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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

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.

Condition or disease Intervention/treatment Phase
Flexion Contracture Device: KneeMD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial to Examine the Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients
Study Start Date : November 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. AROM [ Time Frame: 4 weeks after randomization ]
    Change in maximal active range of motion in


Secondary Outcome Measures :
  1. AROM [ Time Frame: 2 weeks postoperatively ]
    Active Range of motion in degrees



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638480


Locations
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United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Sponsors and Collaborators
Anne Arundel Health System Research Institute
Publications:

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Responsible Party: Anne Arundel Health System Research Institute
ClinicalTrials.gov Identifier: NCT02638480    
Other Study ID Numbers: 811229
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases