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

NCT04467099 | Unknown DMC

• 1 other identifier: 1453238
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Ankle Impingement; Tendon Tear

Keywords

flexor hallucis longus; os trigonum; return to play

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Length until return to play

  Less than or equal to 30 days

• Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle questionnaire

  preoperative; perioperative; intraoperative; Less than or equal to 30 days

• Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Lower Limb questionnaire

  preoperative; perioperative; intraoperative; Less than or equal to 30 days

• Change in foot and ankle nerve function

  preoperative; perioperative; intraoperative; Less than or equal to 30 days

• Change in foot and ankle areas of pain

  preoperative; perioperative; intraoperative; Less than or equal to 30 days

Study Arms (2)

Os Trigonum Excision with Tear

Participants with flexor hallucis tendon tear

Other: Foot Exam Follow-Up; Radiation: X-ray; Other: Questionnaire

Os Trigonum Excision without Tear

Participants without flexor hallucis tendon tear

Other: Foot Exam Follow-Up; Radiation: X-ray; Other: Questionnaire

Interventions

Foot Exam Follow-Up OTHER

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

Os Trigonum Excision with Tear; Os Trigonum Excision without Tear

X-ray RADIATION

Standard x-ray of the foot.

Os Trigonum Excision with Tear; Os Trigonum Excision without Tear

Questionnaire OTHER

All participants will complete a questionnaire.

Os Trigonum Excision with Tear; Os Trigonum Excision without Tear

Eligibility Criteria

• Age: 11 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forte Sports Medicine and Orthopedics: lead

Study Sites (2)

Methodist Sports Medicine Carmel

Carmel, Indiana, 46280, United States

Location

Methodist Sports Medicine Greenwood

Greenwood, Indiana, 46142, United States

Location

MeSH Terms

Interventions

X-Rays; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• David Porter, MD, PhD

  Forte Sports Medicine and Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: July 10, 2020
• Study Start: March 2, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

US (2)