Clinical trial NCT03505359: Rehabilitation Protocol for Reconstruction of Anterior Cruciate Ligament and Anterolateral Knee Ligament Surgery
Official title: Post-operative Rehabilitation Protocol for Combined Reconstruction of Anterior Cruciate Ligament and Anterolateral Knee Ligament Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Anterolateral Ligament Reconstruction
Rehabilitation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A blinded randomized clinical trial will be conducted to evaluate the effects of two protocols for the rehabilitation of patients undergoing combined re-construction of ACL and ALL.
Primary purpose: TREATMENT

Brief summary: Introduction: Individuals with an ACL lesion present abnormal rotational stability. Among the structures located in the anterolateral region of the knee that could act as restraints of the rotational knee lassitude, there is the Anterior Lateral Ligament (ALL), and its reconstruction associated with ACL reconstruction could reduce recurrence injury rates. Objective: to develop a rehabilitation protocol for patients undergoing combined reconstruction of ACL and ALL. METHOD: Articles published with patients submitted to ACL reconstruction with an anatomic technique and flexor tendon graft, (which is the same one adopted in this study), were selected as a base to this protocol. Discussion: The results will provide important information on clinical practice, since it can help identify the necessity or not of restraining the knee range of motion in combined surgeries. It can guide the therapeutic planning, including the cost of knee restraint devices, in addition to estimating these patients prognosis. The protocol with partial restriction of knee range of motion in the first 6 weeks of postoperative is the most indicated program in the rehabilitation of the combined surgeries of ACL and ALL reconstruction.

Detailed description: Currently, the anatomical reconstruction of the ACL has been widely used, with the purpose of increasing the knee rotational control after the injury, and thus, to improve the clinical evolution in the long term. The concept involves restoring knee kinematics by improving function by reducing the number of graft failures, delaying or preventing degeneration of the joint. Normally, rehabilitation protocols in these cases are more careful with respect to knee ROM gain and use of exercises in open kinetic chain, with the purpose of preserving the graft.

Allied to this concept, the use of extra-articular reconstruction associated with ACL reconstruction, gained new horizons with the discovery of ALL, signaling to the possibility of a better rotational control and, consequently, a decrease in the number of graft failures.

Due to the particularities of each surgical technique, it is necessary that the rehabilitation protocols adapt to the different methods, guaranteeing the functional recovery, but without damages to the reconstruction.

With the proposal of ACL reconstruction surgery associated with ALL reconstruction, it is necessary to develop a specific rehabilitation protocol for these patients, considering some postoperative specificities of extra-articular reconstructions, since they are data that are not available in the literature until now.

Eligibility criteria: Inclusion Criteria:

* Males
* Aged from 18 to 40 years
* Documented and symptomatic anterior cruciate ligament (ACL) injury followed by ACL+ anterolateral ligament (ALL) ligament reconstruction

Exclusion Criteria:

* Patients with multiple ligament injuries
* Bilateral ACL injury

Primary outcomes:
measure: Knee Function
timeFrame: 12 months
Secondary outcomes:
measure: Follow-up of knee function
timeFrame: 3 weeks; 6 weeks; 12 weeks; 6 months
measure: Static Postural Control
timeFrame: 3 weeks; 6 weeks; 12 weeks; 6 months and 12 months
measure: Dynamic Postural Control
timeFrame: 3 weeks; 6 weeks; 12 weeks; 6 months and 12 months
measure: Muscle strength
timeFrame: 3 weeks; 6 weeks; 12 weeks; 6 months and 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: USaoPauloGH
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Silvia M João, PhD
role: PRINCIPAL_INVESTIGATOR
References: