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

NCT00591929 | Completed

• 1 other identifier: GHS-12-06-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Intra-articular Knee Fractures

Outcome Measures

Primary Outcomes (1)

• Knee Range of Motion

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

Study Arms (2)

1

NO INTERVENTION

No Continuous passive motion following ORIF of fractures around the knee

2

ACTIVE COMPARATOR

Continuous Passive Motion following ORIF of fractures around the knee

Other: Continuous Passive Motion

Interventions

Continuous Passive Motion OTHER

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

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (1)

Greenville Hospital System Univeristy Medical Center

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Interventions

Motion Therapy, Continuous Passive

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations

Study Officials

• Kyle J. Jeray, MD

  Greenville Hospital System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 11, 2008
• Study Start: December 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

US (1)