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

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

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.

Study Overview

• Status: Unknown
• Conditions: Anterior Cruciate Ligament Reconstruction; Rehabilitation; Anterolateral Ligament Reconstruction
• Intervention / Treatment: Other: partial knee immobilization protocol; Other: standard ACL reconstruction rehabilitation protocol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Recruiting
    • USaoPauloGH
    • Contact: Silvia M João, PhD; Phone Number: 55 11 3091-8424; Email: smaj@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Group treated by the new protocol with partial knee immobilization	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.
Active Comparator: Control group; Group treated by a standard protocol for ACL reconstruction.	Other: standard ACL reconstruction rehabilitation protocol; 12 weeks rehabilitation protocol including exercises to improve range of motion, gait, balance, muscle strength.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Silvia M João, PhD, University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): December 28, 2019
• Study Completion (Anticipated): December 28, 2019

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 54541116.8.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is not a plan to make IPD available until the protocol is published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No