Acute Pediatric Septic Hip InfectionNCT06505720
Use of Arthroscopy in Treatment of Acute Pediatric Septic Hip Infection
A study testing Arthroscopic management of acute pediatric septic hip infecion and Open debridement of acute pediatric septic hip in people with Acute Pediatric Septic Hip Infection, run by Hesham Mohamed Elbaseet.
Trial summary
Acute septic hip infection in pediatric population is a true orthopedic surgical emergency that require early diagnosis and prompt management. Open surgical debridement and drainage of the hip through lateral approach is the gold standard method of treatment. Read more about this study
- Who is it for?
- Ages 10 months to 14 years
- Conditions the study is for
- Acute Pediatric Septic Hip Infection
- What is being tested?
- Arthroscopic management of acute pediatric septic hip infecion and Open debridement of acute pediatric septic hip
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 13 Aug 2024to 12 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 10 months - 14 years _unilateral or bilateral acute septic hip arthritis
Who cannot join
- Children with pre-existing other pathology of the affected hip, whether he / she has surgery for management of this pathology or not.
- Patients whose parents refuse to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Arthroscopic Versus Open Management of Acute Pediatric Septic Hip Infection: A Randomized Controlled Trial
Acute septic hip infection in pediatric population is a true orthopedic surgical emergency that require early diagnosis and prompt management. Open surgical debridement and drainage of the hip through lateral approach is the gold standard method of treatment. Usage of hip arthroscopy in the treatment of such condition has been in clinical practice for more than 30 years. However, literature is still lacking in actual prospective comparison about the outcome of both methods.
Read the detailed description
The study will divide the children presented with acute septic hip infection into two groups; the control group in which the child will undergo traditional open surgical debridement and drainage of the hip via lateral approach, and the intervention group in which arthroscopic drainage and debridement of the hip will be done. The outcomes of both methods will be recorded and compared. The research hypothesis is that arthroscopic management of acute pediatric septic hip infection is as effective as open surgery; with fewer complications and faster recovery.
- Conditions
- Acute Pediatric Septic Hip Infection
- Being tested
- Arthroscopic management of acute pediatric septic hip infecion, Open debridement of acute pediatric septic hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic management of acute pediatric septic hip infecionProcedure or surgery
Three-portals tractionless hip arthroscopy will be used to treat acute pediatric septic hip infection
Open debridement of acute pediatric septic hipProcedure or surgery
surgical drainage and debridement of acute septic hip in children via classic lateral approach
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | The child in this group will be treated for his\ her acute septic hip infection using open surgery ( The Standard Method) Receives: Procedure: Open debridement of acute pediatric septic hip |
| Intervention Group | Other | The child in this group will be treated for his\ her acute septic hip infection arthroscopically Receives: Procedure: Arthroscopic management of acute pediatric septic hip infecion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Mckay's criteria
Excellent: painless, stable hip; no limp; more than 15 degrees of internal rotation.
Good: painless, stable hip; slight limb or decreased motion , negative Trendelenburg sign Fair: minimum pain; moderate stiffness, positive Trendelenburg sign Poor: significant pain.
Measured: One Year Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start13 Aug 2024 (estimated)
- Primary completion12 Feb 2026 (estimated)
- Study completion12 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Pediatric Septic Hip InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hesham Mohamed Elbaseet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hesham Mohamed Elbaseet, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505720
- Sponsor's protocol ID
- ٍSeptic Hip in childern
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fabry G, Meire E. Septic arthritis of the hip in children: poor results after late and inadequate treatment. J Pediatr Orthop. 1983 Sep;3(4):461-6. doi: 10.1097/01241398-198309000-00008.
PubMed 6630490Sucato DJ, Schwend RM, Gillespie R. Septic Arthritis of the Hip in Children. J Am Acad Orthop Surg. 1997 Oct;5(5):249-260. doi: 10.5435/00124635-199709000-00003.
PubMed 10795061Kocher MS, Mandiga R, Zurakowski D, Barnewolt C, Kasser JR. Validation of a clinical prediction rule for the differentiation between septic arthritis and transient synovitis of the hip in children. J Bone Joint Surg Am. 2004 Aug;86(8):1629-35. doi: 10.2106/00004623-200408000-00005.
PubMed 15292409Shaw BA, Kasser JR. Acute septic arthritis in infancy and childhood. Clin Orthop Relat Res. 1990 Aug;(257):212-25.
PubMed 2199119DeAngelis NA, Busconi BD. Hip arthroscopy in the pediatric population. Clin Orthop Relat Res. 2003 Jan;(406):60-3. doi: 10.1097/01.blo.0000043044.84315.90.
PubMed 12579000Ellis HB, Copley L, Pennock A, Nepple JJ, Willimon C, Mayer SW, Yen YM. Tractionless Hip Arthroscopy for Septic Arthritis in Children. Arthrosc Tech. 2021 Feb 19;10(3):e659-e667. doi: 10.1016/j.eats.2020.10.079. eCollection 2021 Mar.
PubMed 33738199El-Sayed AM. Treatment of early septic arthritis of the hip in children: comparison of results of open arthrotomy versus arthroscopic drainage. J Child Orthop. 2008 Jun;2(3):229-37. doi: 10.1007/s11832-008-0094-0. Epub 2008 Mar 6.
PubMed 19308583Bennett OM, Namnyak SS. Acute septic arthritis of the hip joint in infancy and childhood. Clin Orthop Relat Res. 1992 Aug;(281):123-32.
PubMed 1499198Donders CM, Spaans AJ, Bessems JHJM, van Bergen CJA. A systematic review of the optimal drainage technique for septic hip arthritis in children. Hip Int. 2022 Sep;32(5):685-693. doi: 10.1177/1120700021989666. Epub 2021 Feb 10.
PubMed 33566696McKay DW. A comparison of the innominate and the pericapsular osteotomy in the treatment of congenital dislocation of the hip. Clin Orthop Relat Res. 1974 Jan-Feb;(98):124-32. doi: 10.1097/00003086-197401000-00013. No abstract available.
PubMed 4817221
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Versus Open Management of Acute Pediatric Septic Hip Infection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06505720
- Acronym / sponsor ID
- ٍSeptic Hip in childern
- Conditions
- Acute Pediatric Septic Hip Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hesham Mohamed ElbaseetUniversity, hospital or other
- Study start
- 13 Aug 2024 (estimated)
- Primary completion
- 12 Feb 2026 (estimated)
- Study completion
- 12 Feb 2027 (estimated)
- First posted
- 17 Jul 2024 (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.
Acute septic hip infection in pediatric population is a true orthopedic surgical emergency that require early diagnosis and prompt management. Open surgical debridement and drainage of the hip through lateral approach is the gold standard method of treatment. Usage of hip arthroscopy in the treatment of such condition has been in clinical practice for more than 30 years. However, literature is still lacking in actual prospective comparison about the outcome of both methods.
Detailed description
The study will divide the children presented with acute septic hip infection into two groups; the control group in which the child will undergo traditional open surgical debridement and drainage of the hip via lateral approach, and the intervention group in which arthroscopic drainage and debridement of the hip will be done. The outcomes of both methods will be recorded and compared. The research hypothesis is that arthroscopic management of acute pediatric septic hip infection is as effective as open surgery; with fewer complications and faster recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Procedure: Open debridement of acute pediatric septic hipThe child in this group will be treated for his\ her acute septic hip infection using open surgery ( The Standard Method) |
| Intervention Group | Other | Procedure: Arthroscopic management of acute pediatric septic hip infecionThe child in this group will be treated for his\ her acute septic hip infection arthroscopically |
Who may qualify
- Ages
- 10 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age 10 months - 14 years _unilateral or bilateral acute septic hip arthritis
Key exclusion criteria (2 listed)
- Children with pre-existing other pathology of the affected hip, whether he / she has surgery for management of this pathology or not.
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 |
|---|---|---|
| Arthroscopic management of acute pediatric septic hip infecionThree-portals tractionless hip arthroscopy will be used to treat acute pediatric septic hip infection | Procedure or surgery | Intervention Group |
| Open debridement of acute pediatric septic hipsurgical drainage and debridement of acute septic hip in children via classic lateral approach | Procedure or surgery | Control Group |
Primary outcome
Modified Mckay's criteria
Time frame: One Year Follow-up
Excellent: painless, stable hip; no limp; more than 15 degrees of internal rotation. Good: painless, stable hip; slight limb or decreased motion , negative Trendelenburg sign Fair: minimum pain; moderate stiffness, positive Trendelenburg sign Poor: significant pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 6630490Fabry G, Meire E. Septic arthritis of the hip in children: poor results after late and inadequate treatment. J Pediatr Orthop. 1983 Sep;3(4):461-6. doi: 10.1097/01241398-198309000-00008.
- Background: PubMed 10795061Sucato DJ, Schwend RM, Gillespie R. Septic Arthritis of the Hip in Children. J Am Acad Orthop Surg. 1997 Oct;5(5):249-260. doi: 10.5435/00124635-199709000-00003.
- Background: PubMed 15292409Kocher MS, Mandiga R, Zurakowski D, Barnewolt C, Kasser JR. Validation of a clinical prediction rule for the differentiation between septic arthritis and transient synovitis of the hip in children. J Bone Joint Surg Am. 2004 Aug;86(8):1629-35. doi: 10.2106/00004623-200408000-00005.
- Background: PubMed 2199119Shaw BA, Kasser JR. Acute septic arthritis in infancy and childhood. Clin Orthop Relat Res. 1990 Aug;(257):212-25.
- Background: PubMed 12579000DeAngelis NA, Busconi BD. Hip arthroscopy in the pediatric population. Clin Orthop Relat Res. 2003 Jan;(406):60-3. doi: 10.1097/01.blo.0000043044.84315.90.
- Background: PubMed 33738199Ellis HB, Copley L, Pennock A, Nepple JJ, Willimon C, Mayer SW, Yen YM. Tractionless Hip Arthroscopy for Septic Arthritis in Children. Arthrosc Tech. 2021 Feb 19;10(3):e659-e667. doi: 10.1016/j.eats.2020.10.079. eCollection 2021 Mar.
- Background: PubMed 19308583El-Sayed AM. Treatment of early septic arthritis of the hip in children: comparison of results of open arthrotomy versus arthroscopic drainage. J Child Orthop. 2008 Jun;2(3):229-37. doi: 10.1007/s11832-008-0094-0. Epub 2008 Mar 6.
- Background: PubMed 1499198Bennett OM, Namnyak SS. Acute septic arthritis of the hip joint in infancy and childhood. Clin Orthop Relat Res. 1992 Aug;(281):123-32.
- Background: PubMed 33566696Donders CM, Spaans AJ, Bessems JHJM, van Bergen CJA. A systematic review of the optimal drainage technique for septic hip arthritis in children. Hip Int. 2022 Sep;32(5):685-693. doi: 10.1177/1120700021989666. Epub 2021 Feb 10.
- Background: PubMed 4817221McKay DW. A comparison of the innominate and the pericapsular osteotomy in the treatment of congenital dislocation of the hip. Clin Orthop Relat Res. 1974 Jan-Feb;(98):124-32. doi: 10.1097/00003086-197401000-00013. No abstract available.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic management of acute pediatric septic hip infecion and Open debridement of acute pediatric septic hip in people with Acute Pediatric Septic Hip Infection, run by Hesham Mohamed Elbaseet.
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 2 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: opening soon, as of the sponsor's last update on 31 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Mohammed, Phd (00201009876426, abdullahkamal500@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Mckay's criteria (time frame: One Year Follow-up). 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 NCT06505720, which also lists 10 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 31 Jul 2024.