Prevalence of Flexor Hallucis Longus Tears, Associated Os Trigonum Excision, and Return to Play

NCT ID: NCT04467099

Last Updated: 2021-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-02

Study Completion Date

2022-08-31

Brief Summary

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The study's aim is to determine the incidence of flexor hallucis tendon tears associated with os trigonum excision. The study will then compare the length until functional return to play of the patients who had flexor hallucis tendon tears with concomitant os trigonum excision versus those without flexor hallucis tendon tears who underwent os trigonum excision. Lastly, the study will be evaluating the patient complaints and physical exam findings before and after surgery and compare those without flexor hallucis tendon tears to those with flexor hallucis tendon repair.

Detailed Description

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Posterior ankle pain syndrome has many etiologies. Two main causes of this are flexor hallucis tendon tear and os trigonum impingement. The current teaching is that patients with flexor hallucis longus tear complain of posterior medial ankle pain and those with posterior lateral ankle pain have an os trigonum impingement. It is also classically understood that patients with flexor hallucis tendon tears take longer to return to their pre-injury level of function. Our clinical experience refutes these reports and our study looks to further evaluate it.

This study brings back patients who were treated by the study doctor. The patient's preoperative evaluation will be reviewed including clinic notes and imaging. The operative reports for these patients will be reviewed to verify the surgery procedure performed. These patients will be included in the study and we will utilize the American Academy of Orthopedic Surgeons Foot, Ankle, and Lower Limb module that they have completed postoperatively. This measure of patient's functional and subjective satisfaction has already been completed by patients at their regularly scheduled follow up appointments and is available for review.

Prospectively, patients will be asked to return to the clinic for a follow-up evaluation, which includes a standard x-ray. All patients will be consented prior to data collection, minors included in this study will be asked to sign an assent as well. Many factors will be assessed such as; a range of motion test of the ankle utilizing goniometric technique, nerve path and function, stability ankle grading, radiologic findings, and patient-reported outcomes filled out pre and postoperatively.

Conditions

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Ankle Impingement Tendon Tear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Os Trigonum Excision with Tear

Participants with flexor hallucis tendon tear

Foot Exam Follow-Up

Intervention Type OTHER

All participants will have a clinical assessment of their surgery foot by the study doctor.

X-ray

Intervention Type RADIATION

Standard x-ray of the foot.

Questionnaire

Intervention Type OTHER

All participants will complete a questionnaire.

Os Trigonum Excision without Tear

Participants without flexor hallucis tendon tear

Foot Exam Follow-Up

Intervention Type OTHER

All participants will have a clinical assessment of their surgery foot by the study doctor.

X-ray

Intervention Type RADIATION

Standard x-ray of the foot.

Questionnaire

Intervention Type OTHER

All participants will complete a questionnaire.

Interventions

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Foot Exam Follow-Up

All participants will have a clinical assessment of their surgery foot by the study doctor.

Intervention Type OTHER

X-ray

Standard x-ray of the foot.

Intervention Type RADIATION

Questionnaire

All participants will complete a questionnaire.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Os trigonum excision with or without a flexor hallucis longus tear in an athletic population (recreational to competitive)
* Males and females ages 11-50 at time of surgery

Exclusion Criteria

* Any other injury that will affect their return to play or recovery process
* Individuals not actively involved in athletic sport/activity
* Pregnant women
* Any other concomitant injuries
Minimum Eligible Age

11 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forte Sports Medicine and Orthopedics

OTHER

Sponsor Role lead

Responsible Party

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David Porter

Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Porter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Forte Sports Medicine and Orthopedics

Locations

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Methodist Sports Medicine Carmel

Carmel, Indiana, United States

Site Status

Methodist Sports Medicine Greenwood

Greenwood, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1453238

Identifier Type: -

Identifier Source: org_study_id

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