NCT03505359

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

3.2 years

First QC Date

October 3, 2017

Last Update Submit

May 3, 2018

Conditions

Anterior Cruciate Ligament ReconstructionAnterolateral Ligament ReconstructionRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Follow-up of knee function

    3 weeks; 6 weeks; 12 weeks; 6 months

  • Static Postural Control

    3 weeks; 6 weeks; 12 weeks; 6 months and 12 months

  • Dynamic Postural Control

    3 weeks; 6 weeks; 12 weeks; 6 months and 12 months

  • Muscle strength

    3 weeks; 6 weeks; 12 weeks; 6 months and 12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Group treated by the new protocol with partial knee immobilization

Other: partial knee immobilization protocol

Control group

ACTIVE COMPARATOR

Group treated by a standard protocol for ACL reconstruction.

Other: standard ACL reconstruction rehabilitation protocol

Interventions

partial knee immobilization protocolOTHER

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.

Experimental group
standard ACL reconstruction rehabilitation protocolOTHER

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

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male individuals will be selected to avoid physiological differences between genders, such as muscle strength, flexibility and ligamentous laxity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males
  • Aged from 18 to 40 years
  • Documented and symptomatic anterior cruciate ligament (ACL) injury followed by ACL+ anterolateral ligament (ALL) ligament reconstruction

You may not qualify if:

  • Patients with multiple ligament injuries
  • Bilateral ACL injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USaoPauloGH

São Paulo, Brazil

RECRUITING

Study Officials

  • Silvia M João, PhD

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia M João, PhD

CONTACT

55 11 30918424smaj@usp.br

Juliana f Sauer, Master

CONTACT

55 11 30918424juliana.sauer@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2017

First Posted

April 23, 2018

Study Start

November 1, 2016

Primary Completion

December 28, 2019

Study Completion

December 28, 2019

Last Updated

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available until the protocol is published

Locations

BR(1)