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

NCT02748759 | Completed

• 1 other identifier: CEIC 13/106
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Continous Passive Motion; Manual Physical Therapy; Range of Motion, Articular; Anterior Cruciate Ligament Reconstruction; Rehabilitation; Kaltenborn Manual Therapy

Outcome Measures

Primary Outcomes (3)

• Knee Range of Motion (ROM) angle

  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

  Fifteen hours after surgery

• Knee maximum flexion

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

  Fifteen hours after surgery

• Knee maximum extension

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

  Fifteen hours after surgery

Secondary Outcomes (3)

• Pain

  Fifteen hours after surgery

• Fluid volumen drained (ml)

  Fifteen hours after surgery

• Time (seconds)

  Fifteen hours after surgery

Study Arms (2)

EXP 1: Manual mobilization / CPM

ACTIVE COMPARATOR

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.

Device: CPM; Other: Manual mobilization

EXP 2: CPM / Manual mobilization

ACTIVE COMPARATOR

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.

Device: CPM; Other: Manual mobilization

Interventions

CPM DEVICE

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

EXP 1: Manual mobilization / CPM; EXP 2: CPM / Manual mobilization

Manual mobilization OTHER

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

EXP 1: Manual mobilization / CPM; EXP 2: CPM / Manual mobilization

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jesús Montesinos Muñoz: lead
• Fundació Eurecat: collaborator

Study Sites (1)

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

Location

Study Officials

• Jesús Montesinos, MD

  Althaia Xarxa Assistencial de Manresa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 22, 2016
• Study Start: May 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

ES (1)