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Clinical Trials/NCT02748759
NCT02748759
Completed
Not Applicable

Early Mobilization of Knee Joint After ACL Reconstructive Surgery Comparing Continuous Passive Motion Versus Manual Passive Mobilization

Jesús Montesinos Muñoz1 site in 1 country15 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Reconstruction
Sponsor
Jesús Montesinos Muñoz
Enrollment
15
Locations
1
Primary Endpoint
Knee Range of Motion (ROM) angle
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Anterior Cruciate Ligament (ACL) injuries by trauma are a prevalent pathology. In the USA, about 200.000 injuries are estimated per year, half of which implicate a total rupture of the ligament. Data indicates that the number of ACL injuries is increasing in young athletes and presents a common problem, especially people playing agility sports.

One of the most widely used methods for the post-surgical mobilization after ACL is the use of Continuous Passive Motion (CPM) devices. These machines are meant to drain residual fluid from the articulation and maintain the mobility of the joint and muscles in the knee. Even though studies show that, an early mobilization after surgery is beneficial to the rehabilitation of the knee joint, recent studies are questioning the efficiency of the CPM when compared with the goal of application. While literature suggests that efficacy of CPM are related with the magnitude of knee flexion and the Range of Motion (ROM) achieved some studies show that the range of motion measured by the CPM is considerably less than the actual ROM.

As other therapy that provides an effective mobilization of the knee joint, the Specific Manual Physical Therapy method (Kaltenborn method) takes in account the physiological combination of rotation and gliding of the two joint surfaces. This technique mobilizes the femorotibial joint by controlling the tibial plateau anteroposterior during flexion and posteroanterior during extension of the knee. Therefore, in the past 30 years there are not studies comparing ROM measurements obtained with CPM and manual physical therapy methods.

It is hypothesized that the benefits of the early passive mobilization after ACL reconstructive surgery are diminished by the limited efficacy of currently used CPM devices. The aim of our study was to determine the range of motion achieved with the passive mobilization using a CPM device compared with a manual method (Kaltenborn method) and to assess that ROM measurements provided by the CPM correlates the real ROM.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
November 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Jesús Montesinos Muñoz
Responsible Party
Sponsor Investigator
Principal Investigator

Jesús Montesinos Muñoz

Medical Doctor

Althaia Xarxa Assistencial Universitària de Manresa

Eligibility Criteria

Inclusion Criteria

  • Rupture of Anterior cruciate ligament
  • Ligamentoplasty with partial meniscectomy when necessary using arthroscopy technique

Exclusion Criteria

  • Patients operated after three weeks post-injury because of greater risk of arthrofibrosis
  • Patients who had medical complications during surgery
  • Patients unable to understand the study protocol and those unwilling to give informed consent

Outcomes

Primary Outcomes

Knee Range of Motion (ROM) angle

Time Frame: Fifteen hours after surgery

Maximum knee flexion angle minus the maximum knee extension angle obtained from 15 repetitions of flexo-extension. Measurements were obtained by CPM device and an external goniometer

Knee maximum flexion

Time Frame: Fifteen hours after surgery

Maximum knee flexion obtained form 15 repetitions of flexo-extensión. Measurements were obtained by CPM device and an external goniometer

Knee maximum extension

Time Frame: Fifteen hours after surgery

Maximum knee extension obtained form 15 repetitions of flexo-extensión. Measurements were obtained by CPM device and an external goniometer

Secondary Outcomes

  • Pain(Fifteen hours after surgery)
  • Fluid volumen drained (ml)(Fifteen hours after surgery)
  • Time (seconds)(Fifteen hours after surgery)

Study Sites (1)

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