Hallux RigidusNCT01284985
Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®
An observational study of Hallux Rigidus and Hallux Limitus, run by Integra LifeSciences Services at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Rigidus, Hallux Limitus, Hallux Valgus
- How many people
- 60 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2009to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
South Africa1 site
The Netcare and Linksfield Medical Centre
Johannesburg
About this study
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.
- Conditions
- Hallux Rigidus, Hallux Limitus, Hallux Valgus, Osteoarthritis, Rheumatoid Arthritis - Ankle and/or Foot
- Medical subject headings
- Hallux Rigidus, Hallux Limitus, Hallux Valgus, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of device related complications
Measured: at 2 years
Secondary outcomes (5)
improvement of the AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale (HMIS) score (American Orthopaedic Foot and Ankle Society)
Measured: at 2 year
Device related complications
Measured: 1 year
AOFAS HMIS score
Measured: 1 year
Quality of Life score
Measured: overtime
X-ray evaluation
Measured: overtime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startFeb 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux RigidusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284985
- Sponsor's protocol ID
- RECON-EMEA-05
- Status last verified
- Sep 2014
- First submitted
- 26 Jan 2011
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®
- ClinicalTrials.gov ID
- NCT01284985
- Acronym / sponsor ID
- RECON-EMEA-05
- Conditions
- Hallux Rigidus, Hallux Limitus, Hallux Valgus, Osteoarthritis, Rheumatoid Arthritis - Ankle and/or Foot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Integra LifeSciences ServicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of device related complications
Time frame: at 2 years
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Rigidus and Hallux Limitus, run by Integra LifeSciences Services at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia, Netherlands, South Africa, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of device related complications (time frame: at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.