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Osteoarthritis, KneeNCT02105857

The Effects of End-of-range Grade A+ Mobilization Following Acute Primary TKA

A study testing grade A+ knee mobilization in people with Osteoarthritis, Knee, run by University of Lausanne Hospitals at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to find the best way to mobilize a knee after total knee arthroplasty (TKA). In particular, the aim of this study will be to investigate the advantages of adding a gentle knee mobilization to the standard rehabilitation used by physiotherapists in this hospital after TKA. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
grade A+ knee mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSwitzerland
Study dates
Mar 2011to May 2013
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • humans >18 years old
  • undergoing TKA per osteoarthritis

Who cannot join

  • insufficient French language skills to agree a written consent
  • body mass index (BMI) >40 kg/m2
  • symptomatic OA in the contralateral knee (defined as self-reported knee pain >4 on a 10-point verbal analogue scale)
  • other lower extremity orthopedic problems limiting function
  • neurologic impairment
  • cognitive dysfunction

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • CHUV

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

The purpose of the study is to find the best way to mobilize a knee after total knee arthroplasty (TKA). In particular, the aim of this study will be to investigate the advantages of adding a gentle knee mobilization to the standard rehabilitation used by physiotherapists in this hospital after TKA.

All individuals waiting for TKA from the "Departement de l'appareill Locomoteur (DAL) - Centre Hospitalier Universitaire Vaudoise (CHUV)" will be considered for this research trial. The number of individuals necessary to complete this study is 32.

Read more

Participants deciding to take part will be given an information sheet and asked to sign a consent form. If deciding to take part, they will still be free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care they receive.

People who agree to take part will be randomly selected into 2 groups: one group will follow the standard treatment used in physiotherapy after TKA, the other group will have the same treatment and the technique of A+ mobilization in investigation added. Participants have 50% chances to be allocated to either of the groups. Before surgery, at the first and seventh day after operation, the researchers will measure the range of motion (ROM) of the replaced knee. This means that the study will last till the moment the last participant leaves the DAL - CHUV, which is estimated to be in 12 months after the first recruitment.

Individuals over 18 years old undergoing unilateral primary TKA caused by osteoarthritis will included. Exclusion criteria will be: a) insufficient French language skills to agree a written consent, b) body mass index (BMI) >40 kg/m2, c) symptomatic OA in the contralateral knee (defined as self-reported knee pain >4 on a 10-point verbal analogue scale), d) other lower extremity orthopedic problems limiting function, e) neurologic impairment or g) cognitive dysfunction.

No life-style restrictions will be requested. Patients will just need to follow the physiotherapist's usual advices during the in-hospital period at the DAL - CHUV. This study does not alter the standard procedures, patients will receive all the techniques used in physiotherapy as every other TKA patient. If allocated into the mobilization group, a specific knee splint will be positioned on the patient's knee. This position will be held for 20 minutes with the leg straight and 20 minutes bent, twice a day. The person in charge of these procedures is the principal investigator of the study, a certified orthopedic physiotherapist on the staff of the DAL - CHUV. No additional changes to patients' daily routine will be involved.

To the investigators knowledge, there are no side effects due to use of this mobilization. Nevertheless, the pain levels of every patient will be recorded to identify any differences between groups. If, during or after the clinical study, any patient will face unexpected health problems related with the study, they will be kindly asked to transmit the information to the principal investigator of the study. The mobilization technique involves no additional risk over that of standard treatment performed in the hospital. This study hypothesis that adding A+ graded mobilization combined with the standard in-hospital rehabilitation protocol will improve ROM without increasing pain.

All information collected will be kept strictly confidential. Any information used will have names and addresses removed. All data will be stored, analyzed and reported in compliance with the Data Protection Legislation of Switzerland.

Being tested
grade A+ knee mobilization
Keywords
knee mobilazation, TKA, joint replacement, rehabilitation
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • grade A+ knee mobilizationOther

    grade A+ knee mobilization using the joint active systems knee device, 20minutes twice a day in knee extension and knee flexion

Study groups in NCT02105857
Study groupRoleWhat they receive
Standard careNo interventionPatients receiving the standard rehabilitation protocol
grade A+ knee mobilizationExperimentalPatients receiving the standard rehabilitation protocol plus grade A+ knee mobilization
Receives: Other: grade A+ knee mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Range of Motion

    Knee passive and active range of motion in flexion and extension using standard goniometry

    Measured: From the day before surgery untill the 7th postoperative day

Secondary outcomes (1)
  1. Pain

    pain at rest using a visual analog scale

    Measured: From de preoperative day to the seventh day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2014 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2012
  4. Study completionMay 2013

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02105857
Sponsor's protocol ID
ULausanneH
Status last verified
Apr 2014
First submitted
28 Mar 2014
Last updated
7 Apr 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing grade A+ knee mobilization in people with Osteoarthritis, Knee, run by University of Lausanne Hospitals at 1 site in Switzerland.

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 6 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 7 Apr 2014. 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 Switzerland. 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?

Range of Motion (time frame: From the day before surgery untill the 7th postoperative day). 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 7 Apr 2014.

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