Clinical trial NCT02748759: Early Mobilization of Knee Joint After ACL Surgery. Continuous Passive Motion Versus Manual Passive Mobilization
Official title: Early Mobilization of Knee Joint After ACL Reconstructive Surgery Comparing Continuous Passive Motion Versus Manual Passive Mobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Continous Passive Motion
Manual Physical Therapy
Range of Motion, Articular
Anterior Cruciate Ligament Reconstruction
Rehabilitation
Kaltenborn Manual Therapy
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
Collaborators: name: Fundació Eurecat
First posted: 2016-04-22
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Knee Range of Motion (ROM) angle
timeFrame: Fifteen hours after surgery
measure: Knee maximum flexion
timeFrame: Fifteen hours after surgery
measure: Knee maximum extension
timeFrame: Fifteen hours after surgery
Secondary outcomes:
measure: Pain
timeFrame: Fifteen hours after surgery
measure: Fluid volumen drained (ml)
timeFrame: Fifteen hours after surgery
measure: Time (seconds)
timeFrame: Fifteen hours after surgery
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial Universitària de Manresa
state: Barcelona
Study officials:
affiliation: Althaia Xarxa Assistencial de Manresa
name: Jesús Montesinos, MD
role: PRINCIPAL_INVESTIGATOR
References: