NCT00857701

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

6.3 years

First QC Date

March 6, 2009

Last Update Submit

August 8, 2013

Conditions

Reduced Knee Flexion

Keywords

total knee arthroplastyDynamic SplintingKnee extensionkneeReduced knee flexion after total knee arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Change in Maximal Acitive Range of Mothion in knee extension

    9 weeks

Study Arms (2)

1

NO INTERVENTION

Patient will receive post-surgical standard of care treatment with standard Physical therapy and NSAIDs.

2

EXPERIMENTAL

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

Interventions

Knee Extension DynasplintDEVICE

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.

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Fractures
  • Knee sepsis
  • Osteomyelitis or any orthopedic infection
  • Extensor mechanism dysfunction
  • Psoriasis
  • Knee joint neuropathy
  • Previous Stroke or Brain Injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dennis L Armstrong M.D.

Mesa, Arizona, 85206, United States

Location

Related Publications (11)

  • 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.

    PMID: 16445331BACKGROUND

  • 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.

    PMID: 17570272BACKGROUND

  • 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.

    PMID: 16230234BACKGROUND

  • 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.

    PMID: 8592722BACKGROUND

  • 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.

    PMID: 11922853BACKGROUND

  • 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.

    PMID: 15190548BACKGROUND

  • 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.

    PMID: 17824343BACKGROUND

  • 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.

    PMID: 9689373BACKGROUND

  • 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.

    PMID: 10360698BACKGROUND

  • 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.

    PMID: 11484119BACKGROUND

  • 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.

    PMID: 18566922BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2015

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

US(1)