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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Device: CPM; Other: Manual mobilization

• Registration Number: NCT02748759
• Lead Sponsor: Jesús Montesinos Muñoz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-04
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-22
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EXP 1: Manual mobilization / CPM	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.
EXP 1: Manual mobilization / CPM	Manual mobilization	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.
EXP 2: CPM / Manual mobilization	CPM	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.
EXP 2: CPM / Manual mobilization	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.

Primary Outcome Measures

Name	Time	Method
Knee Range of Motion (ROM) angle	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	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Althaia Xarxa Assistencial Universitària de Manresa; 🇪🇸 Manresa, Barcelona, Spain