Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis

July 23, 2022 updated by: Mahmoud Ali Hassan Abdelhamid

Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis- A Randomised Controlled Study

compare the outcome of surgical treatment planus by sinus tarsi screw versus conical subtalar screw arthroereisis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pes planus occurs as a result of loss of the medial longitudinal arch, abduction of the forefoot and excessive subtalar eversion. It can broadly be categorized as rigid or flexible.(1) Flexible pes planus has no single identifiable cause and is often asymptomatic.(1-3) Patients with pesplanus had a very tight achilles tendon due to compensatory motion.(4) It can become painful and may require orthopaedic or pediatric intervention. Common treatment modalities include rest, physiotherapy, orthotics and anti-inflammatories.(1,3,5-6) Surgery is uncommon unless pain persists in spite of nonsurgical management.(5-6) Surgical options include soft tissue procedures, realignment osteotomies and non-fusion motion-limiting techniques.(1,2,6-9) Fusion of selected joints in the foot is not recommended in paediatric patients unless associated with a neuromuscular pathology.(1,5) Subtalar arthroereisis is a recognized non-fusion surgical treatment for symptomatic paediatric flexible pes planus. Arthroereisis (also arthroreisis, arthrorhisis or arthrorisis) derives from Greek, translated as to prop up or support a joint.(10) When Flexible pes planus becomes symptomatic, affecting gait and limiting quality of life, and conservative treatment such as weight reduction, physiotherapy or insoles fail, operative treatment can be considered .(7) There are two techniques for subtalar arthroereisis: (11) Insertion of an implant directly into the sinus tarsi to prevent it collapsing down. (10) Screw insertion into the lateral side of either the talus or calcaneus(12). Calcaneo-stop method with cancellous screw insertion into sinus tarsi for subtalar arthroresis is a valid procedure for this multiplanar deformity. Maintaince of correction of the deformity is achieved via a prioprioceptive mechanism. (13) The current research is the first one to compare the clinical , radiological,and patient satisfaction outcome of planovalgus cases treated with two different types of subtalar arthroereisis implants . The purpose of this prospective study is to show the best technique to achieve patient satisfaction.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients above the ages of 7years

• All patients with symptomatic pes planus

Description

Inclusion Criteria:

- Patients are eligible for participation in the study if

  • Patients above the ages of 7years
  • All patients with symptomatic pes planus
  • flexible flat feet
  • Not respond to conservative therapies.

Exclusion Criteria:

  • Patients are excluded for participation in the study if

    • Patients were age < 7 years
    • Asymptomatic patient
    • Rigid flat feet
    • Unfit for surgery
    • Children with neuromuscular diseases, post traumatic or congenital pes planovalgus will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw
Treatment Of Symptomatic Pes Planus
Procedure: Arthroereisis-
Surgical options include soft tissue procedures, realignment osteotomies and non-fusion motion-limiting techniques.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
to identify and evaluate the comparison between two technical procedure of surgical treatment of symptomatic pes planus by sinus tarsi screw versus conical subtalar screw arthroerasis using American Orthopaedic Foot and Ankle Society scores (AOFAS)
Time Frame: 2 years
American Orthopedic Foot & Ankle Society (AOFAS) ankle-hind foot score was assessed. The total AOFAS score 100 points divided to 40 points for assessment of pain, 50 points for the functional assessment " activity limitations, maximum walking distance, gait abnormality…etc" and 10 points for assessment of the alignment.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
): to detect the radiographic measurments change between the surgical treatment of symptomatic pes planus by sinus tarsi screw versus conical subtalar arthroerasis
Time Frame: 1 year
RadiologicalEvaluation(AP&lateral)withangleevaluation:Radiographswillbe takenpreoperatively,directlypostoperatively,andatmidtermfollow-upina weight-bearingstandingposition.Thecalcanealpitch(CP)andMeary'sangle (MA;alsoreferredtoaslateraltalo-firstmetatarsalangle)willbeusedto determinefootanatomy
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahmoud Ali Hassan Abdelhamid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Carr JB II, Yang S, Lather LA. Pediatric pes planus: a state-of-the-art review.Pediatrics 2016;137:e20151230. 2. Dare DM, Dodwell ER. Pediatric flatfoot: cause, epidemiology, assessment, and treatment. Curr Opin Pediatr 2014;26:93-100. 3. Mosca VS. Flexible flatfoot in children and adolescents. J Child Orthop 10;4:107-121. 4. Raj MA, Tafti D, Kiel J. Pes Planus (Flat Feet). StatPearl-NCBI Bookshelf, 2020. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430802/ (Accessed 29 June 2020) 5.Sheikh Taha AM, Feldman DS. Painful flexible flatfoot. Foot Ankle Clin 2015;20:693-704. 6. Bouchard M, Mosca VS. Flatfoot deformity in children and adolescents: surgical indications and management. J Am Acad Orthop Surg 2014;22:623-632. 7. Walters JL, Mendicino SS. Flexible adult flatfoot: soft tissue procedures. Clin Podiatr Med Surg 2014;31:349-355. 8. Peterson KS, Overley BD Jr, Beideman TC. Osteotomies for the flexible adult acquired flatfoot disorder. Clin Podiatr Med Surg 2015;32:389-403. 9. Abubeih ,Hossam MA.,Wael El-Adly ,and Kotb,M.M. Modified calcaneo-stop screw method for treatment of symptomatic pediatric flexible flatfoot deformity . Current Orthopaedic Practice 26.6 (2015);614-618. 10. Medical Dictionary. Arthroereisis. The Free Dictionary. https://medical-dictionary. The free dictionary .com/arthroereisis (date last accessed 5 July 2018). 11. Chambers EF. An operation for the correction of flexible flat feet of adolescents. West J Surg Obstet Gynecol 1946;54:77-86. 12. Shah NS, Needleman RL, Bokhari O, Buzas D. 2013 subtalar arthroereisis survey: the current practice patterns of members of the AOFAS. Foot Ankle Spec 2015;8: 180-185 13. Staheli L. Planovalgus foot deformity.Current status.Journal of the American Podiatric Medical Association 1999;89(2): 94-9. 14. Ritchie GW and Keim HA .A radiographic analysis of major foot deformities.Canad Med Ass J Oct 1963;Vol 91 .

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Randomized controlled study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis- A Randomised Controlled Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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