Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Granada
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- change of Isokinetic strenght test
Study Overview
Brief Summary
The purpose of this CRT study is to compare clinical and functional outcomes of three graft types ( Quadriceps tendon with bone versus Hamstring tendon versus Quadriceps tendon without bone) for reconstration of anterior cruciate ligament among football players.
Detailed Description
In the previous studies patellar tendon and hamstring tendon were the most investigated graft types. While quadriceps tendon has been investigated a fewer times. And to our knowledge there is no control study that compare quadriceps tendon-patellar bone autograft with Quadriceps Autograft and Hamstring Autograft as control randomized study.
All of the patients will be examined before of the surgery and 3, 6, 12, 24 months after the surgery to compare the outcome of differnt graft types. While a secand aim of this study is to examen the effect of rehabilitation protocol on the short and long term within all of the clinical and the functional outcomes.
The rehabilitation protocol will contain one phase before the surgery and four phases after the surgery.The goal of the first phase will be pain and inflammation control, increase ROM and muscle strength will be during the second and the third phases.In the last phase all of the players have to achieve maximum muscle strength and neuromuscular control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
the researcher will evaluate each patient without knowing the type of grafting that will be applied
Eligibility Criteria
- Ages
- 16 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with ACL injury susceptible to receive a surgical reconstruction.
- •Autograft with Hamstring tendon ,quadriceps tendon or quadriceps tendon with patellar bone.
- •Soccer player for more than 3 years.
- •Between 16 and 40 years old.
Exclusion Criteria
- •Patient with previous joint injury.
- •Patient with previous surgery on the affected knee.
- •patient with previous musculoskeletal injury (4 weeks)
- •Patient with untreated chronic injury.
Arms & Interventions
Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT
Quadriceps tendon without bone will be used as graft for the surgery.
Intervention: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT (Procedure)
Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT
Quadriceps tendon without bone will be used as graft for the surgery.
Intervention: Rehabilitation protocol (Other)
Arm 1 QUADRICEPS TENDON WITH BONE GRAFT
Quadriceps tendon with bone will be used as graft for the surgery.
Intervention: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT (Procedure)
Arm 1 QUADRICEPS TENDON WITH BONE GRAFT
Quadriceps tendon with bone will be used as graft for the surgery.
Intervention: Rehabilitation protocol (Other)
Arm 2 HAMSTRING TENDON GRAFT
Hamstring tendon with bone will be used as graft for the surgery
Intervention: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT (Procedure)
Arm 2 HAMSTRING TENDON GRAFT
Hamstring tendon with bone will be used as graft for the surgery
Intervention: Rehabilitation protocol (Other)
Outcomes
Primary Outcomes
change of Isokinetic strenght test
Time Frame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
the assessment will be made with GENU 3 dynamometer (GENU 3, Easytech, Firenze, Italy), using isokinetic parameters at angular velocities of 60°/sec (3 repetitions), 180°/sec (5 repetitions) and 300°/sec (15 repetitions) with 30 seconds of rest among these. To determine the height of the chair, the lateral femoral condyle was aligned with the rotational axis of the dynamometer. The peak torque, average torque and flexor-extensor torque rate value. Patients will be warm up in a cycle ergometer previously (5 min) and them performing mobilization exercises and stretching in lower limbs (5 min).
Secondary Outcomes
- MUSCLE ARQUITECTURE(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
- Single-legged hop test(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
- Pressure Pain Thresholds(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
- Visual Analogical Scale(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
- ANTEROPOSTERIOR LAXITY(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
- Tegner questionnaire(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
Investigators
Carolina Fernández Lao
Principal Investigator
Universidad de Granada