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

NCT01284985 | Completed

• 1 other identifier: RECON-EMEA-05
• Study Type: observational
• Target: 60
• Locations: 4 countries
• Sites: 4

Brief Summary

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.

Conditions

Hallux Rigidus; Hallux Limitus; Hallux Valgus; Osteoarthritis; Rheumatoid Arthritis - Ankle and/or Foot

Outcome Measures

Primary Outcomes (1)

• occurrence of device related complications

  at 2 years

Secondary Outcomes (5)

• 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

Study Arms (1)

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.

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

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integra LifeSciences Services: lead

Study Sites (4)

Nemocnice Havlíčkův Brod

Havlíčkův Brod, 580 22, Czechia

Location

Medisch Centrum Alkmaar

Alkmaar, Netherlands

Location

The Netcare and Linksfield Medical Centre

Johannesburg, South Africa

Location

Hospital clinico y provincial

Barcelona, Spain

Location

MeSH Terms

Conditions

Hallux Rigidus; Hallux Limitus; Hallux Valgus; Osteoarthritis

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases; Foot Injuries; Leg Injuries; Wounds and Injuries; Arthritis; Rheumatic Diseases

Study Design

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

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 27, 2011
• Study Start: February 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

ES (1); ZA (1); CZ (1); NL (1)