Surgical Treatment for Acute Patella Tendon Rupture

Acute Patella Tendon Rupture Clinical Trial

Official title:

Surgical Treatment for Acute Patella Tendon Rupture: a Prospective, Randomized Study Comparing Transpatellar Suture Tunnels Method vs. Suture Anchors.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00716508
• Other study ID #: IRB00010200
• Status: Terminated
• Phase: Phase 4
• First received: July 15, 2008
• Last updated: September 17, 2013
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Patella Tendon Rupture
• Rupture

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Grady Healthcare System	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome measures will include SF 36, Tegner and Lysholm scores, as well as IKDC scores.		Weeks 0-3, 4-6, 7-8, 12 and 16-24 after surgery:	Yes