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

Tendon Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04467099
• Other study ID #: 1453238
• Status: Enrolling by invitation
• Start date: March 2, 2020
• Est. completion date: August 2022

Study information

• Verified date: September 2021
• Source: Methodist Sports Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Impingement
• Tendon Tear

Intervention

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.

Locations

Country	Name	City	State
United States	Methodist Sports Medicine Carmel	Carmel	Indiana
United States	Methodist Sports Medicine Greenwood	Greenwood	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Sports Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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