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OpenTrials
Completed

NCT Number: NCT02748759

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPM

Device

15 repetitions of flexo-extensión with a commercially available CPM device (Kinetec Advanced Prima)

Manual mobilization

Other

Manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Pain

    Time frame: Fifteen hours after surgery

    Pain reported by the patient according to Visual Analogic Scale

  2. Fluid volumen drained (ml)

    Time frame: Fifteen hours after surgery

    Fluid volume drained during procedure (ml)

  3. Time (seconds)

    Time frame: Fifteen hours after surgery

    Overall time spent in manual mobilization and CPM mobilization

Sponsors and collaborators

Lead sponsor

Jesús Montesinos Muñoz

Other

Collaborators

  • Fundació Eurecat

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2016
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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