Clinical trial NCT00716508: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Patella Tendon Rupture
Keywords: Patella tendon rupute, suture anchors, repair patella tendon
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Outcome measures will include SF 36, Tegner and Lysholm scores, as well as IKDC scores.
timeFrame: Weeks 0-3, 4-6, 7-8, 12 and 16-24 after surgery:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Healthcare System
state: Georgia
Study officials:
affiliation: Emory University
name: William S Kimmerly, MD
role: PRINCIPAL_INVESTIGATOR
References: