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

NCT03260699 | Terminated Results FDA Device

• 1 other identifier: SHB-OCSI007
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Physical Therapy Visits

  Investigators will monitor the total number of physical therapy visits that was necessary to return to normal function between the control and bracing group and how it relates to overall cost.

  Total number of visits from date of surgery to 12 weeks after surgery

Secondary Outcomes (10)

• Visual Analog Scale (VAS) for Pain (0-10 Scale)

  Change from baseline to 12 weeks after surgery

• Timed up and go Test (Timed Measurement)

  Change from baseline to 12 weeks after surgery

• Timed Stair Climb (Timed Measurement Over Fixed Distance)

  Change from baseline to 12 weeks after surgery

• One-leg Stance Time (Timed Measurement)

  Change from baseline to 12 weeks after surgery

• 6 Minute Walk Test (Distance Measurement)

  Change from baseline to 12 weeks after surgery

Study Arms (2)

Control group

NO INTERVENTION

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

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.

Device: OCSI Rehabilitator brace

Interventions

OCSI Rehabilitator brace 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.

Bracing group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 50 years or older

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

• Title: Alison Klika, Research Manager
• Organization: Department of Orthopaedic Surgery, Cleveland Clinic

klikaa@ccf.org

216 444-4954

Study Officials

• Spindler Kurt, MD

  Department Chair

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: August 24, 2017
• Study Start: October 5, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 9, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-09

Locations

US (1)