Hallux Limitus of Left Great ToeNCT02350881

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

An observational study of Hallux Limitus of Left Great Toe and Rheumatoid Arthritis, run by Stryker Trauma and Extremities at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hallux Limitus of Left Great Toe, Rheumatoid Arthritis, Arthritis of 1st Metatarsophalangeal Joint
What is being tested?: Primus FGTI (Flexible Great toe Implant)
Type of treatment: Medical device
How many people: 70 participants
Where: 1 siteItaly
Study dates: May 2013to Nov 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: This study has included all patients who had had a Primus™ FGT implantation.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Casa Di Cura Villa Berica
Vicenza, Vicenza, 36100

Other trials in Italy

About this study

Official title: A Post-Market Observational Study to Evaluate Safety and Performance of Primus™ FGT Implant at a Minimum of 5 Years Follow-up

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.

Read the 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.

Conditions: Hallux Limitus of Left Great Toe, Rheumatoid Arthritis, Arthritis of 1st Metatarsophalangeal Joint, Osteoarthritis, Bunion, Hallux Limitus of Right Great Toe
Being tested: Primus FGTI (Flexible Great toe Implant)
Medical subject headings: Arthritis, Rheumatoid, Osteoarthritis, Bunion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Primus FGTI (Flexible Great toe Implant)Device
Also called First metatarsophalangeal arthroplasty
Great toe arthroplasty consists of replacing the first Meta-Tarso-Phalangeal (MTP1) joint by a two hinged prosthesis made of silicone : the Primus FGT implant (FGTI). The Primus is designed with an axially offset hinge to align with the anatomy of the MTP joint. This results in less implant stresses and improved toe function.

What is being measured

The primary outcome is the main question the study is designed to answer.

AOFAS Hallux-MTP-IP Score - Overall
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".
Measured: mean 6.9 years follow-up (range 5.2 - 9.5)
AOFAS Hallux-MTP-IP - PAIN Score
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.
Measured: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Pain at Passive Motion of MTP1
Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits.
Measured: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Pain at Pressure of MTP1
Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits.
Measured: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Walking Perimeter
Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : "improved", "same", "worsened".
Measured: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Pain During Walking
Subjective evaluation by patients about pain during walking, postoperatively versus preoperatively. Patients had to choose among 4 variables : "disappeared", "less", same", "greater".
Measured: mean follow-up of 6.9 years (range, 5.2 - 9.5)
Pain at Rest
Subjective evaluation of patients about ther pain at rest, postoperatively versus preoperatively. Patients had to choose among 4 variables : "disappeared", "less", "same, "greater".
Measured: mean follow-up of 6.9 years (range, 5.2 - 9.5)

Secondary outcomes (3)

Osteolysis
Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays.
Measured: mean 6.9 years (range, 5.5 - 9.5)
Bone Resorption
Bone resorption evaluation was described as : absent or present. Radiological evaluations were performed from available frontal and lateral view X-rays.
Measured: mean 6.9 years (range, 5.5 - 9.5)
Survival of the Implant.
The survival of the implant is evaluated according to the number of implant revisions or of reoperations, whatever the reason.
Measured: mean follow-up of 6.9 years (range, 5.2 - 9.5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Nov 2014

First posted30 Jan 2015 (estimated)
Study startMay 2013
Primary completionJun 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hallux Limitus of Left Great ToeStudies of the same condition, open and under way.
More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02350881
Sponsor's protocol ID: 1202-T-FGTI-M
Status last verified: May 2016
First submitted: 19 Jan 2015
Last updated: 31 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Market Observational Study to Evaluate Safety and Performance of Primus™ FGT Implant at a Minimum of 5 Years Follow-up
ClinicalTrials.gov ID: NCT02350881
Acronym / sponsor ID: 1202-T-FGTI-M
Conditions: Hallux Limitus of Left Great Toe, Rheumatoid Arthritis, Arthritis of 1st Metatarsophalangeal Joint, Osteoarthritis, Bunion, Hallux Limitus of Right Great Toe
Study type: Observational
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Jun 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 30 Jan 2015 (estimated)
Results: Posted 31 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Observational model: Cohort

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study has included all patients who had had a Primus™ FGT implantation.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Primus FGTI (Flexible Great toe Implant)Also: First metatarsophalangeal arthroplastyGreat toe arthroplasty consists of replacing the first Meta-Tarso-Phalangeal (MTP1) joint by a two hinged prosthesis made of silicone : the Primus FGT implant (FGTI). The Primus is designed with an axially offset hinge to align with the anatomy of the MTP joint. This results in less implant stresses and improved toe function.	Device	–

Primary outcome

AOFAS Hallux-MTP-IP Score - Overall
Time frame: 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".
AOFAS Hallux-MTP-IP - PAIN Score
Time frame: 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.
Pain at Passive Motion of MTP1
Time frame: 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.
Pain at Pressure of MTP1
Time frame: 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.
Walking Perimeter
Time frame: 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".
Pain During Walking
Time frame: 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".
Pain at Rest
Time frame: 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".

3 secondary outcomes

Osteolysis
Time frame: mean 6.9 years (range, 5.5 - 9.5)
Bone Resorption
Time frame: mean 6.9 years (range, 5.5 - 9.5)
Survival of the Implant.
Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5)

Results and safety

Results posted to the registry on 31 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Cohort	64	64

Primary outcome: AOFAS Hallux-MTP-IP Score - Overall

Time frame: mean 6.9 years follow-up (range 5.2 - 9.5). Mean (Standard Deviation). Unit: units on a scale

Measure	Overall Cohort n = 64
Value	88.9 (9.1)

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

Primary outcome: AOFAS Hallux-MTP-IP - PAIN Score

Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5). Mean (Standard Deviation). Unit: units on a scale

Measure	Overall Cohort n = 64
Value	35.4 (5.0)

Population analysed: Overall cohort

Primary outcome: Pain at Passive Motion of MTP1

Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5). Number. Unit: Number of Implants

Measure	Absent n = 64	Moderate n = 64	Severe n = 64
Preoperative	0	6	64
Postoperative	65	3	2

Population analysed: Overall cohort

Primary outcome: Pain at Pressure of MTP1

Time frame: mean follow-up of 6.9 years (range, 5.2 - 9.5). Number. Unit: Number of Implants

Measure	Absent n = 64	Moderate n = 64	Severe n = 64
Preperative	0	16	54
Postoperative	61	8	1

Population analysed: Overall cohort

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the longest study follow-up, i.e. 144 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Cohort	0 of 64 (0%)	1 of 64 (1.6%)	Not reported

Limitations and caveats (from the sponsor): * 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stefano FIESCHI, MD principal investigator

Casa di Cura Villa Berica - Vicenza - Italy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hallux Limitus of Left Great Toe and Rheumatoid Arthritis, run by Stryker Trauma and Extremities at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AOFAS Hallux-MTP-IP Score - Overall (time frame: mean 6.9 years follow-up (range 5.2 - 9.5)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02350881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.