Surgical Treatment for Acute Patella Tendon Rupture - Full Text View

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00716508

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 IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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 ]

Estimated Enrollment:	24
Study Start Date:	September 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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.
B: Active Comparator 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.

Arms

Assigned Interventions

A: Active Comparator

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.

B: Active Comparator

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.

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:

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.

Contacts and Locations

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

Contacts

Contact: Maria G Davila, MD	4047781566	maria.davila@emory.edu
Contact: Christin Chamberlain, ATC	4047781563	christin.chamberlain@emory.edu

Locations

United States, Georgia
Grady Healthcare System	Recruiting
Atlanta, Georgia, United States, 30303
Contact: Maria G Davila, MD 404-778-1566 maria.davila@emory.edu
Principal Investigator: William S Kimmerly, MD

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

William S Kimmerly, MD

Emory University

More Information

Responsible Party:	Emory University ( Scott Kimmerly, MD )
Study ID Numbers:	10200
Study First Received:	July 15, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00716508
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Patella tendon rupute, suture anchors, repair patella tendon

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Rupture

ClinicalTrials.gov processed this record on January 16, 2009