Hôpital Jean-Talon
Montreal, Quebec, H2E 1S6, Canada
Completed
NCT Number: NCT02928835
Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Knee flexion Dynasplint orthosis
DeviceStandardized 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.
Other names: Dynasplint
Primary outcomes
-
The knee flexion angle was assessed in supine position with a universal goniometer
Time frame: Change from baseline knee flexion angle at 6 months
The outcomes were obtained by one experienced and well-trained physical therapist.
Secondary outcomes
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Measures of knee function.
Time frame: Change from baseline knee flexion angle at 6 months
Assessed by the Knee Society Score (KSS)
-
Measures for quality of life
Time frame: Change from baseline knee flexion angle at 6 months
Assessed by Short-form 36 Health Survey (SF-36)
Sponsors and collaborators
Lead sponsor
Universidade Norte do Paraná
Other
Collaborators
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2013
- First posted
- Oct 10, 2016
- Registry last updated
- Oct 10, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.