Clinical trial NCT02426190: Knee Arthroplasty Rehabilitation Outcomes Study
Official title: Knee Arthroplasty Rehabilitation Outcomes Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Rehabilitation
Lead sponsor: MedStar National Rehabilitation Network
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 386
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the KAROS study is to compare rehabilitation outcomes between 3 proposed protocols and a current standard of care protocol for the purpose of identifying better practice for outpatient rehabilitation among patients with single total knee replacement. The 3 advanced protocols involve use of an anti-gravity treadmill and/or the patterned electrical neuromuscular stimulation (PENS). Both medical modalities have been cleared by the FDA to be used in medical rehabilitation, including total knee replacement.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo an elective single total knee arthroplasty and initiate their outpatient rehabilitation therapy within 3 weeks after surgery.
* Patients who are 40 years old or older.
* Patients who weight less than 320 lb to accommodate the weight limit to use the anti-gravity treadmill.

Exclusion Criteria:

* Patients who had any lower extremity joint replacement less than 1 year prior the current total knee replacement.
* Patients who are pregnant or may be pregnant.
* Patients who have a medical history of neurologic disorders.
* Patients who have received more than 2 weeks of other formats of rehabilitation prior their outpatient rehabilitation program.
* Patients who received any cancer treatment in the past year prior the current surgery.
* Patients who have uncontrolled cardiovascular hypertension.
* Patients who have cardiac demand pacemakers and/or implanted defibrillators.

Primary outcomes:
measure: AM-PAC (Activity Measure for Post Acute Care) Basic Mobility score: Baseline
timeFrame: Baseline
measure: AM-PAC (Activity Measure for Post Acute Care) Basic Mobility score: Discharge from outpatient rehabilitation
timeFrame: Discharge from outpatient rehabilitation (on average 2 months from baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Network
state: District of Columbia
Study officials:
affiliation: MedStar National Rehabilitation Network
name: Michele Vita, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsieh CJ, DeJong G, Vita M, Zeymo A, Desale S. Effect of Outpatient Rehabilitation on Functional Mobility After Single Total Knee Arthroplasty: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2016571. doi: 10.1001/jamanetworkopen.2020.16571.
citation: DeJong G, Hsieh CJ, Vita MT, Zeymo A, Boucher HR, Thakkar SC. Innovative Devices Did Not Provide Superior Total Knee Arthroplasty Outcomes in Post-Operative Rehabilitation: Results From a Four-Arm Randomized Clinical Trial. J Arthroplasty. 2020 Aug;35(8):2054-2065. doi: 10.1016/j.arth.2020.03.048. Epub 2020 Apr 2.