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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00716508 |
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Date of registration:
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15/07/2008 |
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Primary sponsor: |
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Public title:
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Surgical Treatment for Acute Patella Tendon Rupture
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Scientific title:
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Surgical Treatment for Acute Patella Tendon Rupture: a Prospective, Randomized Study Comparing Transpatellar Suture Tunnels Method vs. Suture Anchors. |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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24 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00716508 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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William S Kimmerly, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Stage of Disease: Acute ruptures of the patella tendon, no more than 3 weeks since
the time of injury.
2. Age: 18 years old and up.
3. Performance status: Patients with no other previous illnesses that prevented them to
ambulate normally (without help of devices).
4. Informed consent requirements: One person from our research staff will approach the
patient after the diagnosis has been made. The diagnosis will be made by the doctor
in charge on the patient care based on the medical history, physical exam and image
studies (MRI). We will explain the benefits/risks to be part of the study and that
they are not obligated to be part of it as part of their care.
Exclusion Criteria:
1. Prior treatment: Patients with chronic patella tendon ruptures (more than 3 weeks).
2. Prior other diseases: diseases with systemic collagen deficiencies.
3. Infection: Patients with active infection will be disqualified.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Patella Tendon Rupture
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Intervention(s)
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Procedure: Repair with suture anchors.
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Procedure: Repair with transpatellar tunnels
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Primary Outcome(s)
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Outcome measures will include SF 36, Tegner and Lysholm scores, as well as IKDC scores.
[Time Frame: Weeks 0-3, 4-6, 7-8, 12 and 16-24 after surgery:]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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