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Clinical Trials/NCT01821599
NCT01821599
Completed
N/A

Comparative Study Between Two Physiotherapy Protocols Conventional X Accelerated in Individuals Undergoing Reconstruction of the Anterior Cruciate Ligament.

University of Sao Paulo1 site in 1 country29 target enrollmentJanuary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rehabilitation
Sponsor
University of Sao Paulo
Enrollment
29
Locations
1
Primary Endpoint
KT1000 measures
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The accelerated rehabilitation and early return does not seem to be harmful, but still needs further research to define the rehabilitation time is what shows Kruse and collaborators (2012) in their study of systematic review. The surgical treatment of anterior cruciate ligament injury is the gold standard in the treatment of these injuries in young and active, the postoperative rehabilitation is extensive and full return to sport occurs only after 6 months postoperatively. Based on this gap, the investigators seek to draw properly through our study methods and more complex techniques, that comparing two rehabilitation programs can achieve high precision early rehabilitation. This will include 32 athletes who had complete ACL rupture confirmed by MRI and underwent ACL reconstruction using patellar tendon.All subjects will be followed from the pre-surgery, the fourth and sixth month after surgery with: KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Isokinetic Muscle Strength (Cybex). Through a random draw of sealed envelopes, patients will be allocated in their rehabilitation groups: Accelerated (4 months) or Conventional (6 months). Preoperatively, fourth and sixth month after surgery will be an assessment of laxity by (KT1000), Muscular Strength (CYBEX) and knee function affected by IKDC (2000) and Hop Test. The assessor and the patients were blinded to treatment group. This study will have the locus Institute of Orthopaedics and Traumatology, School of Medicine, São Paulo. The comparative results of the two groups are analyzed using specific statistical tests to prove an improved significative without damaging the integrity of the graft.

Detailed Description

All subjects will be followed for a period of six months. During this period will undergo three stages of evaluation. 1. º Preoperative up to two years following injury : assessment will consist KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Hop Test (jumps with one leg); Isokinetic Muscle Strength (Cybex). 2. º 4º months pós-surgery KT1000, International Knee Documentation Committee (IKDC 2000); Hop Test; Isokinetic Muscle Strength (Cybex) 3. º 6º months postoperatively KT1000, International Knee Documentation Committee (IKDC) + Hop Test; Isokinetic Muscle Strength (Cybex)

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
April 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

José Carlos Alves Fabrício Júnior

Specialist, Master Student

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • With diagnosis of injury (primary) anterior cruciate ligament confirmed by magnetic resonance may or may not be associated with a meniscal injury or partial ligament medial collateral ligament (MCL) surgery is not indicated.
  • Patients undergo surgery for anterior cruciate ligament reconstruction using patellar tendon.

Exclusion Criteria

  • Patients who had changes in diagnosis during surgery.
  • Surgical complications
  • Patients with More than 30% of lack or abandon physiotherapy.

Outcomes

Primary Outcomes

KT1000 measures

Time Frame: Sixth months

Measure of anterior knee stability

Secondary Outcomes

  • International Knee Documentation Committee (IKDC 2000)(Sixth months)
  • Hop Test measures(sixth months)
  • Isokinetic of the knee measures(sixth months)

Study Sites (1)

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