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Simplified Post Op Rehabilitation for Ankle and Pilon Fractures

Primary Purpose

Ankle Fractures, Pilon Fracture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wooden block
Formal physical therapy or Home Exercise Program
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 18-65
  • Surgically treated open or closed fractures of the ankle or tibial plafond

Exclusion Criteria:

  • Contralateral lower extremity injuries that would limit weight bearing after 6 weeks
  • Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)
  • Neurological deficits that would impede ability to stand safely unassisted for home exercise regiment
  • Desire to participate in formal physical therapy program
  • Additional injury that would compromise subjects ability to follow either Home Exercise Program
  • Non ambulatory prior to injury
  • Previous ankle or tibial plafond injury on ipsilateral extremity
  • BMI > 50
  • Severe problems maintaining follow up
  • Previous ankle/tibial plafond fracture
  • Prisoners
  • Neurological impairments that impair balance

Sites / Locations

  • University of Virginia Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simplified block protocol

Usual care

Arm Description

subjects in this group will perform a simplified post operative rehabilitation program using a simplified wooden block protocol

Subjects in this group will perform formal physical therapy or a home exercise program consistent with AAOS standards.

Outcomes

Primary Outcome Measures

Ankle Range of Motion (ROM)
maximum plantarflexion and maximum dorsiflexion
Ankle ROM
maximum plantarflexion and maximum dorsiflexion
Ankle ROM
maximum plantarflexion and maximum dorsiflexion

Secondary Outcome Measures

Self reported subject compliance with exercise program: number of days completed
Comparison of compliance between a full American Academy of Orthopaedic Surgeons (AAOS) home exercise program/formal physical therapy visits and the simplified ankle dorsiflexion with a wooden block
Self reported subject compliance with exercise program: number of days completed
Comparison of compliance between a full AAOS home exercise program/formal physical therapy visits and the simplified ankle dorsiflexion with a wooden block
Lower Extremity Functional Scale score
Comparison of Lower Extremity Functional Scale score (0 to 80 points) between and within groups. A higher score means better function.
Lower Extremity Functional Scale score
Comparison of Lower Extremity Functional Scale score (0 to 80 points) between and within groups. A higher score means better function.
Lower Extremity Functional Scale score
Comparison of Lower Extremity Functional Scale score (0 to 80 points) between and within groups. A higher score means better function.
Pain and ankle Range of Motion
Comparison of analog pain scores (Visual Analog Scale 0-100mm) between and within groups to gauge relationship of pain and ankle range of motion. Lower visual analog scale indicates less pain and higher Range of Motion means better ankle movement.
Pain and ankle Range of Motion
Comparison of analog pain scores (Visual Analog Scale 0-100mm) between and within groups to gauge relationship of pain and ankle range of motion. Lower visual analog scale indicates less pain and higher Range of Motion means better ankle movement.
Pain and ankle Range of Motion
Comparison of analog pain scores (Visual Analog Scale 0-100mm) between and within groups to gauge relationship of pain and ankle range of motion. Lower visual analog scale indicates less pain and higher Range of Motion means better ankle movement.

Full Information

First Posted
September 28, 2021
Last Updated
May 18, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05280639
Brief Title
Simplified Post Op Rehabilitation for Ankle and Pilon Fractures
Official Title
Ankle and Pilon Fracture Post Operative Rehabilitation: A Randomized Control Trial Exploring a Simplified Wooden Block Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.
Detailed Description
Ankle fractures and pilon fractures represent common injuries in orthopedics. These injuries are addressed with re-aligning the bones with surgery, and in some particular cases, they are treated closed reduction and immobilization during healing. The trauma to the ankle as a result of the injury, the prolonged immobilization in a cast or splint and the scar tissue formed during surgery often lead to post injury and post-operative stiffness. Many patients have limited ability to flex the ankle upward (dorsiflexion) following cast or splint removal for these injuries. Physical therapy and rehabilitation represent an an industry-accepted practice for alleviating stiffness and improving function. Currently there are varying studies on the benefits of manual therapy or passive stretch when compared with exercise alone. Neither a supervised exercise program such as formal physical therapy nor a home exercise regiment offer a clear benefit over the other, leading to the question of, if this process can be further simplified to use with the wooden block. The main functional complaint of patients is "stiffness" or decreased range of motion is in dorsiflexion of the ankle and is cited at approximately 77% of patients following cast or splint removal. This motion is key when walking normally, descending stairs or kneeling and is important to a greater degree when walking up hills , running or rising from a chair. These activities require 10 degrees passive dorsiflexion and 20 degrees on average, respectively. The functional effects of limited ankle dorsiflexion sometimes results in the need for a shoe heel insert or additional surgical procedures to free up the scar in the front of the ankle. This randomized control trial aims to analyze two currently-used standards of care for ankle and tibial plafond injuries, simplifying the standard post-operative physical therapy/rehabilitation regiment, which would begin a the time of rigid splint removal, when stretching and range of motion is tolerated. Weight bearing with ambulation is slowly adjusted for the weeks following this. This simplified wooden block protocol ankle exercises focus strictly on ankle dorsiflexion using a wooden block. The investigators aim of doing so is to increase compliance with the exercises and with an improved functional outcome as compared with the standard, more complex exercises and time burdensome options. The aim of this study is to compare the standard post injury/surgery rehabilitation with this new simplified wooden block stretching protocol and analyze the simplified protocol's effectiveness verses other industry accepted exercises/therapy regiments. This study will evaluate pain scores, compliance, range of motion of the ankle and include a Lower Extremity Functionality Score survey, over the course of 3 standard post-operative visits following the subjects injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures, Pilon Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simplified block protocol
Arm Type
Experimental
Arm Description
subjects in this group will perform a simplified post operative rehabilitation program using a simplified wooden block protocol
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Subjects in this group will perform formal physical therapy or a home exercise program consistent with AAOS standards.
Intervention Type
Device
Intervention Name(s)
Wooden block
Intervention Description
Individuals randomized to this group will be given a wooden block at no cost to them and a simplified version of home, self-guided exercises with instructions on how to do the exercises and how often to do so.
Intervention Type
Other
Intervention Name(s)
Formal physical therapy or Home Exercise Program
Intervention Description
Individuals randomized to this group will receive the standard formal physical therapy which are sessions run by a physical therapist, usually 2-3 times a week to rehabilitate their ankle OR follow a standardized home exercise program which will be done by yourself with exercise outlined with how they should be performed and how often
Primary Outcome Measure Information:
Title
Ankle Range of Motion (ROM)
Description
maximum plantarflexion and maximum dorsiflexion
Time Frame
2 weeks after surgery
Title
Ankle ROM
Description
maximum plantarflexion and maximum dorsiflexion
Time Frame
6 weeks after surgery
Title
Ankle ROM
Description
maximum plantarflexion and maximum dorsiflexion
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Self reported subject compliance with exercise program: number of days completed
Description
Comparison of compliance between a full American Academy of Orthopaedic Surgeons (AAOS) home exercise program/formal physical therapy visits and the simplified ankle dorsiflexion with a wooden block
Time Frame
2 weeks after surgery
Title
Self reported subject compliance with exercise program: number of days completed
Description
Comparison of compliance between a full AAOS home exercise program/formal physical therapy visits and the simplified ankle dorsiflexion with a wooden block
Time Frame
6 weeks after surgery
Title
Lower Extremity Functional Scale score
Description
Comparison of Lower Extremity Functional Scale score (0 to 80 points) between and within groups. A higher score means better function.
Time Frame
2 weeks after surgery.
Title
Lower Extremity Functional Scale score
Description
Comparison of Lower Extremity Functional Scale score (0 to 80 points) between and within groups. A higher score means better function.
Time Frame
6 weeks after surgery.
Title
Lower Extremity Functional Scale score
Description
Comparison of Lower Extremity Functional Scale score (0 to 80 points) between and within groups. A higher score means better function.
Time Frame
6 months after surgery.
Title
Pain and ankle Range of Motion
Description
Comparison of analog pain scores (Visual Analog Scale 0-100mm) between and within groups to gauge relationship of pain and ankle range of motion. Lower visual analog scale indicates less pain and higher Range of Motion means better ankle movement.
Time Frame
2 weeks after surgery
Title
Pain and ankle Range of Motion
Description
Comparison of analog pain scores (Visual Analog Scale 0-100mm) between and within groups to gauge relationship of pain and ankle range of motion. Lower visual analog scale indicates less pain and higher Range of Motion means better ankle movement.
Time Frame
6 weeks after surgery
Title
Pain and ankle Range of Motion
Description
Comparison of analog pain scores (Visual Analog Scale 0-100mm) between and within groups to gauge relationship of pain and ankle range of motion. Lower visual analog scale indicates less pain and higher Range of Motion means better ankle movement.
Time Frame
6 months after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18-65 Surgically treated open or closed fractures of the ankle or tibial plafond Exclusion Criteria: Contralateral lower extremity injuries that would limit weight bearing after 6 weeks Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively) Neurological deficits that would impede ability to stand safely unassisted for home exercise regiment Desire to participate in formal physical therapy program Additional injury that would compromise subjects ability to follow either Home Exercise Program Non ambulatory prior to injury Previous ankle or tibial plafond injury on ipsilateral extremity BMI > 50 Severe problems maintaining follow up Previous ankle/tibial plafond fracture Prisoners Neurological impairments that impair balance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric McVey, MEd
Phone
434.243.5382
Email
edm9u@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Yarboro, MD
Organizational Affiliation
University of Virginia Orthopaedic Surgey
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Elder
Phone
434-924-8570
Email
LJE5U@uvahealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Simplified Post Op Rehabilitation for Ankle and Pilon Fractures

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