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

NCT ID: NCT03260699

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-05
• Study Completion Date: 2018-01-01

Brief Summary

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.

Conditions

Arthropathy of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Bracing group

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.

Group Type: EXPERIMENTAL

OCSI Rehabilitator brace

Intervention Type: DEVICE

Guardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces. Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear.

Interventions

OCSI Rehabilitator brace

Guardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces. Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Age: 50 years or older

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Carlos Higuera-Rueda

Staff Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Spindler Kurt, MD

Role: STUDY_CHAIR

Department Chair

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SHB-OCSI007

Identifier Type: -

Identifier Source: org_study_id