- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00716508
Surgical Treatment for Acute Patella Tendon Rupture
September 17, 2013 updated by: Kyle Webb, Emory University
Surgical Treatment for Acute Patella Tendon Rupture: a Prospective, Randomized Study Comparing Transpatellar Suture Tunnels Method vs. Suture Anchors.
We will compare two groups for acute patella tendon repair: one treated with surgical anchors and the second, with transpatellar tunnels.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The patella tendon is located in the knee, and is attached to the leg bone and the patella bone (knee cap).
The quadriceps muscle (an important tight muscle) attaches to the patella bone and allows for extension and flexion of the leg.
Rupture of the patella tendon occurs mainly in people under the age of 40 years old with an active lifestyle.
Normally, surgical repair is needed to fix this injury.
The widely accepted surgery for this injury consists in drilling 2 holes in the patella bone that are used to anchor the patella tendon in place.
This surgery has some complications such as re-rupture of the tendon, breakage of the bone, etc.
Some investigators have tried different techniques to avoid these complications with variable results.
We want to use 2 anchors in the bone to avoid making holes in the patella bone, decreasing complications and surgical time, and hopefully, allowing for a better surgical repair.
We will have 2 arms.
One group will have the standard of care technique and the second group will have the anchors technique.
We will follow up with our patients after the surgery to record their progress, and complications, if any.
We will also have a standardized physical therapy program for consistency and to avoid any problems.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30303
- Grady Healthcare System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stage of Disease: Acute ruptures of the patella tendon, no more than 3 weeks since the time of injury.
- Age: 18 years old and up.
- Performance status: Patients with no other previous illnesses that prevented them to ambulate normally (without help of devices).
- 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:
- Prior treatment: Patients with chronic patella tendon ruptures (more than 3 weeks).
- Prior other diseases: diseases with systemic collagen deficiencies.
- Infection: Patients with active infection will be disqualified.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Repair with suture anchors: The insertion points for the three suture anchors will be marked with electrocautery.
The anchors will be placed approximately 2 mm from the articulate surface; placing them too superficially may increased the joint reactive force and lead to abnormal patella femora joint mechanics.
Pilot holes will be drilled with a 3.2-mm drill bit parallel to the patella, avoiding penetration of the articular surface.
Three Suture anchors (Arthrex, Naples FL) will be threaded with two No. 5 Fiberwire (Arthrex, Naples FL) sutures and will be inserted and deployed in the pilot holes in the usual manner.
|
Repair with suture anchors: The insertion points for the three suture anchors will be marked with electrocautery.
The anchors will be placed approximately 2 mm from the articulate surface; placing them too superficially may increased the joint reactive force and lead to abnormal patella femora joint mechanics.
Pilot holes will be drilled with a 3.2-mm drill bit parallel to the patella, avoiding penetration of the articular surface.
Three Suture anchors (Arthrex, Naples FL) will be threaded with two No. 5 Fiberwire (Arthrex, Naples FL) sutures and will be inserted and deployed in the pilot holes in the usual manner.
|
Active Comparator: B
Repair with transpatellar tunnels: We will make a small horizontal trough at the inferior pole of the patella.
Multiple, braided Krackow sutures will then be placed through the substance of the tendon using no. 5 Fiberwire (Arthrex, Naples FL) suture.
Three to four drill holes will then be made through the patella.
Using a suture passer, the sutures will then be brought from distal to proximal and tied over the superior pole.
The knee will be flexed to 45 degrees.
The tendon will be repaired adjacent to the articular surface and not to the anterior surface of the patella.
|
Repair with transpatellar tunnels: We will make a small horizontal trough at the inferior pole of the patella.
Multiple, braided Krackow sutures will then be placed through the substance of the tendon using no. 5 Fiberwire (Arthrex, Naples FL) suture.
Three to four drill holes will then be made through the patella.
Using a suture passer, the sutures will then be brought from distal to proximal and tied over the superior pole.
The knee will be flexed to 45 degrees.
The tendon will be repaired adjacent to the articular surface and not to the anterior surface of the patella.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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:
|
Weeks 0-3, 4-6, 7-8, 12 and 16-24 after surgery:
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William S Kimmerly, MD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
July 15, 2008
First Submitted That Met QC Criteria
July 15, 2008
First Posted (Estimate)
July 16, 2008
Study Record Updates
Last Update Posted (Estimate)
September 19, 2013
Last Update Submitted That Met QC Criteria
September 17, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00010200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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