Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®
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|ClinicalTrials.gov Identifier: NCT01284985|
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : September 11, 2014
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 or disease|
|Hallux Rigidus Hallux Limitus Hallux Valgus Osteoarthritis Rheumatoid Arthritis - Ankle and/or Foot|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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.
- occurrence of device related complications [ Time Frame: at 2 years ]
- improvement of the AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society) [ Time Frame: at 2 year ]
- Device related complications [ Time Frame: 1 year ]
- AOFAS HMIS score [ Time Frame: 1 year ]
- Quality of Life score [ Time Frame: overtime ]
- X-ray evaluation [ Time Frame: overtime ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284985
|Nemocnice Havlíčkův Brod|
|Havlíčkův Brod, Czech Republic, 580 22|
|Medisch Centrum Alkmaar|
|The Netcare and Linksfield Medical Centre|
|Johannesburg, South Africa|
|Hospital clinico y provincial|