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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tendon Tear; Ankle Impingement
• Intervention / Treatment: Other: Foot Exam Follow-Up; Radiation: X-ray; Other: Questionnaire

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46280
      • Methodist Sports Medicine Carmel
    • Greenwood, Indiana, United States, 46142
      • Methodist Sports Medicine Greenwood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Prior patients of the study doctor from August 1996 to June 2017 that underwent os trigonum excision and of the athletic population (recreational to competitive).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Os Trigonum Excision with Tear; Participants with flexor hallucis tendon tear	Other: Foot Exam Follow-Up; All participants will have a clinical assessment of their surgery foot by the study doctor.; Radiation: X-ray; Standard x-ray of the foot.; Other: Questionnaire; All participants will complete a questionnaire.
Os Trigonum Excision without Tear; Participants without flexor hallucis tendon tear	Other: Foot Exam Follow-Up; All participants will have a clinical assessment of their surgery foot by the study doctor.; Radiation: X-ray; Standard x-ray of the foot.; Other: Questionnaire; All participants will complete a questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of flexor hallucis longus tears associated with os trigonum excision	How many participants had a tear.	Less than or equal to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length until return to play	Comparing the length until return to play of the patients who had flexor hallucis longus tears with concomitant os trigonum excision versus those without flexor hallucis longus tears who underwent os trigonum excision.	Less than or equal to 30 days
Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle questionnaire	The questionnaire responses will be summarized and compared between os trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using two-sample Student t-tests.	preoperative; perioperative; intraoperative; Less than or equal to 30 days
Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Lower Limb questionnaire	The questionnaire responses will be summarized and compared between os trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using two-sample Student t-tests.	preoperative; perioperative; intraoperative; Less than or equal to 30 days
Change in foot and ankle nerve function	The comparison includes but is not limited to patient nerve path and function. The findings will be summarized and compared between os trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using chi-square tests or Fisher's exact tests.	preoperative; perioperative; intraoperative; Less than or equal to 30 days
Change in foot and ankle areas of pain	The comparison includes but is not limited to posterior pain, plantarflexion pain, os trigonum resection site pain, and other areas of pain upon visit. The findings will be summarized and compared between trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using chi-square tests or Fisher's exact tests.	preoperative; perioperative; intraoperative; Less than or equal to 30 days
Change in foot and ankle range of motion	The comparison includes but is not limited to patient range of motion (ROM) test in degrees of the ankle by assessing plantarflexion, dorsiflexion, hindfoot angle, and subtalar motion. The findings will be summarized and compared between trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using two-sample Student t-tests.	preoperative; perioperative; intraoperative; Less than or equal to 30 days
Change in foot and ankle stability	The comparison includes but is not limited to patient range of motion (ROM) test of the ankle by assessing plantarflexion, dorsiflexion, hindfoot angle, and subtalar motion. The findings will be summarized and compared between trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using chi-square tests or Fisher's exact tests.	preoperative; perioperative; intraoperative; Less than or equal to 30 days
Change in foot and ankle imaging for x-ray and magnetic resonance imaging	The comparison includes but is not limited to how many patients have within and group differences in x-ray and magnetic resonance imaging (MRI). Changes to be compared will include but not limited to ankle alignment, os trigonum, the appearance of posterior talus, osteochondral lesions, fractures or dislocations, stress fractures, plantar and posterior heel spurs and arthritic changes in the ankle or hindfoot.	preoperative; perioperative; intraoperative; Less than or equal to 30 days

Collaborators and Investigators

• Sponsor: Forte Sports Medicine and Orthopedics
• Investigators: Principal Investigator: David Porter, MD, PhD, Forte Sports Medicine and Orthopedics

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: return to play; flexor hallucis longus; os trigonum
• Other Study ID Numbers: 1453238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No