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Measuring Every Day (MED) Study

NCT03010605 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-07-18

No results posted yet for this study

Summary

Achieving adequate range of motion post Total Knee Arthroplasty(TKA) is an important goal for return to optimum function. Traditionally, adequate range of motion has been achieved by a combination of in-home and outpatient physical therapy. While physical therapy is successful, it has the limitation of cost and availability. As copayments rise, patients may decide that they cannot afford physical therapy, potentially compromising the outcome of their surgery and successful return to function.

It is assumed that having an easy and fun to use, patient administered, incentive device that provides accurate, quantitative flexion and extension measurements may accelerate patient mobility and return to function after TKA. The Measuring Every Day (MED) portable goniometer is commercially available and provides objective, consistent range of motion measurements that are recorded and can be sent electronically to the clinician's office potentially enabling earlier clinical or therapy adjustments or modifications to the prescribed therapy.

Goniometry is a commonly used tool to measure and document range of motion (ROM) during clinical evaluation or a physical therapy examination. The technique is used to assess the limitations of a patient's joint and provide information to the clinician that may help determine further treatment.

The study is designed to compare range of motion measurement data for 6 weeks in patients that have been randomized to receive either traditional physical therapy or the MED device. The hypothesis is that patients who use the MED device achieve equivalent range of motion at six weeks as compared to patients participating in traditional standard of care physical therapy.

Conditions

  • Total Knee Arthroplasty

Interventions

DEVICE

Measuring Every Day Device

OTHER

Physical Therapy

Sponsors & Collaborators

  • The Christ Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-06-14
Completion
2018-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03010605 on ClinicalTrials.gov