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Dynamic Splinting After Total Knee Arthroplasty

This study has been terminated.
(Unrelated to trial)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857701
First Posted: March 9, 2009
Last Update Posted: August 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
  Purpose
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: None (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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857701


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

Publications:
Denis M, Moffet H, Caron F, Ouellet D, Paquet J, Nolet L. Effectiveness of continuous passive motion and conventional physical therapy after total knee arthroplasty: a randomized clinical trial. Phys Ther. 2006 Feb;86(2):174-85.
Scuderi GR, Kochhar T. Management of flexion contracture in total knee arthroplasty. J Arthroplasty. 2007 Jun;22(4 Suppl 1):20-4.
Kotani A, Yonekura A, Bourne RB. Factors influencing range of motion after contemporary total knee arthroplasty. J Arthroplasty. 2005 Oct;20(7):850-6.
Jansen CM, Windau JE, Bonutti PM, Brillhart MV. Treatment of a knee contracture using a knee orthosis incorporating stress-relaxation techniques. Phys Ther. 1996 Feb;76(2):182-6.
Fitzgerald GK, Childs JD, Ridge TM, Irrgang JJ. Agility and perturbation training for a physically active individual with knee osteoarthritis. Phys Ther. 2002 Apr;82(4):372-82.
Laskin RS, Beksac B. Stiffness after total knee arthroplasty. J Arthroplasty. 2004 Jun;19(4 Suppl 1):41-6. Review.
Bourne RB, Laskin RS, Guerin JS. Ten-year results of the first 100 Genesis II total knee replacement procedures. Orthopedics. 2007 Aug;30(8 Suppl):83-5.
Bradbury N, Borton D, Spoo G, Cross MJ. Participation in sports after total knee replacement. Am J Sports Med. 1998 Jul-Aug;26(4):530-5.
Cloutier JM, Sabouret P, Deghrar A. Total knee arthroplasty with retention of both cruciate ligaments. A nine to eleven-year follow-up study. J Bone Joint Surg Am. 1999 May;81(5):697-702.
Kawamura H, Bourne RB. Factors affecting range of flexion after total knee arthroplasty. J Orthop Sci. 2001;6(3):248-52.
Kahle JT, Highsmith MJ, Hubbard SL. Comparison of nonmicroprocessor knee mechanism versus C-Leg on Prosthesis Evaluation Questionnaire, stumbles, falls, walking tests, stair descent, and knee preference. J Rehabil Res Dev. 2008;45(1):1-14.

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT00857701     History of Changes
Other Study ID Numbers: 2008.009
First Submitted: March 6, 2009
First Posted: March 9, 2009
Last Update Posted: August 12, 2013
Last Verified: August 2013

Keywords provided by Dynasplint Systems, Inc.:
total knee arthroplasty
Dynamic Splinting
Knee extension
knee
Reduced knee flexion after total knee arthroscopy


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