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

Sponsor
Mahmoud Ali Hassan Abdelhamid (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05475626
Collaborator
(none)
50
Enrollment
21
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis- A Randomised Controlled Study
Anticipated Study Start Date :
Aug 30, 2022
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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) [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.

Secondary Outcome Measures

  1. ): to detect the radiographic measurments change between the surgical treatment of symptomatic pes planus by sinus tarsi screw versus conical subtalar arthroerasis [1 year]

    RadiologicalEvaluation(AP&lateral)withangleevaluation:Radiographswillbe takenpreoperatively,directlypostoperatively,andatmidtermfollow-upina weight-bearingstandingposition.Thecalcanealpitch(CP)andMeary'sangle (MA;alsoreferredtoaslateraltalo-firstmetatarsalangle)willbeusedto determinefootanatomy

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mahmoud Ali Hassan Abdelhamid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Mahmoud Ali Hassan Abdelhamid, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05475626
Other Study ID Numbers:
  • Randomized controlled study
First Posted:
Jul 27, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Flatfoot

Study Results

No Results Posted as of Jul 27, 2022