Ankle ImpingementNCT04467099
Prevalence of Flexor Hallucis Longus Tears, Associated Os Trigonum Excision, and Return to Play
An observational study of Ankle Impingement and Tendon Tear, run by Forte Sports Medicine and Orthopedics at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 11 to 50 years
- Conditions the study is for
- Ankle Impingement, Tendon Tear
- What is being tested?
- Foot Exam Follow-Up, X-ray and Questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Mar 2020to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Methodist Sports Medicine Carmel
Carmel, Indiana, 46280
Methodist Sports Medicine Greenwood
Greenwood, Indiana, 46142
About this study
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.
Read the 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.
- Conditions
- Ankle Impingement, Tendon Tear
- Being tested
- Foot Exam Follow-Up, X-ray, Questionnaire
- Keywords
- flexor hallucis longus, os trigonum, return to play
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Exam Follow-UpOther
All participants will have a clinical assessment of their surgery foot by the study doctor.
X-rayRadiation
Standard x-ray of the foot.
QuestionnaireOther
All participants will complete a questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Os Trigonum Excision with Tear | Participants with flexor hallucis tendon tear Receives: Other: Foot Exam Follow-Up; Radiation: X-ray; Other: Questionnaire | |
| Os Trigonum Excision without Tear | Participants without flexor hallucis tendon tear Receives: Other: Foot Exam Follow-Up; Radiation: X-ray; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of flexor hallucis longus tears associated with os trigonum excision
How many participants had a tear.
Measured: Less than or equal to 30 days
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: preoperative; perioperative; intraoperative; Less than or equal to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start2 Mar 2020
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forte Sports Medicine and Orthopedics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Porter, Forte Sports Medicine and Orthopedics
- Investigators
- David Porter, MD, PhD, Principal investigator, Forte Sports Medicine and Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467099
- Sponsor's protocol ID
- 1453238
- Status last verified
- Sep 2021
- First submitted
- 17 Jun 2020
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Flexor Hallucis Longus Tears, Associated Os Trigonum Excision, and Return to Play
- ClinicalTrials.gov ID
- NCT04467099
- Acronym / sponsor ID
- 1453238
- Conditions
- Ankle Impingement, Tendon Tear
- Keywords
- flexor hallucis longus, os trigonum, return to play
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Forte Sports Medicine and OrthopedicsUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Os Trigonum Excision with Tear | – | Other: Foot Exam Follow-Up, Radiation: X-ray, Other: QuestionnaireParticipants with flexor hallucis tendon tear |
| Os Trigonum Excision without Tear | – | Other: Foot Exam Follow-Up, Radiation: X-ray, Other: QuestionnaireParticipants without flexor hallucis tendon tear |
Who may qualify
- Ages
- 11 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot Exam Follow-UpAll participants will have a clinical assessment of their surgery foot by the study doctor. | Other | Os Trigonum Excision with Tear, Os Trigonum Excision without Tear |
| X-rayStandard x-ray of the foot. | Radiation | Os Trigonum Excision with Tear, Os Trigonum Excision without Tear |
| QuestionnaireAll participants will complete a questionnaire. | Other | Os Trigonum Excision with Tear, Os Trigonum Excision without Tear |
Primary outcome
Incidence of flexor hallucis longus tears associated with os trigonum excision
Time frame: Less than or equal to 30 days
How many participants had a tear.
8 secondary outcomes
Length until return to play
Time frame: Less than or equal to 30 days
Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle questionnaire
Time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Lower Limb questionnaire
Time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
Change in foot and ankle nerve function
Time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
Change in foot and ankle areas of pain
Time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
Change in foot and ankle range of motion
Time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
Change in foot and ankle stability
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
Time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Porter, MD, PhD principal investigator
Forte Sports Medicine and Orthopedics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Impingement and Tendon Tear, run by Forte Sports Medicine and Orthopedics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of flexor hallucis longus tears associated with os trigonum excision (time frame: Less than or equal to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.