Knee DeformityNCT03689959
Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis
A study testing Eight plate hemiepiphysiodesis in people with Knee Deformity, run by Assiut University at 1 site in Egypt.
Trial summary
The study aims to assess the effectiveness of hemiephysiodesis using eight plates in correction of fixed knee flexion deformities in children. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Knee Deformity
- What is being tested?
- Eight plate hemiepiphysiodesis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 1 Mar 2023
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fixed knee flexion deformity more than 10°
- Unilateral or bilateral cases
- 12 months or more predicted growth remaining
- No response to non-operative treatment (physical therapy, bracing, casting);
- Recurrent cases
Who cannot join
- Dynamic deformities due to spasticity
- Deformities responding to conservative treatment
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to assess the effectiveness of hemiephysiodesis using eight plates in correction of fixed knee flexion deformities in children.
Read the detailed description
Flexion contractures of the knee are quite disabling. They produce deleterious effects on knee biomechanics, quadriceps function, energy expenditure during gait and the overall ability to ambulate. These deformities occur secondary to a number of different etiologies including; congenital, traumatic, inflammatory and neuromuscular disorders with cerebral palsy (CP) being on the top of the list.
The main aim of correction of sagittal plane deformities of the knee is to restore the range of motion. Surgical options available for correction of knee flexion contractures include soft tissue modification, acute correction by osteotomies, gradual correction by external fixators and growth modulation by hemiephysiodesis.Extensive soft tissue surgery may be needed for correction of knee deformities with potential risk of neurovascular damage and wound complications. Supracondylar extension osteotomies have been widely used, however prolonged immobilization and associated neurovascular insults have always been major concerns. External fixators are cumbersome and may produce muscle tethering and pin tract infections.
There are few studies in the literature reporting the use of anterior hemiepiphysiodesis for correction of knee flexion contracture.
Our study question can be summarized as follows; Is hemiepiphysiodesis by eight plates effective for correction of fixed knee flexion deformities in children ?
- Conditions
- Knee Deformity
- Being tested
- Eight plate hemiepiphysiodesis
- Keywords
- knee, flexion deformity, hemiepiphysiodesis, eight plate, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eight plate hemiepiphysiodesisProcedure or surgery
Also called Guided growth
Patient is positioned in a classic supine position. Under fluoroscopic guidance and tourniquet hemostasis, the distal femoral physis is identified. Two 3-cm incisions are made, one on either side of the patella, centred at the level of the physis. The capsule and synovium are opened to visualize the sulcus and place the plates just outside the articular portion of the joint surface, medially and laterally. Care is taken not to damage the periosteum and a needle is inserted into the physis. The 8-plate, which has a central hole, is slipped over the needle and screws inserted. After wound closure, a soft dressing is used, and the patient is allowed to ambulate as tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | 13 child with fixed knee flexion deformity more than 10° on one or both sides with 12 months or more predicted growth remaining subjected to eight plate hemiepiphysiodesis of the distal femur Receives: Procedure: Eight plate hemiepiphysiodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of flexion deformity
The angle between the anterior borders of thigh and leg measured clinically with a goniometer
Measured: One year
Secondary outcomes (2)
Complications
Wound complications, metal failure
Measured: One year
Rate of correction
Time needed for correction of deformity
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee DeformityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Yahya Abdel Azeem Hassanein, Assiut University
- Investigators
- Mohamed Y. Hassanein, M.Sc., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689959
- Sponsor's protocol ID
- UMIN000018950
- Status last verified
- Jul 2023
- First submitted
- 27 Sep 2018
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Spiro 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 22307752Klatt J, Stevens PM. Guided growth for fixed knee flexion deformity. J Pediatr Orthop. 2008 Sep;28(6):626-31. doi: 10.1097/BPO.0b013e318183d573.
PubMed 18724198Spiro AS, Babin K, Lipovac S, Rupprecht M, Meenen NM, Rueger JM, Stuecker R. Anterior femoral epiphysiodesis for the treatment of fixed knee flexion deformity in spina bifida patients. J Pediatr Orthop. 2010 Dec;30(8):858-62. doi: 10.1097/BPO.0b013e3181f10297.
PubMed 21102213Heydarian K, Akbarnia BA, Jabalameli M, Tabador K. Posterior capsulotomy for the treatment of severe flexion contractures of the knee. J Pediatr Orthop. 1984 Nov;4(6):700-4. doi: 10.1097/01241398-198411000-00009.
PubMed 6511897Inan M, Sarikaya IA, Yildirim E, Guven MF. Neurological complications after supracondylar femoral osteotomy in cerebral palsy. J Pediatr Orthop. 2015 Apr-May;35(3):290-5. doi: 10.1097/BPO.0000000000000264.
PubMed 25075896Carbonell PG, Valero JV, Fernandez PD, Vicente-Franqueira JR. Monolateral external fixation for the progressive correction of neurological spastic knee flexion contracture in children. Strategies Trauma Limb Reconstr. 2007 Dec;2(2-3):91-7. doi: 10.1007/s11751-007-0026-4. Epub 2007 Dec 4.
PubMed 18427750
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis
- ClinicalTrials.gov ID
- NCT03689959
- Acronym / sponsor ID
- UMIN000018950
- Conditions
- Knee Deformity
- Keywords
- knee, flexion deformity, hemiepiphysiodesis, eight plate, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 1 Oct 2018 (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 study aims to assess the effectiveness of hemiephysiodesis using eight plates in correction of fixed knee flexion deformities in children.
Detailed description
Flexion contractures of the knee are quite disabling. They produce deleterious effects on knee biomechanics, quadriceps function, energy expenditure during gait and the overall ability to ambulate. These deformities occur secondary to a number of different etiologies including; congenital, traumatic, inflammatory and neuromuscular disorders with cerebral palsy (CP) being on the top of the list.
The main aim of correction of sagittal plane deformities of the knee is to restore the range of motion. Surgical options available for correction of knee flexion contractures include soft tissue modification, acute correction by osteotomies, gradual correction by external fixators and growth modulation by hemiephysiodesis.Extensive soft tissue surgery may be needed for correction of knee deformities with potential risk of neurovascular damage and wound complications. Supracondylar extension osteotomies have been widely used, however prolonged immobilization and associated neurovascular insults have always been major concerns. External fixators are cumbersome and may produce muscle tethering and pin tract infections.
There are few studies in the literature reporting the use of anterior hemiepiphysiodesis for correction of knee flexion contracture.
Our study question can be summarized as follows; Is hemiepiphysiodesis by eight plates effective for correction of fixed knee flexion deformities in children ?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Eight plate hemiepiphysiodesis13 child with fixed knee flexion deformity more than 10° on one or both sides with 12 months or more predicted growth remaining subjected to eight plate hemiepiphysiodesis of the distal femur |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Fixed knee flexion deformity more than 10°
- Unilateral or bilateral cases
- 12 months or more predicted growth remaining
- No response to non-operative treatment (physical therapy, bracing, casting);
- Recurrent cases
Key exclusion criteria (2 listed)
- Dynamic deformities due to spasticity
- Deformities responding to conservative treatment
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 |
|---|---|---|
| Eight plate hemiepiphysiodesisAlso: Guided growthPatient is positioned in a classic supine position. Under fluoroscopic guidance and tourniquet hemostasis, the distal femoral physis is identified. Two 3-cm incisions are made, one on either side of the patella, centred at the level of the physis. The capsule and synovium are opened to visualize the sulcus and place the plates just outside the articular portion of the joint surface, medially and laterally. Care is taken not to damage the periosteum and a needle is inserted into the physis. The 8-plate, which has a central hole, is slipped over the needle and screws inserted. After wound closure, a soft dressing is used, and the patient is allowed to ambulate as tolerated. | Procedure or surgery | Patients |
Primary outcome
Degree of flexion deformity
Time frame: One year
The angle between the anterior borders of thigh and leg measured clinically with a goniometer
2 secondary outcomes
Complications
Time frame: One year
Rate of correction
Time frame: One 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 19 Jul 2023.
- 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.
- Results publication: PubMed 18724198Klatt J, Stevens PM. Guided growth for fixed knee flexion deformity. J Pediatr Orthop. 2008 Sep;28(6):626-31. doi: 10.1097/BPO.0b013e318183d573.
- Results publication: PubMed 21102213Spiro AS, Babin K, Lipovac S, Rupprecht M, Meenen NM, Rueger JM, Stuecker R. Anterior femoral epiphysiodesis for the treatment of fixed knee flexion deformity in spina bifida patients. J Pediatr Orthop. 2010 Dec;30(8):858-62. doi: 10.1097/BPO.0b013e3181f10297.
- Results publication: PubMed 6511897Heydarian K, Akbarnia BA, Jabalameli M, Tabador K. Posterior capsulotomy for the treatment of severe flexion contractures of the knee. J Pediatr Orthop. 1984 Nov;4(6):700-4. doi: 10.1097/01241398-198411000-00009.
- Results publication: PubMed 25075896Inan M, Sarikaya IA, Yildirim E, Guven MF. Neurological complications after supracondylar femoral osteotomy in cerebral palsy. J Pediatr Orthop. 2015 Apr-May;35(3):290-5. doi: 10.1097/BPO.0000000000000264.
- Results publication: PubMed 18427750Carbonell PG, Valero JV, Fernandez PD, Vicente-Franqueira JR. Monolateral external fixation for the progressive correction of neurological spastic knee flexion contracture in children. Strategies Trauma Limb Reconstr. 2007 Dec;2(2-3):91-7. doi: 10.1007/s11751-007-0026-4. Epub 2007 Dec 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 Y. Hassanein, M.Sc. principal investigator
Assiut 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 Eight plate hemiepiphysiodesis in people with Knee Deformity, run by Assiut 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 5 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: finished, as of the sponsor's last update on 19 Jul 2023. 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 flexion deformity (time frame: One year). 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 NCT03689959, which also lists 6 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 19 Jul 2023.