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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02748759
Enrollment
15
Registered
2016-04-22
Start date
2014-05-31
Completion date
2015-11-30
Last updated
2016-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

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

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.

Interventions

DEVICECPM

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

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

Sponsors

Fundació Eurecat
CollaboratorOTHER
Jesús Montesinos Muñoz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Knee Range of Motion (ROM) angleFifteen hours after surgeryMaximum 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 flexionFifteen hours after surgeryMaximum knee flexion obtained form 15 repetitions of flexo-extensión. Measurements were obtained by CPM device and an external goniometer
Knee maximum extensionFifteen hours after surgeryMaximum knee extension obtained form 15 repetitions of flexo-extensión. Measurements were obtained by CPM device and an external goniometer

Secondary

MeasureTime frameDescription
Time (seconds)Fifteen hours after surgeryOverall time spent in manual mobilization and CPM mobilization
PainFifteen hours after surgeryPain reported by the patient according to Visual Analogic Scale
Fluid volumen drained (ml)Fifteen hours after surgeryFluid volume drained during procedure (ml)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026