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

NCT ID: NCT02928835

Last Updated: 2016-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acquired Fixed Flexion Deformity of the Knee (Disorder)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dynasplint group

The experimental group received standardized physical therapy intervention and used the knee flexion Dynasplint orthosis six hours daily during one month, starting at day seven after total knee arthroplasty surgery.

Group Type EXPERIMENTAL

Knee flexion Dynasplint orthosis

Intervention Type DEVICE

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.

Control group

Control group received standardized physical therapy intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dynasplint

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role collaborator

Universidade Norte do Paraná

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eros de Oliveira Jr

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eros De Oliveira Jr, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Norte do Paraná

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Jean-Talon

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1097/00002060-199306000-00011.

Reference Type BACKGROUND
PMID: 8512680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18448878 (View on PubMed)

Shakespeare D, Kinzel V. Rehabilitation after total knee replacement: time to go home? Knee. 2005 Jun;12(3):185-9. doi: 10.1016/j.knee.2004.06.007. No abstract available.

Reference Type BACKGROUND
PMID: 15911290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16230234 (View on PubMed)

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. doi: 10.1054/arth.2003.50046.

Reference Type BACKGROUND
PMID: 12728419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24018464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19735563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19113998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22997557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18001629 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16445331 (View on PubMed)

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(7):1278-85. doi: 10.2106/00004623-200307000-00014.

Reference Type BACKGROUND
PMID: 12851353 (View on PubMed)

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. doi: 10.1097/00003086-200011000-00005.

Reference Type BACKGROUND
PMID: 11064970 (View on PubMed)

Beaupre 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.

Reference Type BACKGROUND
PMID: 11296803 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ethical Protocol n°: 11.049

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.