Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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® |
- occurrence of device related complications [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
- 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 ]
| Estimated Enrollment: | 115 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | April 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 |
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
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| 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 | |
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: | October 9, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Switzerland: Ethikkommission South Africa: Human Research Ethics Committee Belgium: Institutional Review Board 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 May 23, 2013