Flexion Contracture
Conditions
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.
Interventions
DEVICEKneeMD
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.
Sponsors
Anne Arundel Health System Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AROM | 4 weeks after randomization | Change in maximal active range of motion in |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AROM | 2 weeks postoperatively | Active Range of motion in degrees |
Countries
United States
Outcome results
None listed