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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284985
• Other study ID #: RECON-EMEA-05
• 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

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

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