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Dynamic Splinting After Total Knee Arthroplasty

This study has been terminated.
(Unrelated to trial)
Information provided by (Responsible Party):
Dynasplint Systems, Inc. Identifier:
First received: March 6, 2009
Last updated: August 8, 2013
Last verified: August 2013
The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty.

Condition Intervention
Reduced Knee Flexion
Device: Knee Extension Dynasplint

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynamic Splinting After Total Knee Arthroplasty: a Randomized, Controlled Trial

Resource links provided by NLM:

Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:
  • Change in Maximal Acitive Range of Mothion in knee extension [ Time Frame: 9 weeks ]

Enrollment: 25
Study Start Date: January 2009
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00857701

United States, Arizona
Dennis L Armstrong M.D.
Mesa, Arizona, United States, 85206
Sponsors and Collaborators
Dynasplint Systems, Inc.
  More Information


Responsible Party: Dynasplint Systems, Inc. Identifier: NCT00857701     History of Changes
Other Study ID Numbers: 2008.009
Study First Received: March 6, 2009
Last Updated: August 8, 2013

Keywords provided by Dynasplint Systems, Inc.:
total knee arthroplasty
Dynamic Splinting
Knee extension
Reduced knee flexion after total knee arthroscopy processed this record on May 25, 2017