Static Progressive Splinting in the Management of Knee Stiffness Following Total Knee Arthroplasty

April 8, 2021 updated by: University of Colorado, Denver
The purpose of this study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following total knee arthroplasty (TKA). Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to manipulation under anesthesia (MUA) which is the current standard of care for knee stiffness after TKA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty (TKA) is the standard of care to manage the pain and disability associated with end-stage knee osteoarthritis, with more than 700,000 TKA surgeries performed annually in the United States. Knee stiffness, commonly caused by arthrofibrosis, is an infrequent, but debilitating complication of TKA, with an incidence upwards of 5% postoperatively. As a predominant failure mechanism, knee stiffness accounts for 28% of hospital readmissions due to surgical complications within 90 days of discharge, and 10% of all revisions within 5 years of initial surgery within the United States. With the incidence of TKA projected to reach 3.5 million by 2030, the growing cohort of TKA patients with postoperative knee stiffness provides an important target for research.

Several treatments for knee stiffness have been described including static progressive splinting and manipulation under anesthesia (MUA). To date, no studies have compared the use of static progressive splinting in the early management of individuals presenting with knee stiffness after TKA to more commonly utilized surgical procedures such as MUA. Witvrouw and colleagues compared a computer-controlled passive motion device to MUA for individuals with knee stiffness after TKA and found that stretching device had similar outcomes to MUA in terms of range of motion (ROM) and self-reported pain, stiffness and function. A key limitation of this study is that the computer-controlled motion device is not commercially available and therefore translation of this technology into practice is unlikely. However, this study does demonstrate that conservative stretching techniques may be as efficacious as costlier surgical techniques as well as may cause fewer adverse events such as quadriceps tendon rupture and fractures. Only one study to date has examined the utilization of static progressive splinting after TKA. In this study, they enrolled patients who had already failed MUA and conservative physical therapy management strategies. They found that the average ROM increase for patients was 25° as well as 92% of patients were satisfied with the results and no complications occurred with use of the device. Key limitations to this study are the lack of a comparison group as well as static progressive splinting was utilized after MUA had already failed. It is unknown how individuals would respond to this treatment compared to MUA.

Therefore, the purpose of our study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following TKA within the current surgical practice of Dr. Jared Foran at Panorama Orthopedics & Spine Center. Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to MUA which is the current standard of care for knee stiffness after TKA.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Panorama Orthopedics & Spine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergone a unilateral primary Total Knee Arthroplasty (TKA) for end-stage osteoarthritis
  • Knee stiffness in the first 6 weeks post-operative defined as knee flexion < 100 degrees

Exclusion Criteria:

  • Preoperative knee range of motion less than 15-110 degrees
  • Intraoperative (closed) range of motion < 0-120 degrees
  • Radiographic signs of heterotopic ossification
  • Misaligned components or component-related failures of knee prosthesis that could be responsible for difficulties with motion
  • Signs and symptoms consistent with joint infection
  • Signs and symptoms consistent with complex regional pain syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal Physical Therapy (MPT)
The multimodal physical therapy (MPT) program consisted of manual therapy, therapeutic exercise, and utilization of a static progressive splint (Joint Active Systems SPS Knee, Effingham, IL). Although the primary focus of this study was on improving knee flexion ROM, two protocols were developed: one to improve flexion deficits and one to improve extension deficits. Participants in the MPT group received physical therapy 2x per week for 4 weeks. They were instructed to use the static progressive splint(s) 3x per day for 30 minute sessions (90 minutes total per day) for each splint (e.g., 90 minutes for flexion splint, 90 minutes for extension splint).
Other: Multimodal Physical Therapy (MPT)
Individualized physical therapy and static progressive splint (flexion with or without extension splint).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: 4 weeks
Passive knee flexion and extension measured with goniometry
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Splint Use
Time Frame: 4 weeks
Adherence to splint use was tracked with a log completed by participants; they were instructed to place a checkmark for each day they used the JAS splint per protocol (30-minute sessions, 3 times daily). Adherence was calculated as days of splint use completed divided by days of splint use prescribed; a priori adherence levels were considered acceptable if the mean was ≥ 80 percent.
4 weeks
Satisfaction with Splint
Time Frame: 4 weeks
Satisfaction was assessed with a 7-point Likert scale ranging from 1 "extremely dissatisfied" to 7 "extremely satisfied". Participants responded based on the following instruction: please rate your satisfaction with your knee splint on the scale. A priori satisfaction was considered acceptable if the median score was ≥ 4 ("somewhat satisfied" or higher).
4 weeks
Safety of splint use: adverse events
Time Frame: 4 weeks
Count and description of adverse events related to splint use
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Panorama Orthopedics & Spine Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2017

Primary Completion (Actual)

February 27, 2018

Study Completion (Actual)

February 12, 2019

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-0241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthroplasty, Replacement, Knee

Clinical Trials on Multimodal Physical Therapy (MPT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe