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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01284985
Other study ID # RECON-EMEA-05
Secondary ID
Status Completed
Phase N/A
First received January 26, 2011
Last updated September 10, 2014
Start date February 2009
Est. completion date July 2013

Study information

Verified date September 2014
Source Integra LifeSciences Services
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)South Africa: Human Research Ethics CommitteeSpain: Comité Ético de Investigación ClínicaCzech Republic: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Czech Republic Nemocnice Havlíckuv Brod Havlíckuv Brod
Netherlands Medisch Centrum Alkmaar Alkmaar
South Africa The Netcare and Linksfield Medical Centre Johannesburg
Spain Hospital clinico y provincial Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Integra LifeSciences Services

Countries where clinical trial is conducted

Czech Republic,  Netherlands,  South Africa,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary occurrence of device related complications at 2 years Yes
Secondary improvement of the AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society) at 2 year No
Secondary Device related complications 1 year Yes
Secondary AOFAS HMIS score 1 year No
Secondary Quality of Life score overtime No
Secondary X-ray evaluation overtime No
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