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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03505359
Enrollment
28
Registered
2018-04-23
Start date
2016-11-01
Completion date
2019-12-28
Last updated
2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction, Anterolateral Ligament Reconstruction, Rehabilitation

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.

Interventions

OTHERpartial 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.

OTHERstandard ACL reconstruction rehabilitation protocol

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

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

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.

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Knee Function12 monthsLysholm 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

MeasureTime frameDescription
Follow-up of knee function3 weeks; 6 weeks; 12 weeks; 6 monthsLysholm 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.
Static Postural Control3 weeks; 6 weeks; 12 weeks; 6 months and 12 monthsStatic Postural Control will be assessed through the AccuSuway mobile power platform.(AMTI®).
Dynamic Postural Control3 weeks; 6 weeks; 12 weeks; 6 months and 12 monthsDynamic Postural Control will be assessed through the Balance Master System (BMS) platform.
Muscle strength3 weeks; 6 weeks; 12 weeks; 6 months and 12 monthsThe 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.

Countries

Brazil

Contacts

Primary ContactSilvia M João, PhD
smaj@usp.br55 11 30918424
Backup ContactJuliana f Sauer, Master
juliana.sauer@usp.br55 11 30918424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026