Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
25 participants
INTERVENTIONAL
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Patient will receive post-surgical standard of care treatment with standard Physical therapy and NSAIDs.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Pain that is worsened by bending over while legs are straight
* Impaired gait pattern
* Ability to understand informed consent and experiment responsibilities
Exclusion Criteria
* Knee sepsis
* Osteomyelitis or any orthopedic infection
* Extensor mechanism dysfunction
* Psoriasis
* Knee joint neuropathy
* Previous Stroke or Brain Injury
18 Years
90 Years
ALL
No
Sponsors
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Dynasplint Systems, Inc.
INDUSTRY
Responsible Party
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Locations
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Dennis L Armstrong M.D.
Mesa, Arizona, United States
Countries
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References
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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. doi: 10.1016/j.arth.2006.12.110.
Kotani A, Yonekura A, Bourne RB. Factors influencing range of motion after contemporary total knee arthroplasty. J Arthroplasty. 2005 Oct;20(7):850-6. doi: 10.1016/j.arth.2004.12.051.
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. doi: 10.1093/ptj/76.2.182.
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. doi: 10.1016/j.arth.2004.02.008.
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. doi: 10.1177/03635465980260041001.
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. doi: 10.2106/00004623-199905000-00011.
Kawamura H, Bourne RB. Factors affecting range of flexion after total knee arthroplasty. J Orthop Sci. 2001;6(3):248-52. doi: 10.1007/s007760100043.
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. doi: 10.1682/jrrd.2007.04.0054.
Other Identifiers
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2008.009
Identifier Type: -
Identifier Source: org_study_id