Talocalcaneal BarNCT05170698
Management of Pes Planovalgus With Talocalcaneal Coalition ,Osteotomy vs Arthroereisis
A study testing Coaltion excision and arthroereisis and Coalition excision and corrective osteotomies in people with Talocalcaneal Bar and Pes Planus, run by Ain Shams University at 1 site in Egypt.
Trial summary
the investigators compare the corrective osteotomies vs arthroereisis in management of talcalcaneal coalition in adolescents as regard the outcome to provide the best intervention for the patient Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Talocalcaneal Bar, Pes Planus
- What is being tested?
- Coaltion excision and arthroereisis and Coalition excision and corrective osteotomies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Nov 2018to 30 Dec 2021
- Phase
- Interventional
- 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 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- flat foot due to talocalcaneal coalition Symptomatic patient Resectable coalition Age between 10 and 20
Who cannot join
- flat foot of other etiology Age more than 20 Concurrent knee deformity unless corrected before surgery Extensive coalition more than 50 %of posterior facet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coalition Excision and Corrective Osteotomies vs Coalition Excision and Arthroereisis in Management of Pes Planovalgus With Talocalcaneal Coalition in Adolescent
the investigators compare the corrective osteotomies vs arthroereisis in management of talcalcaneal coalition in adolescents as regard the outcome to provide the best intervention for the patient
Read the detailed description
In talocalcaneal coalition management is controversial so in this study the invstigators try to compare techniques other than coalition excision only or fusion only by using two types of intervention including first coalition excision and multiple corrective osteotomies according to deformity as evans ,medial displacement calcaneal osteotomy and cotton osteotomy vs coalition excision and arthroereisis the investigators compare functional and radiological outcomes and complication to provide the best management for these patients .
- Conditions
- Talocalcaneal Bar, Pes Planus
- Being tested
- Coaltion excision and arthroereisis, Coalition excision and corrective osteotomies
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaltion excision and arthroereisisProcedure or surgery
Also called Coalition excision and corrective osteotomies
Both done to treat rigid flat foot with talocalcaneal coalition. Talocalcaneal coalition excision and management of rigid pes planovalgus in adolescent
Coalition excision and corrective osteotomiesProcedure or surgery
Both done to treat rigid flat foot with talocalcaneal coalition. Talocalcaneal coalition excision and management of rigid pes planovalgus in adolescent
| Study group | Role | What they receive |
|---|---|---|
| coalition excision and arthroereisis | Experimental | Talocalcaneal bar excision is done and then arthroereisis implant is applied in subtalar joint to correct rigid pes planovalgus in adolescent Receives: Procedure: Coaltion excision and arthroereisis |
| coalition excision and corrective osteotomies | Experimental | Talocalcaneal bar excision is done and then according to degree of deformity either medial displacement calcaneal osteotomy or evans or cotton osteotomy is done or combined together to correct rigid pes planovalgus in adolescents Receives: Procedure: Coalition excision and corrective osteotomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of deformity valgus
By goniometer
Measured: preoperative
Degree of deformity valgus
By goniometer
Measured: three months
Degree of deformity valgus
By goniometer
Measured: six months
Degree of deformity valgus
By goniometer
Measured: one year postoperative
Degree of deformity valgus
By goniometer
Measured: two year postoperative
Subtalar range of motion
By geniometer for inversion and eversion
Measured: preoperative
Subtalar range of motion
By geniometer for inversion and eversion
Measured: three months
Subtalar range of motion
By geniometer for inversion and eversion
Measured: six months
Subtalar range of motion
By geniometer for inversion and eversion
Measured: one year postoperative
Subtalar range of motion
By geniometer for inversion and eversion
Measured: two year postoperative
Secondary outcomes (10)
functional outcome
By foot ankle ability measurement score
Measured: preoperative
Patient satisfaction
By foot and ankle disability score
Measured: preoperative
functional outcome
By foot ankle ability measurement score
Measured: three months
Patient satisfaction
By foot and ankle disability score
Measured: three months
functional outcome
By foot ankle ability measurement score
Measured: six months
Patient satisfaction
By foot and ankle disability score
Measured: six months
functional outcome
By foot ankle ability measurement score
Measured: one year
functional outcome
By foot ankle ability measurement score
Measured: two year
Patient satisfaction
By foot and ankle disability score
Measured: one year
Patient satisfaction
By foot and ankle disability score
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start18 Nov 2018
- Primary completion18 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Talocalcaneal BarStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups one with the first intervention arthroereisis and bar excision the second with bar excision and osteotomies it may be one or multiple
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ayman m howeidy, professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170698
- Sponsor's protocol ID
- 0000017585
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Shazly O, Mokhtar M, Abdelatif N, Hegazy M, El Hilaly R, El Zohairy A, Tawfik E. Coalition resection and medial displacement calcaneal osteotomy for treatment of symptomatic talocalcaneal coalition: functional and clinical outcome. Int Orthop. 2014 Dec;38(12):2513-7. doi: 10.1007/s00264-014-2535-3. Epub 2014 Sep 25.
PubMed 25248861Siddiqui NA, Lamm BM. Digital planning for foot and ankle deformity correction: Evans osteotomy. J Foot Ankle Surg. 2014 Nov-Dec;53(6):700-5. doi: 10.1053/j.jfas.2014.04.011. Epub 2014 Jun 6.
PubMed 24909804
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coalition Excision and Corrective Osteotomies vs Coalition Excision and Arthroereisis in Management of Pes Planovalgus With Talocalcaneal Coalition in Adolescent
- ClinicalTrials.gov ID
- NCT05170698
- Acronym / sponsor ID
- 0000017585
- Conditions
- Talocalcaneal Bar, Pes Planus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 28 Dec 2021 (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 investigators compare the corrective osteotomies vs arthroereisis in management of talcalcaneal coalition in adolescents as regard the outcome to provide the best intervention for the patient
Detailed description
In talocalcaneal coalition management is controversial so in this study the invstigators try to compare techniques other than coalition excision only or fusion only by using two types of intervention including first coalition excision and multiple corrective osteotomies according to deformity as evans ,medial displacement calcaneal osteotomy and cotton osteotomy vs coalition excision and arthroereisis the investigators compare functional and radiological outcomes and complication to provide the best management for these patients .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2 groups one with the first intervention arthroereisis and bar excision the second with bar excision and osteotomies it may be one or multiple
| Arm | Type | Receives |
|---|---|---|
| coalition excision and arthroereisis | Experimental | Procedure: Coaltion excision and arthroereisisTalocalcaneal bar excision is done and then arthroereisis implant is applied in subtalar joint to correct rigid pes planovalgus in adolescent |
| coalition excision and corrective osteotomies | Experimental | Procedure: Coalition excision and corrective osteotomiesTalocalcaneal bar excision is done and then according to degree of deformity either medial displacement calcaneal osteotomy or evans or cotton osteotomy is done or combined together to correct rigid pes planovalgus in adolescents |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- flat foot due to talocalcaneal coalition Symptomatic patient Resectable coalition Age between 10 and 20
Key exclusion criteria (1 listed)
- flat foot of other etiology Age more than 20 Concurrent knee deformity unless corrected before surgery Extensive coalition more than 50 %of posterior facet
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 |
|---|---|---|
| Coaltion excision and arthroereisisAlso: Coalition excision and corrective osteotomiesBoth done to treat rigid flat foot with talocalcaneal coalition. Talocalcaneal coalition excision and management of rigid pes planovalgus in adolescent | Procedure or surgery | coalition excision and arthroereisis |
| Coalition excision and corrective osteotomiesBoth done to treat rigid flat foot with talocalcaneal coalition. Talocalcaneal coalition excision and management of rigid pes planovalgus in adolescent | Procedure or surgery | coalition excision and corrective osteotomies |
Primary outcome
Degree of deformity valgus
Time frame: preoperative
By goniometer
Degree of deformity valgus
Time frame: three months
By goniometer
Degree of deformity valgus
Time frame: six months
By goniometer
Degree of deformity valgus
Time frame: one year postoperative
By goniometer
Degree of deformity valgus
Time frame: two year postoperative
By goniometer
Subtalar range of motion
Time frame: preoperative
By geniometer for inversion and eversion
Subtalar range of motion
Time frame: three months
By geniometer for inversion and eversion
Subtalar range of motion
Time frame: six months
By geniometer for inversion and eversion
Subtalar range of motion
Time frame: one year postoperative
By geniometer for inversion and eversion
Subtalar range of motion
Time frame: two year postoperative
By geniometer for inversion and eversion
10 secondary outcomes
functional outcome
Time frame: preoperative
Patient satisfaction
Time frame: preoperative
functional outcome
Time frame: three months
Patient satisfaction
Time frame: three months
functional outcome
Time frame: six months
Patient satisfaction
Time frame: six months
functional outcome
Time frame: one year
functional outcome
Time frame: two year
Patient satisfaction
Time frame: one year
Patient satisfaction
Time frame: two year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Background: PubMed 25248861El Shazly O, Mokhtar M, Abdelatif N, Hegazy M, El Hilaly R, El Zohairy A, Tawfik E. Coalition resection and medial displacement calcaneal osteotomy for treatment of symptomatic talocalcaneal coalition: functional and clinical outcome. Int Orthop. 2014 Dec;38(12):2513-7. doi: 10.1007/s00264-014-2535-3. Epub 2014 Sep 25.
- Background: PubMed 24909804Siddiqui NA, Lamm BM. Digital planning for foot and ankle deformity correction: Evans osteotomy. J Foot Ankle Surg. 2014 Nov-Dec;53(6):700-5. doi: 10.1053/j.jfas.2014.04.011. Epub 2014 Jun 6.
- Individual participant dataSharing planned: No
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.
ayman m howeidy, professor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaltion excision and arthroereisis and Coalition excision and corrective osteotomies in people with Talocalcaneal Bar and Pes Planus, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of deformity valgus (time frame: preoperative). The study lists 10 primary outcomes in all. 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 NCT05170698, which also lists 2 linked publications.
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 3 Jun 2022.