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

This study has been completed.
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier:
NCT00591929
First received: December 28, 2007
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention
Intra-articular Knee Fractures
 Other: Continuous Passive Motion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Continuous Passive Motion in the Post-Operative Treatment of Intra-articular Knee Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Greenville Hospital System University Medical Center:

Primary Outcome Measures:
  • Knee Range of Motion [ Time Frame: 48 hours, 2 weeks, 6 weeks, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2006
Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591929

Locations
United States, South Carolina
Greenville Hospital System Univeristy Medical Center
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Greenville Hospital System University Medical Center
Orthopaedic Trauma Association
Investigators
Principal Investigator: Kyle J. Jeray, MD Greenville Hospital System
  More Information

No publications provided

Responsible Party: Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier: NCT00591929     History of Changes
Other Study ID Numbers: GHS-12-06-03
Study First Received: December 28, 2007
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013