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

NCT ID: NCT03505359

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2019-12-28

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Reconstruction Anterolateral Ligament Reconstruction Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Experimental group

Group treated by the new protocol with partial knee immobilization

Group Type EXPERIMENTAL

partial knee immobilization protocol

Intervention Type OTHER

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.

Control group

Group treated by a standard protocol for ACL reconstruction.

Group Type ACTIVE_COMPARATOR

standard ACL reconstruction rehabilitation protocol

Intervention Type OTHER

12 weeks rehabilitation protocol including exercises to improve range of motion, gait, balance, muscle strength.

Interventions

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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.

Intervention Type OTHER

standard ACL reconstruction rehabilitation protocol

12 weeks rehabilitation protocol including exercises to improve range of motion, gait, balance, muscle strength.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Silvia Maria Amado João

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Silvia M João, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

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USaoPauloGH

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Silvia M João, PhD

Role: CONTACT

55 11 30918424

Juliana f Sauer, Master

Role: CONTACT

55 11 30918424

Facility Contacts

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Silvia M João, PhD

Role: primary

55 11 3091-8424

Other Identifiers

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54541116.8.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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