Rehabilitation Protocol for Reconstruction of Anterior Cruciate Ligament and Anterolateral Knee Ligament Surgery

Rehabilitation Clinical Trial

Official title:

Post-operative Rehabilitation Protocol for Combined Reconstruction of Anterior Cruciate Ligament and Anterolateral Knee Ligament Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03505359
• Other study ID #: 54541116.8.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: December 28, 2019

Study information

• Verified date: May 2018
• Source: University of Sao Paulo General Hospital
• Contact: Silvia M João, PhD
• Phone: 55 11 30918424
• Email: smaj[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 28, 2019
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction
• Anterolateral Ligament Reconstruction
• Rehabilitation

Intervention

Other:
• partial knee immobilization protocol
12 weeks rehabilitation protocol including exercises to improve range of motion, gait, balance, muscle strength with a 0-60 degrees articulated knee brace in the first 6 weeks in the experimental group.
• standard ACL reconstruction rehabilitation protocol
12 weeks rehabilitation protocol including exercises to improve range of motion, gait, balance, muscle strength.

Locations

Country	Name	City	State
Brazil	USaoPauloGH	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Function	Lysholm Knee Scoring Scale: instrument consisting of eight domains: limping, support, re-straining, instability, pain, swelling, climbing stairs and squatting, with closed-answers alternatives. The final result is expressed in nominal and ordinal form, being "excellent" ranging from 95 to 100 points; "Good" from 84 to 94 points; "Regular" between 65 and 83 and "bad" when values are equal to or less than 64.	12 months
Secondary	Follow-up of knee function	Lysholm Knee Scoring Scale: instrument consisting of eight domains: limping, support, re-straining, instability, pain, swelling, climbing stairs and squatting, with closed-answers alternatives. The final result is expressed in nominal and ordinal form, being "excellent" ranging from 95 to 100 points; "Good" from 84 to 94 points; "Regular" between 65 and 83 and "bad" when values are equal to or less than 64.	3 weeks; 6 weeks; 12 weeks; 6 months
Secondary	Static Postural Control	Static Postural Control will be assessed through the AccuSuway mobile power platform.(AMTI®).	3 weeks; 6 weeks; 12 weeks; 6 months and 12 months
Secondary	Dynamic Postural Control	Dynamic Postural Control will be assessed through the Balance Master System (BMS) platform.	3 weeks; 6 weeks; 12 weeks; 6 months and 12 months
Secondary	Muscle strength	The isometric and isokinetic strength test will be performed by an isokinetic dynamometry (Biodex Multi-Joint System III), used to record the torque of the knee flexor and extensor muscles, as well as the hip abductors.	3 weeks; 6 weeks; 12 weeks; 6 months and 12 months