An observational study in Ankle Impingement and Tendon Tear, sponsored by Forte Sports Medicine and Orthopedics. Status unknown at 2 sites in United States. Open to participants aged 11 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-09-20.
Sponsored by Forte Sports Medicine and Orthopedics · Observational
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.
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.
Forte Sports Medicine and Orthopedics is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Participants with flexor hallucis tendon tear
Other: Foot Exam Follow-Up · Radiation: X-ray · Other: Questionnaire
Participants without flexor hallucis tendon tear
Other: Foot Exam Follow-Up · Radiation: X-ray · Other: Questionnaire
All participants will have a clinical assessment of their surgery foot by the study doctor.
Standard x-ray of the foot.
All participants will complete a questionnaire.
Incidence of flexor hallucis longus tears associated with os trigonum excision
How many participants had a tear.
Time frame: Less than or equal to 30 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Forte Sports Medicine and Orthopedics