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

Early Mobilization of Knee Joint After ACL Reconstructive Surgery Comparing 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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: Device: CPM; Other: Manual mobilization

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • Althaia Xarxa Assistencial Universitària de Manresa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: CPM; 15 repetitions of flexo-extensión with a commercially available CPM device (Kinetec Advanced Prima); Other: Manual mobilization; Manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist
Active Comparator: 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.	Device: CPM; 15 repetitions of flexo-extensión with a commercially available CPM device (Kinetec Advanced Prima); Other: Manual mobilization; Manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain reported by the patient according to Visual Analogic Scale	Fifteen hours after surgery
Fluid volumen drained (ml)	Fluid volume drained during procedure (ml)	Fifteen hours after surgery
Time (seconds)	Overall time spent in manual mobilization and CPM mobilization	Fifteen hours after surgery

Collaborators and Investigators

• Sponsor: Jesús Montesinos Muñoz
• Collaborators: Fundació Eurecat
• Investigators: Principal Investigator: Jesús Montesinos, MD, ALTHAIA Xarxa Assistencial de Manresa

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Rehabilitation; Anterior Cruciate Ligament Reconstruction; Range of Motion, Articular; Continous Passive Motion; Manual Physical Therapy; Kaltenborn Manual Therapy
• Other Study ID Numbers: CEIC 13/106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided