Dynamic Splinting After Total Knee Arthroplasty

This study has been terminated.
(Unrelated to trial)
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00857701
First received: March 6, 2009
Last updated: August 8, 2013
Last verified: August 2013

March 6, 2009
August 8, 2013
January 2009
May 2015   (final data collection date for primary outcome measure)
Change in Maximal Acitive Range of Mothion in knee extension [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00857701 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dynamic Splinting After Total Knee Arthroplasty
Dynamic Splinting After Total Knee Arthroplasty: a Randomized, Controlled Trial

The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty.

The purpose of the study is to evaluate the efficacy of dynamic splinting for knee flexion contracture following a total knee arthroplasty.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Reduced Knee Flexion
Device: Knee Extension Dynasplint
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device.
  • No Intervention: 1
    Patient will receive post-surgical standard of care treatment with standard Physical therapy and NSAIDs.
  • Experimental: 2
    Patients will be treated with the Standard of Care physical therapy and NSAIDs as well as a Knee Extension Dynasplint that includes tension chambers.
    Intervention: Device: Knee Extension Dynasplint

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
Not Provided
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Reduced flexibility in AROM of knee extension
  • Pain that is worsened by bending over while legs are straight
  • Impaired gait pattern
  • Ability to understand informed consent and experiment responsibilities

Exclusion Criteria:

  • Fractures
  • Knee sepsis
  • Osteomyelitis or any orthopedic infection
  • Extensor mechanism dysfunction
  • Psoriasis
  • Knee joint neuropathy
  • Previous Stroke or Brain Injury
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00857701
2008.009
Yes
Dynasplint Systems, Inc.
Dynasplint Systems, Inc.
Not Provided
Not Provided
Dynasplint Systems, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP