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Completed

NCT Number: NCT02350881

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

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.

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Key information

Conditions

Hallux Limitus of Left Great Toe Arthritis Arthritis of 1st Metatarsophalangeal Joint Arthritis, Rheumatoid Autoimmune Diseases Bunion Connective Tissue Diseases Foot Deformities Foot Deformities, Acquired Hallux Limitus of Right Great Toe Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Casa Di Cura Villa Berica

Vicenza, 36100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primus FGTI (Flexible Great toe Implant)

Device

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.

Other names: First metatarsophalangeal arthroplasty

Primary outcomes

  1. 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".

  2. 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.

  3. 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.

  4. 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.

  5. 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".

  6. 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".

  7. 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".

Secondary outcomes

  1. Osteolysis

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stryker Trauma and Extremities

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2015
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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