Achilles Tendon RuptureNCT01237613
Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
A study testing Artelon in people with Achilles Tendon Rupture, run by Orthopedic Foot and Ankle Center, Ohio at 1 site in United States.
Trial summary
The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with regard to lower leg and foot function, pain and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Artelon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- The patient has a clinically confirmed isolated chronic rupture or rerupture of the Achilles tendon.
- The patient has been informed about the study and signed the patient consent form.
- The patient reads, understands and is able to complete the study questionnaires in English.
Who cannot join
- The patient has an ongoing infection of the soft tissues of the ankle.
- The patient has evidence of severe ankle arthritis.
- The patient has a multi-system or multi-limb trauma.
- The patient has a major medical condition that would affect quality of life and influence the results of the study.
- The patient is pregnant
- The patient is not expected to complete the study according to the investigation plan.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Foot and Ankle Center
Westerville, Ohio, 43082
About this study
The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with regard to lower leg and foot function, pain and quality of life.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Artelon
- Keywords
- Achilles, Rupture, Tendon, Artelon
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtelonDevice
Artelon Tissue Reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Artelon | Experimental | This is an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement. Receives: Device: Artelon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
Measured: 3 months
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
Measured: 6 months
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
Measured: 12 months
Secondary outcomes (18)
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
Measured: 3 months
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Measured: 3 months
Range of Motion, Strength and Calf Circumference
Measured: 3 months
Subjective Evaluation of Treatment
Measured: 3 months
Return to Work and Previous Physical Activities
Measured: 3 months
Clinical Evaluation Including Adverse Events
Measured: 3 months
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
Measured: 6 months
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Measured: 6 months
Range of Motion, Strength and Calf Circumference
Measured: 6 months
Subjective Evaluation of Treatment
Measured: 6 months
Return to Work and Previous Physical Activities
Measured: 6 months
Clinical Evaluation Including Adverse Events
Measured: 6 months
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
Measured: 12 months
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Measured: 12 months
Range of Motion, Strength and Calf Circumference
Measured: 12 months
Subjective Evaluation of Treatment
Measured: 12 months
Return to Work and Previous Physical Activities
Measured: 12 months
Clinical Evaluation Including Adverse Events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Sponsoring company declared bankrupty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Achilles Tendon RuptureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedic Foot and Ankle Center, Ohio
- Sponsor type
- University, hospital or other
- Collaborators
- Artimplant AB
- Responsible party
- Sponsor
- Investigators
- Terrence M Philbin, DO, Principal investigator, Orthopedic Foot and Ankle Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237613
- Sponsor's protocol ID
- KP027ext
- Status last verified
- Jun 2015
- First submitted
- 16 Sep 2010
- Last updated
- 22 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
- ClinicalTrials.gov ID
- NCT01237613
- Acronym / sponsor ID
- KP027ext
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles, Rupture, Tendon, Artelon
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsoring company declared bankrupty
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Orthopedic Foot and Ankle Center, OhioUniversity, hospital or other
- Collaborators
- Artimplant AB
- Study start
- Nov 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Posted 27 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with regard to lower leg and foot function, pain and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artelon | Experimental | Device: ArtelonThis is an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient has a clinically confirmed isolated chronic rupture or rerupture of the Achilles tendon.
- The patient has been informed about the study and signed the patient consent form.
- The patient reads, understands and is able to complete the study questionnaires in English.
Key exclusion criteria (6 listed)
- The patient has an ongoing infection of the soft tissues of the ankle.
- The patient has evidence of severe ankle arthritis.
- The patient has a multi-system or multi-limb trauma.
- The patient has a major medical condition that would affect quality of life and influence the results of the study.
- The patient is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArtelonArtelon Tissue Reinforcement | Device | Artelon |
Primary outcome
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
Time frame: 3 months
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
Time frame: 6 months
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
Time frame: 12 months
18 secondary outcomes
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
Time frame: 3 months
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Time frame: 3 months
Range of Motion, Strength and Calf Circumference
Time frame: 3 months
Subjective Evaluation of Treatment
Time frame: 3 months
Return to Work and Previous Physical Activities
Time frame: 3 months
Clinical Evaluation Including Adverse Events
Time frame: 3 months
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
Time frame: 6 months
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Time frame: 6 months
Range of Motion, Strength and Calf Circumference
Time frame: 6 months
Subjective Evaluation of Treatment
Time frame: 6 months
Return to Work and Previous Physical Activities
Time frame: 6 months
Clinical Evaluation Including Adverse Events
Time frame: 6 months
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
Time frame: 12 months
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Time frame: 12 months
Range of Motion, Strength and Calf Circumference
Time frame: 12 months
Subjective Evaluation of Treatment
Time frame: 12 months
Return to Work and Previous Physical Activities
Time frame: 12 months
Clinical Evaluation Including Adverse Events
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Achilles Tendon Rupture
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Early Functional Outcomes After Open Versus Percutaneous Repair of Acute Achilles Tendon Ruptures
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Recruiting
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Achilles Tendon Rupture
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
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Achilles Tendon Rupture Patient Outcomes at 12 Months
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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.
Terrence M Philbin, DO principal investigator
Orthopedic Foot and Ankle Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artelon in people with Achilles Tendon Rupture, run by Orthopedic Foot and Ankle Center, Ohio at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 27 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability (time frame: 3 months). The study lists 3 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 22 Jul 2015.