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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02278627
Other study ID # I11002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date December 2017

Study information

Verified date February 2017
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During fthe first postoperative days, physiotherapists supported patients with knee replacement in orthopaedics of Saint-Junien's and Limoges' hospitals. This support includes movements of the leg in active and non active motions, without any help and with an arthromotor, and involves walking rehabilitation.

The investigators would like to complete the physiotherapist's support with manual lymphatic drainage (MLD) using a specific method based on pressure of finger splayed (PFS). This might have a positive impact on time recovery of joint range, on postoperative oedema resorbtion and on patient's pain during rehabilitation classes.

French National Authority for Health specifies there is not a single study assessing massage effects on knee replacement, according to current bibliography.

The investigators purpose is the establishment of a prospective, controlled, randomised trial referred as a "superiority" trial. A total of 98 patients divided in 2 parallel groups will be created.

The study will be in an open-label manner for both patient and physiotherapist involved in walk rehabilitation but will be conducted as a blinded study for the investigating physiotherapist.

Inclusion period will be 17 months and the following period will be 6 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least 18-years-old patients.

- Men and women operated for a knee replacement.

- Patients affiliated to a social security system and having given their informed consent write.

Exclusion Criteria:

- Patients operated on Fridays

- Patients presenting contraindications to the administration of a treatment by héparine

- Patients affected by insane pathology or by confusion.

- Patients participating in another medical research

- Pregnant and breast-feeding women and without effective contraception.

- Patients under guardianship or guardianship.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
manual lymphatic drainage


Locations

Country Name City State
France University Hospital, Limoges Limoges

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To measure the joint range at day 7 after operation The measures will be made with a goniometer 2 days (Day 0 and Day 7)
Secondary To measure the oedema at day 7 after operation 2 days (Day 0 and Day 7)
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