Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients

Anne Arundel Health System Research Institute

Status: Unknown

Conditions: Flexion Contracture

Treatments: Device: KneeMD

Study type: Interventional

Funder types: Other

Identifiers

NCT02638480

811229

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control

No Intervention group

Description:

The control subjects will be treated with only the current SOC including NSAIDs and physical therapy.

Experimental

Experimental group

Description:

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

Treatment:

Device: KneeMD