Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®

The great toe is vital for normal, pain free ambulation. Decreased function associated with osteoarthritis of the first matatarsal phalangeal joint (MTP I) often called Hallux Rigidis or Hallux Limitus leading to a painful great toe. Patients experience pain during ambulation especially during the push-off phase of gait. When surgery is indicated four techniques are used for hallux rigidis; cheilectomie, resection arthroplasty, arthrodesis and implant surgery (1). Endoprostetic implants are relatively new. Silicone Implants like the arthroplasty developed by Swanson (2) resulted in foreign body reactions and periarticular bone loss. Subsequent implants, in particular the metallic hemi arthroplasty with or without polyethylene articulations, have been more successful (3). Still, implants are prone to wear of the material and show higher rates of loosening and infection compared to other techniques (4;5). In the last decades several new implants are described using two non cemented pressfit components, of titanium alloy or ceramic (6-9). Between 2001 and 2004 the investigators developed a new concept with instrumentation for exact alignment to prevent for wear with loosening of the implant on the long term. The implant has bone-conserving characteristics to enable arthrodesis as a salvage procedure. It is a completely modular two-component press fit titanium alloy implant with polyethylene insert that can be used as either for hemi-, total- or revision arthroplasty.

The purpose of this study is to have an overview of clinical status of the patient implanted with the METIS® prosthesis at short term (2 years of follow-up). The objective of this study is to evaluate the safety and efficacy of the Metatarso-Phalangeal prosthesis METIS® at short term follow up.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Hallux Valgus; Hallux Rigidus; Hallux Limitus; Rheumatoid Arthritis - Ankle and/or Foot

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Czech Republic
  • Havlíčkův Brod, Czech Republic, 580 22
    • Nemocnice Havlíčkův Brod
• Netherlands
  • Alkmaar, Netherlands
    • Medisch Centrum Alkmaar
• South Africa
  • Johannesburg, South Africa
    • The Netcare and Linksfield Medical Centre
• Spain
  • Barcelona, Spain
    • Hospital Clinico Y Provincial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject who has an indication of:

• Hallux Rigidus;
• Hallux Limitus with degenerative joint disease;
• Painful Hallux Valgus;
• Osteoarthritis;
• Rheumatoid arthritis;
• Post-traumatic arthritis. For which surgeon has recommended that a METIS® prosthesis be implanted

Description

Inclusion Criteria:

• Age ≥ 18 years;
• Have willingness to give his/her data transfer authorisation;
• has an indication of: Hallux Rigidus, Hallux Limitus with degenerative joint disease, Painful Hallux Valgus, Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, for which surgeon has recommended that a METIS® prosthesis be implanted

Exclusion Criteria:

• active infection or inflammation;
• excessive bone loss, bone deficiency or rapid joint destruction;
• suspected or documented metal allergy or intolerance;
• metatarsal head or phalangeal avascular necrosis;
• joint instability involving soft and fibrous tissue deficiency;
• severe metatarso-phalangeal axis deviation (Hallux Valgus angle > 20°);
• prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol;
• a previous joint replacement.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
METIS; Patient who has an indication of : Hallux Rigidus, Hallux Limitus with degenerative joint disease, Painful Hallux Valgus, Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis and for which surgeon has recommended that a METIS® prosthesis be implanted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
occurrence of device related complications	at 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
improvement of the AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society)	at 2 year
Device related complications	1 year
AOFAS HMIS score	1 year
Quality of Life score	overtime
X-ray evaluation	overtime

Collaborators and Investigators

• Sponsor: Integra LifeSciences Services

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 26, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): September 11, 2014
• Last Update Submitted That Met QC Criteria: September 10, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Foot Injuries; Hallux Valgus; Hallux Rigidus; Hallux Limitus
• Other Study ID Numbers: RECON-EMEA-05