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Surgical Treatment for Acute Patella Tendon Rupture

Primary Purpose

Acute Patella Tendon Rupture

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Repair with transpatellar tunnels
Repair with suture anchors.
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Patella Tendon Rupture focused on measuring Patella tendon rupute, suture anchors, repair patella tendon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grady Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Outcome measures will include SF 36, Tegner and Lysholm scores, as well as IKDC scores.

Secondary Outcome Measures

Full Information

First Posted
July 15, 2008
Last Updated
September 17, 2013
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00716508
Brief Title
Surgical Treatment for Acute Patella Tendon Rupture
Official Title
Surgical Treatment for Acute Patella Tendon Rupture: a Prospective, Randomized Study Comparing Transpatellar Suture Tunnels Method vs. Suture Anchors.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Our PI left our institutions as we could not longer continue.
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We will compare two groups for acute patella tendon repair: one treated with surgical anchors and the second, with transpatellar tunnels.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Patella Tendon Rupture
Keywords
Patella tendon rupute, suture anchors, repair patella tendon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Repair with transpatellar tunnels
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Repair with suture anchors.
Intervention Description
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.
Primary Outcome Measure Information:
Title
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:

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William S Kimmerly, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Healthcare System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

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Surgical Treatment for Acute Patella Tendon Rupture

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