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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
grade A+ knee mobilization
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee mobilazation, TKA, joint replacement, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • humans >18 years old
  • undergoing TKA per osteoarthritis

Exclusion Criteria:

  • 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

Sites / Locations

  • CHUV

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

grade A+ knee mobilization

Arm Description

Patients receiving the standard rehabilitation protocol

Patients receiving the standard rehabilitation protocol plus grade A+ knee mobilization

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain
pain at rest using a visual analog scale

Full Information

First Posted
March 28, 2014
Last Updated
April 2, 2014
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02105857
Brief Title
The Effects of End-of-range Grade A+ Mobilization Following Acute Primary TKA
Official Title
The Effects of End-of-range Grade A+ Mobilization Following Acute Primary TKA
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
knee mobilazation, TKA, joint replacement, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients receiving the standard rehabilitation protocol
Arm Title
grade A+ knee mobilization
Arm Type
Experimental
Arm Description
Patients receiving the standard rehabilitation protocol plus grade A+ knee mobilization
Intervention Type
Other
Intervention Name(s)
grade A+ knee mobilization
Intervention Description
grade A+ knee mobilization using the joint active systems knee device, 20minutes twice a day in knee extension and knee flexion
Primary Outcome Measure Information:
Title
Range of Motion
Description
Knee passive and active range of motion in flexion and extension using standard goniometry
Time Frame
From the day before surgery untill the 7th postoperative day
Secondary Outcome Measure Information:
Title
Pain
Description
pain at rest using a visual analog scale
Time Frame
From de preoperative day to the seventh day after surgery
Other Pre-specified Outcome Measures:
Title
Patients' destination after discharge
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: humans >18 years old undergoing TKA per osteoarthritis Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luís C Pereira, MSc
Organizational Affiliation
CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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

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