Subtalar Osteoarthritis Secondary to Inflammatory ArthritisNCT05795543
Subtalar Arthrodesis by Single Versus Double Screws
A study testing Subtalar Arthrodesis by Screws in people with Subtalar Osteoarthritis Secondary to Inflammatory Arthritis, run by Assiut University.
Trial summary
Compare clinical and radiological outcome of use of single screw versus double screws fixation for subtalar arthrodesis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subtalar Osteoarthritis Secondary to Inflammatory Arthritis
- What is being tested?
- Subtalar Arthrodesis by Screws
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who will be operated by subtalar fusion for any indication Age range 18 - 65
Who cannot join
- Age < 18 years , > 65 Acute calceneal fracture Infection Non union Bone defect that need bone graft Refusing to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Single Versus Double Screws Fixation of Subtalar Arthrodesis : A Prospective Randomized Controlled Study
Compare clinical and radiological outcome of use of single screw versus double screws fixation for subtalar arthrodesis
Read the detailed description
The subtalar joint consists of an anterior, posterior and medial joint facet, which allows for inversion - and eversion of the foot. Several pathologies may lead to pain originating from the subtalar joint, including primary arthritis, posttraumatic arthritis, congenital or acquired deformities, instability, tarsal coalition or inflammatory diseases Management of these pathologies variable including conservative and operative treatment once conservative treatment has failed subtalar fusion is a common surgical procedure which is a well-established and widely accepted There are many surgical techniques described for fusion , one of these techniques is fixation with screws The rate of non-union varies among authors between 0-46%, that's may due to lack of standardization of techniques should be used
- Being tested
- Subtalar Arthrodesis by Screws
- Keywords
- subtalar arthrodesis, screws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtalar Arthrodesis by ScrewsProcedure or surgery
Instruments: cannulated screws Steps: supine position , tournique over the thigh, using a extended lateral approach or sinus tarsi approach with joint debridement and preparation. Single-screw fixation was most often placed from posterior to anterior and double screws fixation was placed triangular pattern
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | subtalar arthrodesis by single screw Receives: Procedure: Subtalar Arthrodesis by Screws |
| B | Active comparator | subtalar arthrodesis by double screws Receives: Procedure: Subtalar Arthrodesis by Screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion rate
subtalar fusion radiologically and clinically
Measured: 3 month
Secondary outcomes (1)
Functional assessment -rate of complications(e.g. non-union, post-operative infections, Instability) -secondary surgery procedures
by AOFAS Ankle-Hindfoot Scale
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
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 Subtalar Osteoarthritis Secondary to Inflammatory ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- participant divide to 2 groups first group subtalar arthrodesis by single screw second group subtalar arthrodesis by double screws
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud moustafa khalafallah ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795543
- Sponsor's protocol ID
- subtalar arthrodesis
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wirth SH, Viehofer A, Fritz Y, Zimmermann SM, Rigling D, Urbanschitz L. How many screws are necessary for subtalar fusion? A retrospective study. Foot Ankle Surg. 2020 Aug;26(6):699-702. doi: 10.1016/j.fas.2019.08.017. Epub 2019 Sep 6.
PubMed 31522872Buch BD, Myerson MS, Miller SD. Primary subtaler arthrodesis for the treatment of comminuted calcaneal fractures. Foot Ankle Int. 1996 Feb;17(2):61-70. doi: 10.1177/107110079601700202.
PubMed 8919403
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Double Screws Fixation of Subtalar Arthrodesis : A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05795543
- Acronym / sponsor ID
- subtalar arthrodesis
- Keywords
- subtalar arthrodesis, screws
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Apr 2023 (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 clinical and radiological outcome of use of single screw versus double screws fixation for subtalar arthrodesis
Detailed description
The subtalar joint consists of an anterior, posterior and medial joint facet, which allows for inversion - and eversion of the foot. Several pathologies may lead to pain originating from the subtalar joint, including primary arthritis, posttraumatic arthritis, congenital or acquired deformities, instability, tarsal coalition or inflammatory diseases Management of these pathologies variable including conservative and operative treatment once conservative treatment has failed subtalar fusion is a common surgical procedure which is a well-established and widely accepted There are many surgical techniques described for fusion , one of these techniques is fixation with screws The rate of non-union varies among authors between 0-46%, that's may due to lack of standardization of techniques should be used
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participant divide to 2 groups first group subtalar arthrodesis by single screw second group subtalar arthrodesis by double screws
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Subtalar Arthrodesis by Screwssubtalar arthrodesis by single screw |
| B | Active comparator | Procedure: Subtalar Arthrodesis by Screwssubtalar arthrodesis by double screws |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who will be operated by subtalar fusion for any indication Age range 18 - 65
Key exclusion criteria (1 listed)
- Age < 18 years , > 65 Acute calceneal fracture Infection Non union Bone defect that need bone graft Refusing to participate in the study
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 |
|---|---|---|
| Subtalar Arthrodesis by ScrewsInstruments: cannulated screws Steps: supine position , tournique over the thigh, using a extended lateral approach or sinus tarsi approach with joint debridement and preparation. Single-screw fixation was most often placed from posterior to anterior and double screws fixation was placed triangular pattern | Procedure or surgery | A, B |
Primary outcome
Fusion rate
Time frame: 3 month
subtalar fusion radiologically and clinically
1 secondary outcome
Functional assessment -rate of complications(e.g. non-union, post-operative infections, Instability) -secondary surgery procedures
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 31522872Wirth SH, Viehofer A, Fritz Y, Zimmermann SM, Rigling D, Urbanschitz L. How many screws are necessary for subtalar fusion? A retrospective study. Foot Ankle Surg. 2020 Aug;26(6):699-702. doi: 10.1016/j.fas.2019.08.017. Epub 2019 Sep 6.
- Background: PubMed 8919403Buch BD, Myerson MS, Miller SD. Primary subtaler arthrodesis for the treatment of comminuted calcaneal fractures. Foot Ankle Int. 1996 Feb;17(2):61-70. doi: 10.1177/107110079601700202.
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?
A study testing Subtalar Arthrodesis by Screws in people with Subtalar Osteoarthritis Secondary to Inflammatory Arthritis, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 3 Apr 2023. 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 M khalafallah, master (01117513794, Mahmoud.20134334@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion rate (time frame: 3 month). 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 NCT05795543, 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 Apr 2023.