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Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial

Primary Purpose

Acquired Fixed Flexion Deformity of the Knee (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Knee flexion Dynasplint orthosis
Sponsored by
Universidade Norte do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acquired Fixed Flexion Deformity of the Knee (Disorder) focused on measuring Total knee arthroplasty, Knee flexion, Dynamic orthosis

Eligibility Criteria

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

Inclusion Criteria:

Patients enrolled will have been schedule to receive first prosthesis of the knee:

Arthritis of the knee, dominated with pain Painful, deformed, and/or unstable knees secondary to degenerative or inflammatory conditions

Exclusion Criteria:

Fractures Knee sepsis Osteomyelitis or any orthopedic infection Psoriasis Knee joint neuropathy Previous Stroke or Brain Injury Significant pathology acquired secondary to the surgery

Sites / Locations

  • Hôpital Jean-Talon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dynasplint group

Control group

Arm Description

The experimental group received standardized physical therapy intervention and used the knee flexion Dynasplint orthosis six hours daily during one month, starting at day seven after total knee arthroplasty surgery.

Control group received standardized physical therapy intervention.

Outcomes

Primary Outcome Measures

The knee flexion angle was assessed in supine position with a universal goniometer
The outcomes were obtained by one experienced and well-trained physical therapist.

Secondary Outcome Measures

Measures of knee function.
Assessed by the Knee Society Score (KSS)
Measures for quality of life
Assessed by Short-form 36 Health Survey (SF-36)

Full Information

First Posted
October 6, 2016
Last Updated
October 6, 2016
Sponsor
Universidade Norte do Paraná
Collaborators
Hopital du Sacre-Coeur de Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT02928835
Brief Title
Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial
Official Title
Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Norte do Paraná
Collaborators
Hopital du Sacre-Coeur de Montreal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effects of a knee flexion Dynasplint orthosis on knee flexion angle after a total knee arthroplasty. Sixty participants, who underwent a total knee arthroplasty, were randomly assigned in two groups: control group and Dynasplint group.
Detailed Description
Post-surgical rehabilitation interventions following total knee arthroplasty consist mainly of stretching exercises to improve flexibility and prevent soft tissue fibroses around the joint, thus, avoiding contractures and providing increases in the range of motion at the knee joint. Although knee manipulation and open arthrolysis may improve range of motion after total knee arthroplasty , the results have been variable and additional procedures are frequently necessary. Studies demonstrated the effectiveness of dynamic orthoses in reducing joint contractures after orthopedic surgeries in various joints that require a long rehabilitation period. Therefore, the purpose of the present study was to evaluate the effects of the knee flexion Dynasplint orthosis (KFD) on the length of rehabilitation and range of knee flexion angle after total knee arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Fixed Flexion Deformity of the Knee (Disorder)
Keywords
Total knee arthroplasty, Knee flexion, Dynamic orthosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynasplint group
Arm Type
Experimental
Arm Description
The experimental group received standardized physical therapy intervention and used the knee flexion Dynasplint orthosis six hours daily during one month, starting at day seven after total knee arthroplasty surgery.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group received standardized physical therapy intervention.
Intervention Type
Device
Intervention Name(s)
Knee flexion Dynasplint orthosis
Other Intervention Name(s)
Dynasplint
Intervention Description
Standardized rehabilitation procedures started at the first day after total knee arthroplasty. Both groups received the same standardized physical therapy intervention. The experimental group used the knee flexion Dynasplint orthosis (Dynasplint Systems, Inc. Canada, Woodbridge, ON) at night, while sleeping, over six continuous hours for one month, starting seven days after the total knee arthroplasty. The control group received only the standardized physical therapy intervention.
Primary Outcome Measure Information:
Title
The knee flexion angle was assessed in supine position with a universal goniometer
Description
The outcomes were obtained by one experienced and well-trained physical therapist.
Time Frame
Change from baseline knee flexion angle at 6 months
Secondary Outcome Measure Information:
Title
Measures of knee function.
Description
Assessed by the Knee Society Score (KSS)
Time Frame
Change from baseline knee flexion angle at 6 months
Title
Measures for quality of life
Description
Assessed by Short-form 36 Health Survey (SF-36)
Time Frame
Change from baseline knee flexion angle at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients enrolled will have been schedule to receive first prosthesis of the knee: Arthritis of the knee, dominated with pain Painful, deformed, and/or unstable knees secondary to degenerative or inflammatory conditions Exclusion Criteria: Fractures Knee sepsis Osteomyelitis or any orthopedic infection Psoriasis Knee joint neuropathy Previous Stroke or Brain Injury Significant pathology acquired secondary to the surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eros De Oliveira Jr, PhD
Organizational Affiliation
Universidade Norte do Paraná
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Jean-Talon
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2E 1S6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8512680
Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial

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