Formal vs. Home-Based Physical Therapy After Unicompartmental Knee Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02883998|
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Other: Outpatient Physical Therapy Other: Home Base Physical Therapy||Not Applicable|
Given that current practice trends are requiring treatments to be both clinically and cost effective, research has begun to focus on evaluating the effect of specific interventions. Many surgeon and patients have believed formal OPT is necessary to optimize functional outcomes following orthopaedic procedures. However, the literature has begun to call into question the need for OPT following total hip arthroplasty, total knee arthroplasty, total shoulder arthroplasty, anterior cruciate ligament reconstruction, meniscectomy, and rotator cuff repair.
A randomized controlled trial was done to compare face-to-face rehabilitation with in-home telerehabilitation following total knee arthroplasty. Utilizing the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as the primary outcome, the authors demonstrated noninferiority of telerehabilitation compared to face-to-face rehabilitation. Other secondary outcomes of Knee Injury and Osteoarthritis Outcome Score (KOOS), range of motion, and isometric strength did not exhibit a difference between the treatment groups. (see citation below)
Based on these findings, it appears that the high cost of formal OPT doesn't translate into a meaningful improvement of functional outcome. Because patient's undergoing UKA have a higher pre-operative functional status than patients having a TKA (Total Knee Arthroplasty), it is reasonable to think that patients following a UKA are better equipped to succeed with HBPT. As a result, the hypothesis of the current study is that HBPT will prove to be non-inferior to formal OPT in the setting of UKA.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Formal vs. Home-Based Physical Therapy After Unicompartmental Knee|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||December 2017|
Active Comparator: Outpatient Physical Therapy Group
Once the patient is cleared for discharged from the hospital, the patient will be given a prescription for outpatient physical therapy to attend 3 times per week for 6 weeks.
Other: Outpatient Physical Therapy
traditional outpatient physical therapy which occurs at a physical therapy office
Experimental: Home Base Physical Therapy Group
Patients will be provided a packet of exercises and equipment to perform the home based physical therapy program. Patients will attend a single session of outpatient physical therapy prior to surgery no more than 4 weeks prior to the procedure to teach the patient how to perform the exercises.
Other: Home Base Physical Therapy
Patients will be provided a packet of exercises via a website which allows access to instructional physical therapy videos specifically designated for UKA patients and equipment to perform the home based physical therapy
- Change from baseline in Knee Society Score [ Time Frame: at 3 weeks, 3 months, and 1 year after surgery ]
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: at 3 weeks, 3 months, and 1 year after surgery ]
- Change from baseline in Knee range of motion [ Time Frame: at 3 weeks, 3 months, and 1 year after surgery ]
- Complications [ Time Frame: Will be assessed at 3 weeks, 3 months, and 1 year after surgery ]Deep Vein Thrombosis or Pulmonary Embolus Return to the OR within 30 days Re-admission within 30 days Superficial infection Deep infection Periprosthetic fracture Knee stiffness (defined as < 90 degrees flexion at 3 weeks post-operative or < 110 degrees flexion at 6 weeks post-operative)
- Cost comparison [ Time Frame: Will be assessed at 3 weeks, 3 months, and 1 year after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883998
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Craig Della Valle, MD||Rush University Medical Center|