Anterior Cruciate Ligament ReconstructionNCT02748759
Early Mobilization of Knee Joint After ACL Surgery. Continuous Passive Motion Versus Manual Passive Mobilization
A study testing CPM and Manual mobilization in people with Anterior Cruciate Ligament Reconstruction, run by Jesús Montesinos Muñoz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- CPM and Manual mobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Rupture of Anterior cruciate ligament
- Ligamentoplasty with partial meniscectomy when necessary using arthroscopy technique
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243
About this study
Official title: 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.
Read more
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.
- Being tested
- CPM, Manual mobilization
- Keywords
- Continous Passive Motion, Manual Physical Therapy, Range of Motion, Articular, Anterior Cruciate Ligament Reconstruction, Rehabilitation, Kaltenborn Manual Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPMDevice
15 repetitions of flexo-extensión with a commercially available CPM device (Kinetec Advanced Prima)
Manual mobilizationOther
Manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: CPM; Other: Manual mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Fifteen hours after surgery
Secondary outcomes (3)
Pain
Pain reported by the patient according to Visual Analogic Scale
Measured: Fifteen hours after surgery
Fluid volumen drained (ml)
Fluid volume drained during procedure (ml)
Measured: Fifteen hours after surgery
Time (seconds)
Overall time spent in manual mobilization and CPM mobilization
Measured: Fifteen hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jesús Montesinos Muñoz
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Eurecat
- Responsible party
- Sponsor-investigator, Jesús Montesinos Muñoz, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Jesús Montesinos, MD, Principal investigator, Althaia Xarxa Assistencial de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748759
- Sponsor's protocol ID
- CEIC 13/106
- Status last verified
- Apr 2016
- First submitted
- 15 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilization of Knee Joint After ACL Reconstructive Surgery Comparing Continuous Passive Motion Versus Manual Passive Mobilization
- ClinicalTrials.gov ID
- NCT02748759
- Acronym / sponsor ID
- CEIC 13/106
- Keywords
- Continous Passive Motion, Manual Physical Therapy, Range of Motion, Articular, Anterior Cruciate Ligament Reconstruction, Rehabilitation, Kaltenborn Manual Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jesús Montesinos MuñozUniversity, hospital or other
- Collaborators
- Fundació Eurecat
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXP 1: Manual mobilization / CPM | Active comparator | Device: CPM, Other: Manual mobilizationPatients 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 | Active comparator | Device: CPM, Other: Manual mobilizationPatients 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Rupture of Anterior cruciate ligament
- Ligamentoplasty with partial meniscectomy when necessary using arthroscopy technique
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPM15 repetitions of flexo-extensión with a commercially available CPM device (Kinetec Advanced Prima) | Device | EXP 1: Manual mobilization / CPM, EXP 2: CPM / Manual mobilization |
| Manual mobilizationManual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist | Other | EXP 1: Manual mobilization / CPM, EXP 2: CPM / Manual mobilization |
Primary outcome
Knee Range of Motion (ROM) angle
Time frame: 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
Time frame: 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
Time frame: Fifteen hours after surgery
Maximum knee extension obtained form 15 repetitions of flexo-extensión. Measurements were obtained by CPM device and an external goniometer
3 secondary outcomes
Pain
Time frame: Fifteen hours after surgery
Fluid volumen drained (ml)
Time frame: Fifteen hours after surgery
Time (seconds)
Time frame: Fifteen hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús Montesinos, MD principal investigator
Althaia Xarxa Assistencial de Manresa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPM and Manual mobilization in people with Anterior Cruciate Ligament Reconstruction, run by Jesús Montesinos Muñoz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Range of Motion (ROM) angle (time frame: Fifteen hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.