Clinical trial NCT05475626: Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis
Official title: Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis- A Randomised Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Symptomatic Flexible Flat Feet
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients above the ages of 7years

• All patients with symptomatic pes planus

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 2 years
Secondary outcomes:
measure: ): to detect the radiographic measurments change between the surgical treatment of symptomatic pes planus by sinus tarsi screw versus conical subtalar arthroerasis
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: 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 .