Symptomatic Flexible Flat FeetNCT05475626
Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis
An observational study of Symptomatic Flexible Flat Feet, run by Mahmoud Ali Hassan Abdelhamid.
Trial summary
compare the outcome of surgical treatment planus by sinus tarsi screw versus conical subtalar screw arthroereisis Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Symptomatic Flexible Flat Feet
- What is being tested?
- Arthroereisis-
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2022to 30 May 2024
- How long will I take part?
- 2 Years
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients above the ages of 7years • All patients with symptomatic pes planus
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Symptomatic Flexible Flat Feet
- Being tested
- Arthroereisis-
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroereisis-Procedure or surgery
Surgical options include soft tissue procedures, realignment osteotomies and non-fusion motion-limiting techniques.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw | Treatment Of Symptomatic Pes Planus Receives: Procedure: Arthroereisis- |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 2 years
Secondary outcomes (1)
): to detect the radiographic measurments change between the surgical treatment of symptomatic pes planus by sinus tarsi screw versus conical subtalar arthroerasis
RadiologicalEvaluation(AP\&lateral)withangleevaluation:Radiographswillbe takenpreoperatively,directlypostoperatively,andatmidtermfollow-upina weight-bearingstandingposition.Thecalcanealpitch(CP)andMeary'sangle (MA;alsoreferredtoaslateraltalo-firstmetatarsalangle)willbeusedto determinefootanatomy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start30 Aug 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Flexible Flat FeetStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mahmoud Ali Hassan Abdelhamid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Ali Hassan Abdelhamid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475626
- Sponsor's protocol ID
- Randomized controlled study
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis- A Randomised Controlled Study
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 .
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis- A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05475626
- Acronym / sponsor ID
- Randomized controlled study
- Conditions
- Symptomatic Flexible Flat Feet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mahmoud Ali Hassan AbdelhamidUniversity, hospital or other
- Study start
- 30 Aug 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 27 Jul 2022 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw | – | Procedure: Arthroereisis-Treatment Of Symptomatic Pes Planus |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients above the ages of 7years • All patients with symptomatic pes planus
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients are excluded for participation in the study if
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 |
|---|---|---|
| Arthroereisis-Surgical options include soft tissue procedures, realignment osteotomies and non-fusion motion-limiting techniques. | Procedure or surgery | Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw |
Primary outcome
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.
1 secondary outcome
): 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- BackgroundCarr 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 .
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Treatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw Arthroereisis- A Randomised Controlled Study
Related trials for Symptomatic Flexible Flat Feet
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Flexible Flat Feet, run by Mahmoud Ali Hassan Abdelhamid.
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 5 inclusion and 6 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact mahmoud ali, master (01093192729, mahmoudali203@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05475626, which also lists 1 linked publication.
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 27 Jul 2022.