Clinical trial NCT05280639: 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
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Fractures
Pilon Fracture
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ankle Range of Motion (ROM)
timeFrame: 2 weeks after surgery
measure: Ankle ROM
timeFrame: 6 weeks after surgery
measure: Ankle ROM
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Self reported subject compliance with exercise program: number of days completed
timeFrame: 2 weeks after surgery
measure: Self reported subject compliance with exercise program: number of days completed
timeFrame: 6 weeks after surgery
measure: Lower Extremity Functional Scale score
timeFrame: 2 weeks after surgery.
measure: Lower Extremity Functional Scale score
timeFrame: 6 weeks after surgery.
measure: Lower Extremity Functional Scale score
timeFrame: 6 months after surgery.
measure: Pain and ankle Range of Motion
timeFrame: 2 weeks after surgery
measure: Pain and ankle Range of Motion
timeFrame: 6 weeks after surgery
measure: Pain and ankle Range of Motion
timeFrame: 6 months after surgery.
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: University of Virginia Orthopaedic Surgey
name: Seth Yarboro, MD
role: PRINCIPAL_INVESTIGATOR
References: