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

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ClinicalTrials.gov Identifier: NCT03505359
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Silvia Maria Amado João, University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Anterolateral Ligament Reconstruction Rehabilitation Other: partial knee immobilization protocol Other: standard ACL reconstruction rehabilitation protocol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Post-operative Rehabilitation Protocol for Combined Reconstruction of Anterior Cruciate Ligament and Anterolateral Knee Ligament Surgery
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : December 28, 2019
Estimated Study Completion Date : December 28, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Knee Function [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Follow-up of knee function [ Time Frame: 3 weeks; 6 weeks; 12 weeks; 6 months ]
    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.

  2. Static Postural Control [ Time Frame: 3 weeks; 6 weeks; 12 weeks; 6 months and 12 months ]
    Static Postural Control will be assessed through the AccuSuway mobile power platform.(AMTI®).

  3. Dynamic Postural Control [ Time Frame: 3 weeks; 6 weeks; 12 weeks; 6 months and 12 months ]
    Dynamic Postural Control will be assessed through the Balance Master System (BMS) platform.

  4. Muscle strength [ Time Frame: 3 weeks; 6 weeks; 12 weeks; 6 months and 12 months ]
    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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only male individuals will be selected to avoid physiological differences between genders, such as muscle strength, flexibility and ligamentous laxity.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505359


Contacts
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Contact: Silvia M João, PhD 55 11 30918424 smaj@usp.br
Contact: Juliana f Sauer, Master 55 11 30918424 juliana.sauer@usp.br

Locations
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Brazil
USaoPauloGH Recruiting
São Paulo, Brazil
Contact: Silvia M João, PhD    55 11 3091-8424    smaj@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Silvia M João, PhD University of Sao Paulo General Hospital

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Responsible Party: Silvia Maria Amado João, Principal Investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03505359     History of Changes
Other Study ID Numbers: 54541116.8.0000.0068
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available until the protocol is published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No