- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02638480
Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients (KneeMD)
A Prospective Randomized Trial to Examine the Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients
Study Overview
Detailed Description
Postoperative flexion contracture (FC), defined as >10°, is the most common disabling early complication of primary total knee replacement (TKR) surgery, affecting up to 6% of all subjects. A knee flexion of 65° is required to walk, 70° is needed to lift an object from the floor, 85° to climb stairs, 95° for optimal sitting and standing, and 105° to tie shoelaces. With growing subject and physician expectations for function and range of motion (ROM) after surgery, FC complications have become an early measure of success in TKR surgery.
The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee rehabilitation device on the incidence of postoperative FC. The primary endpoints are the preoperative change in active range of motion (AROM) and the incidence of postoperative FC at 2 weeks. Secondary endpoints include the change in AROM in subjects with postoperative FC.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Annapolis, Maryland, United States, 21401
- Anne Arundel Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Measurable Knee Flexion Contracture, with deficit limiting Active Range of Motion (AROM) and Passive Range of Motion (PROM) by at least - 10°
- 18 years of age and older
- Able to understand informed consent and willingness to conform to trial responsibilities
Exclusion Criteria:
- Previous surgical treatment of knee, including tibial osteotomy
- Botulinum Toxin Treatment within the last four months
- Mechanical joint impingement
- Neuromuscular pathologies such as epilepsy
- Treatment with quinolone, antibiotic medication
- Pregnant or nursing
- Fractures
- Osteomyelitis or any orthopedic infection
- Extensor mechanism dysfunction
- Knee joint neuropathy
- Previous Stroke or Brain Injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
The control subjects will be treated with only the current SOC including NSAIDs and physical therapy.
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|
Experimental: Experimental
The experimental subjects will be treated with current SOC and will also use a kneeMD splint 3 times a day for 20 minutes per session
|
KneeMD is a subject-controlled knee rehabilita¬tion device that helps subjects who have undergone total knee replacements or other major knee surger¬ies improve range of motion and stretch in extension.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AROM
Time Frame: 4 weeks after randomization
|
Change in maximal active range of motion in
|
4 weeks after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AROM
Time Frame: 2 weeks postoperatively
|
Active Range of motion in degrees
|
2 weeks postoperatively
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Gonzalez Della Valle A, Leali A, Haas S. Etiology and surgical interventions for stiff total knee replacements. HSS J. 2007 Sep;3(2):182-9. doi: 10.1007/s11420-007-9053-4.
- Pariente GM, Lombardi AV Jr, Berend KR, Mallory TH, Adams JB. Manipulation with prolonged epidural analgesia for treatment of TKA complicated by arthrofibrosis. Surg Technol Int. 2006;15:221-4.
- Yercan HS, Sugun TS, Bussiere C, Ait Si Selmi T, Davies A, Neyret P. Stiffness after total knee arthroplasty: prevalence, management and outcomes. Knee. 2006 Mar;13(2):111-7. doi: 10.1016/j.knee.2005.10.001. Epub 2006 Feb 20.
- Laubenthal KN, Smidt GL, Kettelkamp DB. A quantitative analysis of knee motion during activities of daily living. Phys Ther. 1972 Jan;52(1):34-43. doi: 10.1093/ptj/52.1.34. No abstract available.
- Schurman DJ, Parker JN, Ornstein D. Total condylar knee replacement. A study of factors influencing range of motion as late as two years after arthroplasty. J Bone Joint Surg Am. 1985 Sep;67(7):1006-14.
- Mitsuyasu H, Matsuda S, Miura H, Okazaki K, Fukagawa S, Iwamoto Y. Flexion contracture persists if the contracture is more than 15 degrees at 3 months after total knee arthroplasty. J Arthroplasty. 2011 Jun;26(4):639-43. doi: 10.1016/j.arth.2010.04.023. Epub 2010 Jun 11.
- Ritter MA, Lutgring JD, Davis KE, Berend ME, Pierson JL, Meneghini RM. The role of flexion contracture on outcomes in primary total knee arthroplasty. J Arthroplasty. 2007 Dec;22(8):1092-6. doi: 10.1016/j.arth.2006.11.009.
- Goudie ST, Deakin AH, Ahmad A, Maheshwari R, Picard F. Flexion contracture following primary total knee arthroplasty: risk factors and outcomes. Orthopedics. 2011 Dec 6;34(12):e855-9. doi: 10.3928/01477447-20111021-18.
- Aderinto J, Brenkel IJ, Chan P. Natural history of fixed flexion deformity following total knee replacement: a prospective five-year study. J Bone Joint Surg Br. 2005 Jul;87(7):934-6. doi: 10.1302/0301-620X.87B7.15586.
- Lam LO, Swift S, Shakespeare D. Fixed flexion deformity and flexion after knee arthroplasty. What happens in the first 12 months after surgery and can a poor outcome be predicted? Knee. 2003 Jun;10(2):181-5. doi: 10.1016/s0968-0160(02)00102-3.
- Koh IJ, Chang CB, Kang YG, Seong SC, Kim TK. Incidence, predictors, and effects of residual flexion contracture on clinical outcomes of total knee arthroplasty. J Arthroplasty. 2013 Apr;28(4):585-90. doi: 10.1016/j.arth.2012.07.014. Epub 2012 Nov 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 811229
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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