Measuring Every Day (MED) Study

NCT03010605 | Unknown

• 1 other identifier: MED
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

physical therapy post total knee replacement; range of motion; goniometry

Outcome Measures

Primary Outcomes (4)

• Index Knee Flexion of 90 degrees

  2 weeks post-op

• Index Knee Extension of -25 degrees

  2 weeks post-op

• Index Knee Flexion of 120 degrees

  6 weeks post-op

• Index Knee Extension of 0 degrees

  6 weeks post-op

Study Arms (2)

Standard of care physical therapy

ACTIVE COMPARATOR

Patients will receive 2 weeks of in-home physical therapy consisting of 3 sessions per week followed by 4 weeks of outpatient physical therapy three times weekly.

Other: Physical Therapy

MED Device

ACTIVE COMPARATOR

Patients will perform 10 repetitions with the MED device 3 times daily at 8am, 2pm, and 8pm and will transmit the 10th measurement of each time point to the clinicians office.

Device: Measuring Every Day Device

Interventions

Measuring Every Day Device DEVICE

Also known as: MED Device

MED Device

Physical Therapy OTHER

Standard of care physical therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is able to provide written informed consent.
• Age 18 - 64 years of age
• Subject has undergone successful unilateral total knee arthroplasty for degenerative joint disease
• Subject has access to an Apple device with Bluetooth capability
• Subject is able to demonstrate the capability of setting up and using an Apple application for remote data collection and transmission
• Subject is able to demonstrate capability of correctly using the MED device
• Subject is able to comply with post-operative visits and evaluations

You may not qualify if:

• Subject is scheduled for an index knee revision surgery
• Subject has pre-operative flexion range of motion less than 110 degrees
• Subject has a pre-operative flexion contracture greater than 15 degrees.
• Subject has additional joint replacement surgery scheduled within the six week study period

Sponsors & Collaborators

• The Christ Hospital: lead

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Study Start: January 1, 2017
• Primary Completion: June 14, 2018
• Study Completion: August 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

US (1)