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Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures

Primary Purpose

Fractures, Bone

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPM
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fractures, Bone

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 or greater
  • Isolated acetabular fractures, supracondylar femur fractures, or tibial plateau fracture
  • Have undergone operative intervention for fracture

Exclusion Criteria:

  • Injury to either lower extremity that affects the patient's ability to weight bear
  • Under the age of 18
  • Pregnant
  • A prisoner

Sites / Locations

  • Univrsity of Cincinnati Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CPM

No CPM

Arm Description

The experimental group will have a CPM applied in the PACU immediately post-op and it will be utilized while the patient is awake in bed for 2 hours on and 2 hours off, when not mobilizing with Physical Therapy (PT). The experimental group will also have traditional PT, including sessions 1 to 3 times a week.

The control group will have typical care, including working with physical therapy 1 to 3 times a week.

Outcomes

Primary Outcome Measures

VAS Pain Score
Pain will be assessed by the patient on a scale of 1-10 during hospitalization. 1=no pain; 10=worst pain

Secondary Outcome Measures

SF-12
The Short Form 12 (SF-12) uses just 12 questions to measure functional health and well-being from the patient's point of view. An algorithm is used to generate the physical and mental health composite scores for comparison to normative data. The mean score is set to 50. Scores >50 indicate better physical or mental health than to mean. Scores <50 indicate worse physical or mental health than the mean.

Full Information

First Posted
April 26, 2020
Last Updated
October 31, 2022
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT04389749
Brief Title
Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures
Official Title
The Role of Continuous Passive Motion in Pain Control of Patients Undergoing Operative Management of Isolated Acetabular Fractures, Supracondylar Femur Fractures, or Tibial Plateau Fracture: A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will directly compare the visual analog scale scores and narcotic pain medication requirements in the patients who have continuous passive motion (CPM) versus those who do not during the course of the hospital admission following an open reduction internal fixation surgery for acetabular fracture, supracondylar femur fracture, or a tibial plateau fracture.
Detailed Description
This will be a prospective comparative cohort study analyzing the practices of three surgeons, one of whom routinely uses CPM following fixation of pelvic and acetabular fractures, and two surgeons who do not. All patients, over the age of 18 years who have undergone open reduction and internal fixation (ORIF) of isolated acetabular fractures, supracondylar femur fractures, or tibial plateau fracture will be asked to participate. Those who consent will be randomized into two groups. The experimental group will have a CPM applied in the PACU immediately post-op and it will be utilized while the patient is awake in bed for 2 hours on and 2 hours off, when not mobilizing with Physical Therapy (PT). The experimental group will also have traditional PT, including sessions 1 to 3 times a week. The control group will have typical care, including working with physical therapy 1 to 3 times a week. The investigators will directly compare the VAS scores and narcotic pain medication requirements in the patients who have CPM versus those who do not during the course of the hospital admission. VAS scores will be assessed throughout the day by RN and/or PT. Functional outcomes will be assessed at the one-year mark using the Iowa and Majeed pelvic functional outcome tools along with the SF-12. Orthopedic Resident or Nurse Clinical will check the patient for incision integrity each day and each session of using the CPM, the patient will be monitored for adverse events. Data will be collected using Epic. The investigators will record patient demographics including age, sex, and pre-existing narcotic usage. Fracture type according to the Orthopaedic Trauma Association will be recorded. VAS scores and pain medication requirements will be recorded from the first 48 hours during the patient's stay. Pain scores and CPM use will be obtained from Epic using the flowsheet. Functional outcomes will be assessed at the one-year mark using the Iowa and Majeed pelvic functional outcome tools along with the SF-12.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective comparative cohort study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPM
Arm Type
Experimental
Arm Description
The experimental group will have a CPM applied in the PACU immediately post-op and it will be utilized while the patient is awake in bed for 2 hours on and 2 hours off, when not mobilizing with Physical Therapy (PT). The experimental group will also have traditional PT, including sessions 1 to 3 times a week.
Arm Title
No CPM
Arm Type
No Intervention
Arm Description
The control group will have typical care, including working with physical therapy 1 to 3 times a week.
Intervention Type
Device
Intervention Name(s)
CPM
Intervention Description
CPM-continuous passive motion device.
Primary Outcome Measure Information:
Title
VAS Pain Score
Description
Pain will be assessed by the patient on a scale of 1-10 during hospitalization. 1=no pain; 10=worst pain
Time Frame
Visual Analog Score for pain will be recorded daily after the surgery each day until the patient is discharged or up to 365 days..
Secondary Outcome Measure Information:
Title
SF-12
Description
The Short Form 12 (SF-12) uses just 12 questions to measure functional health and well-being from the patient's point of view. An algorithm is used to generate the physical and mental health composite scores for comparison to normative data. The mean score is set to 50. Scores >50 indicate better physical or mental health than to mean. Scores <50 indicate worse physical or mental health than the mean.
Time Frame
This score will be completed at the one-year post-operative visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or greater Isolated acetabular fractures, supracondylar femur fractures, or tibial plateau fracture Have undergone operative intervention for fracture Exclusion Criteria: Injury to either lower extremity that affects the patient's ability to weight bear Under the age of 18 Pregnant A prisoner
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly A Hasselfeld, MS
Phone
513-558-1933
Email
hasselky@uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry C Sagi, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univrsity of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Hasselfeld, MS
Phone
513-777-6213
Email
hasselky@uc.edu
First Name & Middle Initial & Last Name & Degree
Henry Sagi, MD
Phone
5137776213

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures

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