Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)

NeuroTherapia, Inc.

Status: Terminated

Conditions: Arthropathy of Knee

Treatments: Device: OCSI Rehabilitator brace

Study type: Interventional

Funder types: Other

Identifiers

NCT03260699

SHB-OCSI007

Details and patient eligibility

About

While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined. Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.

Enrollment: 9 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age: 50 years or older

Exclusion criteria

• BMI > 40
• Radiographic deformity of greater than 10 degrees

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Control group

No Intervention group

Description:

Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA.

Bracing group

Experimental group

Description:

Subjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery. This brace will be worn for 6 weeks before surgery. The brace will be worn again after surgery \~10 days after surgery or when staples are removed until the end of the study. Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion.

Treatment:

Device: OCSI Rehabilitator brace