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Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients (KneeMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638480
Recruitment Status : Active, not recruiting
First Posted : December 23, 2015
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Anne Arundel Health System Research Institute

Tracking Information
First Submitted Date  ICMJE December 18, 2015
First Posted Date  ICMJE December 23, 2015
Last Update Posted Date February 8, 2019
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
AROM [ Time Frame: 4 weeks after randomization ]
Change in maximal active range of motion in
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
AROM [ Time Frame: 2 weeks postoperatively ]
Active Range of motion in degrees
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients
Official Title  ICMJE A Prospective Randomized Trial to Examine the Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients
Brief Summary The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee rehabilitation device on the incidence of postoperative flexion contracture.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Flexion Contracture
Intervention  ICMJE Device: KneeMD
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.
Study Arms  ICMJE
  • No Intervention: Control
    The control subjects will be treated with only the current SOC including NSAIDs and physical therapy.
  • 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
    Intervention: Device: KneeMD
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Measurable Knee Flexion Contracture, with deficit limiting Active Range of Motion (AROM) and Passive Range of Motion (PROM) by at least - 10°
  2. 18 years of age and older
  3. Able to understand informed consent and willingness to conform to trial responsibilities

Exclusion Criteria:

  1. Previous surgical treatment of knee, including tibial osteotomy
  2. Botulinum Toxin Treatment within the last four months
  3. Mechanical joint impingement
  4. Neuromuscular pathologies such as epilepsy
  5. Treatment with quinolone, antibiotic medication
  6. Pregnant or nursing
  7. Fractures
  8. Osteomyelitis or any orthopedic infection
  9. Extensor mechanism dysfunction
  10. Knee joint neuropathy
  11. Previous Stroke or Brain Injury
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02638480
Other Study ID Numbers  ICMJE 811229
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne Arundel Health System Research Institute
Study Sponsor  ICMJE Anne Arundel Health System Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Anne Arundel Health System Research Institute
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP