients who declared a slight improvement of pain at rest postoperatively	Number of patients who declared no improvement in pain at rest postoperatively	Number of patients who declared a worsening of pain at rest postoperatively
Measure Participants	64	64	64	64
Measure Number of Implants	70	70	70	70
Number [Number of Implants]	61	9	0	0

10. Secondary Outcome

Title	Survival of the Implant.
Description	The survival of the implant is evaluated according to the number of implant revisions or of reoperations, whatever the reason.
Time Frame	mean follow-up of 6.9 years (range, 5.2 - 9.5)

Outcome Measure Data

Analysis Population Description

Overall cohort

Arm/Group Title	Survival	Revisions
Arm/Group Description	Percentage of feet with implant still in place	Percentage of feet reoperated for implant ablation
Measure Participants	64	64
Measure Number of Implants	70	70
Number [percentage of implants]	100	0

Adverse Events

Time Frame	Adverse events were collected throughout the longest study follow-up, i.e. 144 months.
Arm/Group Title	Overall Cohort
Arm/Group Description	one consecutive series of patients were included
All Cause Mortality
	Overall Cohort
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Overall Cohort
	Affected / at Risk (%)	# Events
Total	0/64 (0%)
Other (Not Including Serious) Adverse Events
	Overall Cohort
	Affected / at Risk (%)	# Events
Total	1/64 (1.6%)
Infections and infestations
superficial skin infection around the wound	1/64 (1.6%)	1

Limitations/Caveats

inclusion of patients from only 1 site, operated by a single surgeon lack of control group for comparison with another treatment option inability to compare preoperative and postoperative AOFAS scores

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.