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

NCT02350881 | Completed Results

• 1 other identifier: 1202-T-FGTI-M
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Limitus of Left Great Toe; Rheumatoid Arthritis; Arthritis of 1st Metatarsophalangeal Joint; Osteoarthritis; Bunion; Hallux Limitus of Right Great Toe

Outcome Measures

Primary Outcomes (7)

• 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".

  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.

  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.

  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.

  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".

  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".

  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".

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

Secondary Outcomes (3)

• Osteolysis

  mean 6.9 years (range, 5.5 - 9.5)

• Bone Resorption

  mean 6.9 years (range, 5.5 - 9.5)

• Survival of the Implant.

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

Interventions

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.

Also known as: First metatarsophalangeal arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (1)

Casa Di Cura Villa Berica

Vicenza, Vicenza, 36100, Italy

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Bunion

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Foot Deformities, Acquired; Foot Deformities

Limitations and 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

Results Point of Contact

• Title: Dr Stefano Fieschi
• Organization: Casa di Cura VIlla Berica

stefanofieschi@gmail.com

Study Officials

• Stefano FIESCHI, MD

  Casa di Cura Villa Berica - Vicenza - Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 30, 2015
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 31, 2016
• Results First Posted: October 31, 2016

Record last verified: 2016-05

Locations

IT (1)