Flexion Deformity of KneeNCT04911686
Correction of Fixed Knee Flexion Deformity in Children Distraction by Cast Wedge and Rod Lengthening
An observational study of Flexion Deformity of Knee, run by Assiut University.
Trial summary
The aim of our study is to produce gradual correction of FKFD in younger children. Read more about this study
- Who is it for?
- Ages Up to 4 years
- Conditions the study is for
- Flexion Deformity of Knee
- What is being tested?
- rod distraction
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Mar 2024
- 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 Up to 4 years
- All sexes
- Child
Study population: Children with FKFD Age < 4 years.
Who may be able to join
- Children with FKFD.
- Age < 4 years.
- FKFD due to congenital, traumatic, neuromuscular, infections, metabolic disorders and skeletal dysplasias.
Who cannot join
- 1. Older children less than 4 years 2. Recent Post-burn contractures and cases with unsuitable skin conditions.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of our study is to produce gradual correction of FKFD in younger children.
Read the detailed description
Management of pediatric fixed knee flexion deformities (FKFD) has always been a challenge for orthopedic surgeons. They occur due to a variety of causes, including cerebral palsy, arthrogryposis, spina bifida, trauma, and many others. The deleterious effects of FKFD include instability of gait and balance, exhaustion of extensor mechanism, and anterior knee pain, which together produce marked limitation of the activities of daily living in affected children .
Many options have been proposed for the correction of FKFD, with each having its pros and cons. Hamstring release and posterior capsulotomy are frequently used. However, extensive soft tissue release may be needed to treat severe deformities with the risk of neurovascular compromise and genu recurvatum. Supracondylar extension osteotomy with patellar tendon advancement requires postoperative non-weight bearing for at least three weeks and is associated with risk of neurovascular damage and coronal plane deformities and it is mostly used in older children and adolescent . Gradual distraction by ring fixators may be complicated by pin tract problems, fractures, and recurrence .
Our study entails the application of a simple method for correction of FKFD in younger children using a simple cast distraction technique. This conservative method aims at avoiding the complications of surgery in children while achieving a reasonable amount of correction.
- Conditions
- Flexion Deformity of Knee
- Being tested
- rod distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rod distractionDevice
Also called hemiephysiodesis
Our study entails the application of a simple method for correction of FKFD in younger children using a simple cast distraction technique. This conservative method aims at avoiding the complications of surgery in children while achieving a reasonable amount of correction.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of fixed knee flexion deformities in children using cast and rod distraction
Amount of correction of the flexion deformity measured in degrees
Measured: baseline
Secondary outcomes (1)
Correction of fixed knee flexion deformities in children using cast and rod distraction
Rate of correction Monitor patients and report on complication like severe knee joint pain or posterior translation of tibia within the study period, pressure ulcers caused by cast indentation.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 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 Flexion Deformity of KneeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alm-Eldeen khalf sholkamy, Assiut University
- Investigators
- Mohamed Khaled Hassan Ahmed, professor, Study director, Analysis and interpretation of data
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911686
- Sponsor's protocol ID
- Knee flexion deformities
- Status last verified
- Mar 2021
- First submitted
- 28 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balci HI, Kocaoglu M, Eralp L, Bilen FE. Knee flexion contracture in haemophilia: treatment with circular external fixator. Haemophilia. 2014 Nov;20(6):879-83. doi: 10.1111/hae.12478. Epub 2014 Aug 21.
PubMed 25143070Spiro AS, Stenger P, Hoffmann M, Vettorazzi E, Babin K, Lipovac S, Kolb JP, Novo de Oliveira A, Rueger JM, Stuecker R. Treatment of fixed knee flexion deformity by anterior distal femoral stapling. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2413-8. doi: 10.1007/s00167-012-1915-8. Epub 2012 Feb 4.
PubMed 22307752
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Fixed Knee Flexion Deformity in Children Distraction by Cast Wedge and Rod Lengthening
- ClinicalTrials.gov ID
- NCT04911686
- Acronym / sponsor ID
- Knee flexion deformities
- Conditions
- Flexion Deformity of Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 3 Jun 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 aim of our study is to produce gradual correction of FKFD in younger children.
Detailed description
Management of pediatric fixed knee flexion deformities (FKFD) has always been a challenge for orthopedic surgeons. They occur due to a variety of causes, including cerebral palsy, arthrogryposis, spina bifida, trauma, and many others. The deleterious effects of FKFD include instability of gait and balance, exhaustion of extensor mechanism, and anterior knee pain, which together produce marked limitation of the activities of daily living in affected children .
Many options have been proposed for the correction of FKFD, with each having its pros and cons. Hamstring release and posterior capsulotomy are frequently used. However, extensive soft tissue release may be needed to treat severe deformities with the risk of neurovascular compromise and genu recurvatum. Supracondylar extension osteotomy with patellar tendon advancement requires postoperative non-weight bearing for at least three weeks and is associated with risk of neurovascular damage and coronal plane deformities and it is mostly used in older children and adolescent . Gradual distraction by ring fixators may be complicated by pin tract problems, fractures, and recurrence .
Our study entails the application of a simple method for correction of FKFD in younger children using a simple cast distraction technique. This conservative method aims at avoiding the complications of surgery in children while achieving a reasonable amount of correction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with FKFD Age < 4 years.
Key inclusion criteria (3 listed)
- Children with FKFD.
- Age < 4 years.
- FKFD due to congenital, traumatic, neuromuscular, infections, metabolic disorders and skeletal dysplasias.
Key exclusion criteria (1 listed)
- 1. Older children less than 4 years 2. Recent Post-burn contractures and cases with unsuitable skin conditions.
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 |
|---|---|---|
| rod distractionAlso: hemiephysiodesisOur study entails the application of a simple method for correction of FKFD in younger children using a simple cast distraction technique. This conservative method aims at avoiding the complications of surgery in children while achieving a reasonable amount of correction. | Device | – |
Primary outcome
Correction of fixed knee flexion deformities in children using cast and rod distraction
Time frame: baseline
Amount of correction of the flexion deformity measured in degrees
1 secondary outcome
Correction of fixed knee flexion deformities in children using cast and rod distraction
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Background: PubMed 25143070Balci HI, Kocaoglu M, Eralp L, Bilen FE. Knee flexion contracture in haemophilia: treatment with circular external fixator. Haemophilia. 2014 Nov;20(6):879-83. doi: 10.1111/hae.12478. Epub 2014 Aug 21.
- Background: PubMed 22307752Spiro AS, Stenger P, Hoffmann M, Vettorazzi E, Babin K, Lipovac S, Kolb JP, Novo de Oliveira A, Rueger JM, Stuecker R. Treatment of fixed knee flexion deformity by anterior distal femoral stapling. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2413-8. doi: 10.1007/s00167-012-1915-8. Epub 2012 Feb 4.
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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.
Mohamed Khaled Hassan Ahmed, professor study director
Analysis and interpretation of data
Questions about this trial
What is this clinical trial studying?
An observational study of Flexion Deformity of Knee, 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 3 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 Jun 2021. 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 Alm Eldeen khalf sholkamy, master (01140876327, alam.khalalf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correction of fixed knee flexion deformities in children using cast and rod distraction (time frame: baseline). 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 NCT04911686, 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 2021.