Achilles Tendon TearNCT00962143
Acute Achilles Repair With or Without OrthADAPT Augmentation
A study testing Achilles repair with OrthADAPT augmentation and Achilles repair without OrthADAPT Augmentation in people with Achilles Tendon Tear, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
The purpose of this study is to assess the clinical performance of the OrthADAPT Bioimplant in patients with acute mid-substance Achilles tendon tears requiring surgical repair. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Achilles Tendon Tear
- What is being tested?
- Achilles repair with OrthADAPT augmentation and Achilles repair without OrthADAPT Augmentation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jan 2011
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A transverse, full thickness, acute mid-substance Achilles tendon tear that requires surgical repair
- Achilles tendon tear is repairable by surgery using primary means as determined by intra-operative assessment
- Achilles tendon rupture with viable ends of the tendon that are suitable for primary repair
- Isolated Achilles tendon rupture without poly trauma
- Patient must be 18 to 70 years of age
- Life expectancy greater than or equal to 12 months
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- Patient is able to provide voluntary informed consent
- Patient is willing and able to return for all follow-up visits and study related exams
- Patient is willing to comply with prescribed physical therapy regimen
Who cannot join
- Emergency, poly trauma patients
- Previous Achilles tendon surgical procedure on that tendon
- Deficit in the contralateral extremity that prevents a comparison with the treated extremity
- Repair requires tendon lengthening, gap filling or tendon transfer
- BMI greater than 40
- Peripheral arterial disease
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- Uncontrolled Diabetes Mellitis
- Patients whose injury is known to involve litigation
- Known allergy to equine derived product
- Systemic collagen disease
- Neurological disease
- Active infection - systemic or at the intended surgical site
- Acute use of immunosuppressive agents
- Rupture resulting from fluoroquinolone induced tendinopathy
- Alcohol or drug abuse
- Participant in another investigational drug or device trial
- Pathologic soft tissue conditions that would prevent secure surgical fixation
- Patients who are unwilling or unable to return for follow-up visits and study related exams
- Pregnant women
- Cancer patients
- Decisionally impaired patients
- Institutionalized patients
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopaedic Institute of Central Jersey
Sea Girt, New Jersey, 08750
About this study
Official title: Prospective, Randomized, Multi-center: Acute Achilles Repair With or Without OrthADAPT Augmentation
The purpose of this study is to assess the clinical performance of the OrthADAPT Bioimplant in patients with acute mid-substance Achilles tendon tears requiring surgical repair.
- Conditions
- Achilles Tendon Tear
- Being tested
- Achilles repair with OrthADAPT augmentation, Achilles repair without OrthADAPT Augmentation
- Keywords
- Acute Achilles Tendon Tear, Acute Achilles Tendon Repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Achilles repair with OrthADAPT augmentationDevice
Achilles repair with OrthADAPT augmentation
Achilles repair without OrthADAPT AugmentationProcedure or surgery
Achilles repair without OrthADAPT Augmentation
| Study group | Role | What they receive |
|---|---|---|
| Achilles repair without OrthADAPT Augmentation | Active comparator | Achilles repair without OrthADAPT Augmentation Receives: Procedure: Achilles repair without OrthADAPT Augmentation |
| Achilles repair with OrthADAPT augmentation | Experimental | Achilles repair with OrthADAPT augmentation Receives: Device: Achilles repair with OrthADAPT augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb
Measured: 2, 3, 4.5, 6, and 12 months
Time to return to weight bearing
Measured: 2, 3, 4.5, 6, and 12 months
Time to return to full activity
Measured: 2, 3, 4.5, 6, and 12 months
Secondary outcomes (3)
Swelling, stiffness, pain, disease specific quality of life: SF-36, AOFAS Hindfoot scores
Measured: 6 weeks, 2, 3, 4.5, 6 and 12 months
Complication rate including re-rupture and incision wound healing delay
Measured: 6 weeks, 2, 3, 4.5, 6 and 12 months
Incidence of device and procedure-related adverse events
Measured: 6 weeks, 2, 3, 4.5, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2010 (estimated)
- Study completionJan 2011 (estimated)
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon TearStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Responsible party
- Sponsor
- Investigators
- Daniel Lee, DPM, Principal investigator, Department of Orthopaedic Surgery, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962143
- Sponsor's protocol ID
- P07-044-CR
- Status last verified
- Apr 2017
- First submitted
- 17 Aug 2009
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-center: Acute Achilles Repair With or Without OrthADAPT Augmentation
- ClinicalTrials.gov ID
- NCT00962143
- Acronym / sponsor ID
- P07-044-CR
- Conditions
- Achilles Tendon Tear
- Keywords
- Acute Achilles Tendon Tear, Acute Achilles Tendon Repair
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 19 Aug 2009 (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 purpose of this study is to assess the clinical performance of the OrthADAPT Bioimplant in patients with acute mid-substance Achilles tendon tears requiring surgical repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Achilles repair without OrthADAPT Augmentation | Active comparator | Procedure: Achilles repair without OrthADAPT AugmentationAchilles repair without OrthADAPT Augmentation |
| Achilles repair with OrthADAPT augmentation | Experimental | Device: Achilles repair with OrthADAPT augmentationAchilles repair with OrthADAPT augmentation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A transverse, full thickness, acute mid-substance Achilles tendon tear that requires surgical repair
- Achilles tendon tear is repairable by surgery using primary means as determined by intra-operative assessment
- Achilles tendon rupture with viable ends of the tendon that are suitable for primary repair
- Isolated Achilles tendon rupture without poly trauma
- Patient must be 18 to 70 years of age
Key exclusion criteria (23 listed)
- Emergency, poly trauma patients
- Previous Achilles tendon surgical procedure on that tendon
- Deficit in the contralateral extremity that prevents a comparison with the treated extremity
- Repair requires tendon lengthening, gap filling or tendon transfer
- BMI greater than 40
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 |
|---|---|---|
| Achilles repair with OrthADAPT augmentationAchilles repair with OrthADAPT augmentation | Device | Achilles repair with OrthADAPT augmentation |
| Achilles repair without OrthADAPT AugmentationAchilles repair without OrthADAPT Augmentation | Procedure or surgery | Achilles repair without OrthADAPT Augmentation |
Primary outcome
Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb
Time frame: 2, 3, 4.5, 6, and 12 months
Time to return to weight bearing
Time frame: 2, 3, 4.5, 6, and 12 months
Time to return to full activity
Time frame: 2, 3, 4.5, 6, and 12 months
3 secondary outcomes
Swelling, stiffness, pain, disease specific quality of life: SF-36, AOFAS Hindfoot scores
Time frame: 6 weeks, 2, 3, 4.5, 6 and 12 months
Complication rate including re-rupture and incision wound healing delay
Time frame: 6 weeks, 2, 3, 4.5, 6 and 12 months
Incidence of device and procedure-related adverse events
Time frame: 6 weeks, 2, 3, 4.5, 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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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.
Daniel Lee, DPM principal investigator
Department of Orthopaedic Surgery, UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Achilles repair with OrthADAPT augmentation and Achilles repair without OrthADAPT Augmentation in people with Achilles Tendon Tear, run by Baxter Healthcare Corporation 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 9 inclusion and 23 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: withdrawn, as of the sponsor's last update on 5 Apr 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb (time frame: 2, 3, 4.5, 6, and 12 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 5 Apr 2017.