Hammer ToeNCT01285011
Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant
An observational study of Hammer Toe and Claw Toe, run by Integra LifeSciences Services at 5 sites in 3 countries.
Trial summary
Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the most frequently affected, but the other small toes may also be involved. When nonoperative treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the Proximal Interphalangeal (PIP) joint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hammer Toe, Claw Toe, Shortening 2nd Toe
- How many people
- 156 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Apr 2009to Jul 2012
- 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: Any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal Interphalangeal Implant Ipp-On be implanted
Who may be able to join
- Any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal Interphalangeal Implant Ipp-On be implanted
- Age >= 18 years
- Have willingness to give his/her Data Transfer Authorization
Who cannot join
- Contraindication of the implantation of the Ipp-On The implant should not be used in a patient who has currently, or who has a history of: • Active local or systemic infection
- Severe peripheral vascular disease
- Severe longitudinal deformity
- Insufficient quantity or quality of bone to permit stabilization of the arthrodesis
- Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process
- Suspected or documented metal allergy or intolerance.
- History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
About this study
Official title: Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal
Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the most frequently affected, but the other small toes may also be involved. When nonoperative treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the Proximal Interphalangeal (PIP) joint. This arthrodesis is technically demanding, its needs:
- Internal fixation;
- Interphalangeal Compression;
- Anatomic PIP joint plantar flexion angle. The implant Ipp-On has been developed for this specific arthrodesis. The objective of this study is to evaluate the efficacy and safety of the Proximal Interphalangeal Implant: Ipp-On at short term follow up.
Read more
The safety of the Ipp-On will be described in terms of rate of device related complications.
The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months.
- Keywords
- arthrodesis, PIP joint
- Medical subject headings
- Hammer Toe Syndrome, Ankylosis
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 |
|---|---|---|
| Ipp-On | Patient implanted with the Ipp-On |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device related complications
Measured: 12 months
fusion rate
Measured: 6 months
Secondary outcomes (5)
Fusion rate
Measured: 3 months
American Orthopaedic Foot and Ankle Society Lesser Metatarsophalangeal Scale (AOFAS LMIS) score
Measured: 6 months/12 months
Radiological Evaluation
Measured: 6 months/12 months
Clinical Assessment
Measured: 6 months/12 months
Subjective assessment
Measured: 6 months/12 months
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 startApr 2009
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hammer ToeStudies 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
- 156 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
- NCT01285011
- Sponsor's protocol ID
- RECON-EMEA-08
- 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 Proximal Interphalangeal
- ClinicalTrials.gov ID
- NCT01285011
- Acronym / sponsor ID
- RECON-EMEA-08
- Keywords
- arthrodesis, PIP joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Integra LifeSciences ServicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (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.
Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the most frequently affected, but the other small toes may also be involved. When nonoperative treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the Proximal Interphalangeal (PIP) joint. This arthrodesis is technically demanding, its needs:
- Internal fixation;
- Interphalangeal Compression;
- Anatomic PIP joint plantar flexion angle. The implant Ipp-On has been developed for this specific arthrodesis. The objective of this study is to evaluate the efficacy and safety of the Proximal Interphalangeal Implant: Ipp-On at short term follow up.
The safety of the Ipp-On will be described in terms of rate of device related complications.
The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipp-On | – | –Patient implanted with the Ipp-On |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal Interphalangeal Implant Ipp-On be implanted
Key inclusion criteria (3 listed)
- Any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal Interphalangeal Implant Ipp-On be implanted
- Age >= 18 years
- Have willingness to give his/her Data Transfer Authorization
Key exclusion criteria (7 listed)
- Contraindication of the implantation of the Ipp-On The implant should not be used in a patient who has currently, or who has a history of: • Active local or systemic infection
- History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
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
Rate of device related complications
Time frame: 12 months
fusion rate
Time frame: 6 months
5 secondary outcomes
Fusion rate
Time frame: 3 months
American Orthopaedic Foot and Ankle Society Lesser Metatarsophalangeal Scale (AOFAS LMIS) score
Time frame: 6 months/12 months
Radiological Evaluation
Time frame: 6 months/12 months
Clinical Assessment
Time frame: 6 months/12 months
Subjective assessment
Time frame: 6 months/12 months
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.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hammer Toe and Claw Toe, run by Integra LifeSciences Services at 5 sites in 3 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 7 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 5 sites in France, Belgium, Switzerland. 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?
Rate of device related complications (time frame: 12 months). The study lists 2 primary outcomes in all. 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.