Acquired Fixed Flexion Deformity of the Knee (Disorder)NCT02928835

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

A study testing Knee flexion Dynasplint orthosis in people with Acquired Fixed Flexion Deformity of the Knee (Disorder), run by Universidade Norte do Paraná at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acquired Fixed Flexion Deformity of the Knee (Disorder)
What is being tested?: Knee flexion Dynasplint orthosis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteCanada
Study dates: Jun 2011to Nov 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Hôpital Jean-Talon
Montreal, Quebec, H2E 1S6

Other trials in Canada

About this study

Read the detailed 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.

Conditions: Acquired Fixed Flexion Deformity of the Knee (Disorder)
Being tested: Knee flexion Dynasplint orthosis
Keywords: Total knee arthroplasty, Knee flexion, Dynamic orthosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Knee flexion Dynasplint orthosisDevice
Also called Dynasplint
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.

Study groups in NCT02928835
Study group	Role	What they receive
Dynasplint group	Experimental	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. Receives: Device: Knee flexion Dynasplint orthosis
Control group	No intervention	Control group received standardized physical therapy intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline knee flexion angle at 6 months

Secondary outcomes (2)

Measures of knee function.
Assessed by the Knee Society Score (KSS)
Measured: Change from baseline knee flexion angle at 6 months
Measures for quality of life
Assessed by Short-form 36 Health Survey (SF-36)
Measured: Change from baseline knee flexion angle at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Nov 2013

First posted10 Oct 2016 (estimated)
Study startJun 2011
Primary completionNov 2012
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Acquired Fixed Flexion Deformity of the Knee (Disorder)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02928835
Sponsor's protocol ID: Ethical Protocol n°: 11.049
Status last verified: Oct 2016
First submitted: 6 Oct 2016
Last updated: 10 Oct 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 8512680
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.
PubMed 18448878
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.
PubMed 15911290
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.
PubMed 16230234
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.
PubMed 12728419
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.
PubMed 24018464
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.
PubMed 19735563
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.
PubMed 19113998
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.
PubMed 22997557
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.
PubMed 18001629
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.
PubMed 16445331
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.
PubMed 12851353
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.
PubMed 11064970
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.
PubMed 11296803

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02928835
Acronym / sponsor ID: Ethical Protocol n°: 11.049
Conditions: Acquired Fixed Flexion Deformity of the Knee (Disorder)
Keywords: Total knee arthroplasty, Knee flexion, Dynamic orthosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Universidade Norte do ParanáUniversity, hospital or other
Collaborators: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Study start: Jun 2011
Primary completion: Nov 2012 (actual)
Study completion: Nov 2013 (actual)
First posted: 10 Oct 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dynasplint group	Experimental	Device: Knee flexion Dynasplint orthosisThe 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.
Control group	No intervention	–Control group received standardized physical therapy intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Knee flexion Dynasplint orthosisAlso: DynasplintStandardized 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.	Device	Dynasplint group

Primary outcome

The knee flexion angle was assessed in supine position with a universal goniometer
Time frame: Change from baseline knee flexion angle at 6 months
The outcomes were obtained by one experienced and well-trained physical therapist.

2 secondary outcomes

Measures of knee function.
Time frame: Change from baseline knee flexion angle at 6 months
Measures for quality of life
Time frame: Change from baseline knee flexion angle at 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
Background: PubMed 8512680Nadler 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.
Background: PubMed 18448878Meier 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.
Background: PubMed 15911290Shakespeare 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.
Background: PubMed 16230234Kotani 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.
Background: PubMed 12728419Miner 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.
Background: PubMed 24018464Furia 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.
Background: PubMed 19735563Gaspar 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.
Background: PubMed 19113998Finger 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.
Background: PubMed 22997557Farahini 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.
Background: PubMed 18001629Kucera 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.
Background: PubMed 16445331Denis 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.
Background: PubMed 12851353Ritter 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eros De Oliveira Jr, PhD principal investigator

Universidade Norte do Paraná

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Knee flexion Dynasplint orthosis in people with Acquired Fixed Flexion Deformity of the Knee (Disorder), run by Universidade Norte do Paraná at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The knee flexion angle was assessed in supine position with a universal goniometer (time frame: Change from baseline knee flexion angle at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02928835, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2016.