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

NCT ID: NCT00591929

Last Updated: 2013-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2013-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Intra-articular Knee Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

No Continuous passive motion following ORIF of fractures around the knee

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Continuous Passive Motion following ORIF of fractures around the knee

Group Type ACTIVE_COMPARATOR

Continuous Passive Motion

Intervention Type OTHER

at least 48 hours of continuous passive motion following ORIF of fractures around the knee

Interventions

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Continuous Passive Motion

at least 48 hours of continuous passive motion following ORIF of fractures around the knee

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orthopaedic Trauma Association

OTHER

Sponsor Role collaborator

Prisma Health-Upstate

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle J. Jeray, MD

Role: PRINCIPAL_INVESTIGATOR

Greenville Hospital System

Locations

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Greenville Hospital System Univeristy Medical Center

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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GHS-12-06-03

Identifier Type: -

Identifier Source: org_study_id

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