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

Primary Purpose

Intra-articular Knee Fractures

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Continuous Passive Motion

About this trial

This is an interventional treatment trial for Intra-articular Knee Fractures

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Greenville Hospital System Univeristy Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Arm Description

No Continuous passive motion following ORIF of fractures around the knee

Continuous Passive Motion following ORIF of fractures around the knee

Outcomes

Primary Outcome Measures

Knee Range of Motion

Secondary Outcome Measures

Full Information

NCT ID

NCT00591929

First Posted

December 28, 2007

Last Updated

March 11, 2013

Sponsor

Prisma Health-Upstate

Collaborators

Orthopaedic Trauma Association

1. Study Identification

Unique Protocol Identification Number

NCT00591929

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Prisma Health-Upstate

Collaborators

Orthopaedic Trauma Association

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intra-articular Knee Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

No Continuous passive motion following ORIF of fractures around the knee

Arm Title

Arm Type

Active Comparator

Arm Description

Continuous Passive Motion following ORIF of fractures around the knee

Intervention Type

Other

Intervention Name(s)

Continuous Passive Motion

Intervention Description

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

Primary Outcome Measure Information:

Title

Knee Range of Motion

Time Frame

48 hours, 2 weeks, 6 weeks, 3 months, 6 months and 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyle J. Jeray, MD

Organizational Affiliation

Greenville Hospital System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Greenville Hospital System Univeristy Medical Center

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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