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

NCT ID: NCT02748759

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-11-30

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EXP 1: Manual mobilization / CPM

Patients were subjected to a manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist. After a pause of 5 minutes, the patient was collocated in a commercially available CPM device (Kinetec Advanced Prima) and received 15 repetitions of flexo-extension.

Group Type: ACTIVE_COMPARATOR

CPM

Intervention Type: DEVICE

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

Manual mobilization

Intervention Type: OTHER

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

EXP 2: CPM / Manual mobilization

Patients were collocated in a commercially available CPM device (Kinetec Advanced Prima) and received 15 repetitions of flexo-extension. After a pause of 5 minutes, patients were subjected to a manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist.

Group Type: ACTIVE_COMPARATOR

CPM

Intervention Type: DEVICE

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

Manual mobilization

Intervention Type: OTHER

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

Interventions

CPM

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

Intervention Type: DEVICE

Manual mobilization

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Eurecat

OTHER

Sponsor Role: collaborator

Jesús Montesinos Muñoz

OTHER

Sponsor Role: lead

Responsible Party

Jesús Montesinos Muñoz

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jesús Montesinos, MD

Role: PRINCIPAL_INVESTIGATOR

Althaia Xarxa Assistencial de Manresa

Locations

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, Spain

Countries

Spain

Other Identifiers

CEIC 13/106

Identifier Type: -

Identifier Source: org_study_id