Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial

Acquired Fixed Flexion Deformity of the Knee (Disorder) Clinical Trial

Official title:

Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928835
• Other study ID #: Ethical Protocol n°: 11.049
• Status: Completed
• Phase: N/A
• First received: October 6, 2016
• Last updated: October 6, 2016
• Start date: June 2011
• Est. completion date: November 2013

Study information

• Verified date: October 2016
• Source: Universidade Norte do Paraná
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministère santé et services sociaux du Québec
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of a knee flexion Dynasplint orthosis on knee flexion angle after a total knee arthroplasty. Sixty participants, who underwent a total knee arthroplasty, were randomly assigned in two groups: control group and Dynasplint group.

Description:

Post-surgical rehabilitation interventions following total knee arthroplasty consist mainly of stretching exercises to improve flexibility and prevent soft tissue fibroses around the joint, thus, avoiding contractures and providing increases in the range of motion at the knee joint. Although knee manipulation and open arthrolysis may improve range of motion after total knee arthroplasty , the results have been variable and additional procedures are frequently necessary. Studies demonstrated the effectiveness of dynamic orthoses in reducing joint contractures after orthopedic surgeries in various joints that require a long rehabilitation period. Therefore, the purpose of the present study was to evaluate the effects of the knee flexion Dynasplint orthosis (KFD) on the length of rehabilitation and range of knee flexion angle after total knee arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients enrolled will have been schedule to receive first prosthesis of the knee:

Arthritis of the knee, dominated with pain Painful, deformed, and/or unstable knees secondary to degenerative or inflammatory conditions

Exclusion Criteria:

Fractures Knee sepsis Osteomyelitis or any orthopedic infection Psoriasis Knee joint neuropathy Previous Stroke or Brain Injury Significant pathology acquired secondary to the surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Fixed Flexion Deformity of the Knee (Disorder)
• Congenital Abnormalities

Intervention

Device:
• Knee flexion Dynasplint orthosis
Standardized rehabilitation procedures started at the first day after total knee arthroplasty. Both groups received the same standardized physical therapy intervention. The experimental group used the knee flexion Dynasplint orthosis (Dynasplint Systems, Inc. Canada, Woodbridge, ON) at night, while sleeping, over six continuous hours for one month, starting seven days after the total knee arthroplasty. The control group received only the standardized physical therapy intervention.

Locations

Country	Name	City	State
Canada	Hôpital Jean-Talon	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Norte do Paraná	Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

References & Publications (14)

Beaupré LA, Davies DM, Jones CA, Cinats JG. Exercise combined with continuous passive motion or slider board therapy compared with exercise only: a randomized controlled trial of patients following total knee arthroplasty. Phys Ther. 2001 Apr;81(4):1029-37. — View Citation

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. — View Citation

Farahini H, Moghtadaei M, Bagheri A, Akbarian E. Factors influencing range of motion after total knee arthroplasty. Iran Red Crescent Med J. 2012 Jul;14(7):417-21. Epub 2012 Jul 30. — View Citation

Finger E, Willis FB. Dynamic splinting for knee flexion contracture following total knee arthroplasty: a case report. Cases J. 2008 Dec 29;1(1):421. doi: 10.1186/1757-1626-1-421. — View Citation

Furia JP, Willis FB, Shanmugam R, Curran SA. Systematic review of contracture reduction in the lower extremity with dynamic splinting. Adv Ther. 2013 Aug;30(8):763-70. doi: 10.1007/s12325-013-0052-1. Epub 2013 Sep 10. Review. — View Citation

Gaspar PD, Willis FB. Adhesive capsulitis and dynamic splinting: a controlled, cohort study. BMC Musculoskelet Disord. 2009 Sep 7;10:111. doi: 10.1186/1471-2474-10-111. — View Citation

Kotani A, Yonekura A, Bourne RB. Factors influencing range of motion after contemporary total knee arthroplasty. J Arthroplasty. 2005 Oct;20(7):850-6. — View Citation

Kucera T, Urban K, Karpas K, Sponer P. [Restricted motion after total knee arthroplasty]. Acta Chir Orthop Traumatol Cech. 2007 Oct;74(5):326-31. Czech. — View Citation

MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW, Kramer J, Vaz M. Prospective randomized clinical trial of continuous passive motion after total knee arthroplasty. Clin Orthop Relat Res. 2000 Nov;(380):30-5. — View Citation

Meier W, Mizner RL, Marcus RL, Dibble LE, Peters C, Lastayo PC. Total knee arthroplasty: muscle impairments, functional limitations, and recommended rehabilitation approaches. J Orthop Sports Phys Ther. 2008 May;38(5):246-56. doi: 10.2519/jospt.2008.2715. Epub 2007 Dec 14. Review. — View Citation

Miner AL, Lingard EA, Wright EA, Sledge CB, Katz JN; Kinemax Outcomes Group. Knee range of motion after total knee arthroplasty: how important is this as an outcome measure? J Arthroplasty. 2003 Apr;18(3):286-94. — View Citation

Nadler SF, Malanga GA, Zimmerman JR. Continuous passive motion in the rehabilitation setting. A retrospective study. Am J Phys Med Rehabil. 1993 Jun;72(3):162-5. — View Citation

Ritter MA, Harty LD, Davis KE, Meding JB, Berend ME. Predicting range of motion after total knee arthroplasty. Clustering, log-linear regression, and regression tree analysis. J Bone Joint Surg Am. 2003 Jul;85-A(7):1278-85. — View Citation

Shakespeare D, Kinzel V. Rehabilitation after total knee replacement: time to go home? Knee. 2005 Jun;12(3):185-9. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The knee flexion angle was assessed in supine position with a universal goniometer	The outcomes were obtained by one experienced and well-trained physical therapist.	Change from baseline knee flexion angle at 6 months	No
Secondary	Measures of knee function.	Assessed by the Knee Society Score (KSS)	Change from baseline knee flexion angle at 6 months	No
Secondary	Measures for quality of life	Assessed by Short-form 36 Health Survey (SF-36)	Change from baseline knee flexion angle at 6 months	No