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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services
ClinicalTrials.gov Identifier:
NCT01284985
First received: January 26, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Services:

Primary Outcome Measures:
  • occurrence of device related complications [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • improvement of the AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society) [ Time Frame: at 2 year ] [ Designated as safety issue: No ]
  • Device related complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • AOFAS HMIS score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of Life score [ Time Frame: overtime ] [ Designated as safety issue: No ]
  • X-ray evaluation [ Time Frame: overtime ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284985

Locations
Czech Republic
Nemocnice Havlíčkův Brod
Havlíčkův Brod, Czech Republic, 580 22
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands
South Africa
The Netcare and Linksfield Medical Centre
Johannesburg, South Africa
Spain
Hospital clinico y provincial
Barcelona, Spain
Sponsors and Collaborators
Integra LifeSciences Services
  More Information

No publications provided

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT01284985     History of Changes
Other Study ID Numbers: RECON-EMEA-05
Study First Received: January 26, 2011
Last Updated: December 11, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
South Africa: Human Research Ethics Committee
Spain: Comité Ético de Investigación Clínica
Czech Republic: Ethics Committee

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Hallux Valgus
Osteoarthritis
Hallux Rigidus
Hallux Limitus
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Foot Deformities
Foot Deformities, Acquired

ClinicalTrials.gov processed this record on July 29, 2014