Orthopedic Surgery Clinical Trial
— PTGMassOfficial title:
Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement
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 |
Verified date | February 2017 |
Source | University Hospital, Limoges |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | University Hospital, Limoges | Limoges |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges |
France,
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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