Surgical Treatment for Acute Patella Tendon Rupture

This study has been terminated.
(Our PI left our institutions as we could not longer continue.)
Sponsor:
Information provided by (Responsible Party):
Kyle Webb, Emory University
ClinicalTrials.gov Identifier:
NCT00716508
First received: July 15, 2008
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Acute Patella Tendon Rupture
Procedure: Repair with transpatellar tunnels
Procedure: Repair with suture anchors.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Treatment for Acute Patella Tendon Rupture: a Prospective, Randomized Study Comparing Transpatellar Suture Tunnels Method vs. Suture Anchors.

Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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: ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Repair with suture anchors.
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.
Other Name: Unknown
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.
Procedure: Repair with transpatellar tunnels
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.
Other Name: Unknown

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716508

Locations
United States, Georgia
Grady Healthcare System
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: William S Kimmerly, MD Emory University
  More Information

No publications provided

Responsible Party: Kyle Webb, Research Administrator, Emory University
ClinicalTrials.gov Identifier: NCT00716508     History of Changes
Other Study ID Numbers: IRB00010200
Study First Received: July 15, 2008
Last Updated: September 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Patella tendon rupute, suture anchors, repair patella tendon

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014