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

Sponsor
Forte Sports Medicine and Orthopedics (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04467099
Collaborator
(none)
100
2
29
50
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Flexor Hallucis Longus Tears, Associated Os Trigonum Excision, and Return to Play
Actual Study Start Date :
Mar 2, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of flexor hallucis longus tears associated with os trigonum excision [Less than or equal to 30 days]

    How many participants had a tear.

Secondary Outcome Measures

  1. Length until return to play [Less than or equal to 30 days]

    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.

  2. Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle questionnaire [preoperative; perioperative; intraoperative; Less than or equal to 30 days]

    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.

  3. Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Lower Limb questionnaire [preoperative; perioperative; intraoperative; Less than or equal to 30 days]

    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.

  4. Change in foot and ankle nerve function [preoperative; perioperative; intraoperative; Less than or equal to 30 days]

    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.

  5. Change in foot and ankle areas of pain [preoperative; perioperative; intraoperative; Less than or equal to 30 days]

    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.

  6. Change in foot and ankle range of motion [preoperative; perioperative; intraoperative; Less than or equal to 30 days]

    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.

  7. Change in foot and ankle stability [preoperative; perioperative; intraoperative; Less than or equal to 30 days]

    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.

  8. Change in foot and ankle imaging for x-ray and magnetic resonance imaging [preoperative; perioperative; intraoperative; Less than or equal to 30 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Sports Medicine Carmel Carmel Indiana United States 46280
2 Methodist Sports Medicine Greenwood Greenwood Indiana United States 46142

Sponsors and Collaborators

  • Forte Sports Medicine and Orthopedics

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Porter, Orthopedic Surgeon, Forte Sports Medicine and Orthopedics
ClinicalTrials.gov Identifier:
NCT04467099
Other Study ID Numbers:
  • 1453238
First Posted:
Jul 10, 2020
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by David Porter, Orthopedic Surgeon, Forte Sports Medicine and Orthopedics

Study Results

No Results Posted as of Sep 20, 2021