Use of Continuous Passive Motion in the Post-Operative Treatment of Intra-articular Knee Fractures

March 11, 2013 updated by: Prisma Health-Upstate
Decreased range of motion is common after fractures around the knee and can impact a patient's ability to perform activities of daily living such as rising from a seated position or getting in and out of a bathtub. A continuous passive motion (CPM) machine is a machine that continuously moves a joint (such as the knee) without the patient having to use the muscles in his/her leg. A goal of this therapy is to maintain as much motion as possible following this injury. This study is a randomized, prospective study to evaluate the effectiveness of CPM in maintaining knee range of motion following open reduction and internal fixation (ORIF) of fractures around the knee

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System Univeristy Medical 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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • If the patient has an intra-articular distal femur or proximal tibia fracture
  • Independent ambulatory prior to injury
  • No previous knee injury limiting motion

Exclusion Criteria:

  • If the patients range of motion was decreased prior to injury (ex. Osteoarthritis, previous knee fracture or injury)
  • Any contraindication to CPM (concomitant hip or ankle fracture)
  • Open physis of tibia or distal femur
  • Pathological Fracture
  • Compartment Syndrome
  • Neurovascular injury
  • Fracture due to gunshot wound
  • Greater than 21 days from fracture to definitive open reduction and internal fixation
  • Fractures treated with definitive external fixation
  • Open fractures
  • Extensor mechanism injuries
  • Likely problems in the judgment of the investigator with maintaining follow-up

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
No Continuous passive motion following ORIF of fractures around the knee
Active Comparator: 2
Continuous Passive Motion following ORIF of fractures around the knee
Other: Continuous Passive Motion
at least 48 hours of continuous passive motion following ORIF of fractures around the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee Range of Motion
Time Frame: 48 hours, 2 weeks, 6 weeks, 3 months, 6 months and 1 year
48 hours, 2 weeks, 6 weeks, 3 months, 6 months and 1 year

Collaborators and Investigators

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

Sponsor

Prisma Health-Upstate

Collaborators

Orthopaedic Trauma Association

Investigators

  • Principal Investigator: Kyle J. Jeray, MD, Greenville Hospital System

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

December 1, 2006

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHS-12-06-03

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.

Subscribe