Genu Valgum or VarumNCT03378206
Hinged Versus Conventional 8 Plate for Correction of Genu Valgum or Varum
A study testing hinged 8-figure plate and conventional 8-figure plate in people with Genu Valgum or Varum and Growth; Arrested, Bone, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
To assess the therapeutic effect of hinged 8-figure plate by comparing with the traditional 8-figure plate through a randomized controlled clinical trial by assessing the differences between preoperative and postoperative data. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Genu Valgum or Varum, Growth; Arrested, Bone, Epiphyseal Arrest, Lower Leg
- What is being tested?
- hinged 8-figure plate and conventional 8-figure plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 31 Aug 2020
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Idiopathic genu valgus or varum
- Without any treatment
- lower limb mechanical axis over the tibial plateau in the range of 1/2;
- Epiphyseal not yet closed, with more than 12 months of growth potential
Who cannot join
- Physiological genu valgus or varum
- Epiphyseal have closed or no growth potential
- Pathological limb deformity(Blount disease, inflammation,trauma)
- Other causes of lower limb angular deformity.
- With surgical contraindications
Trial locations and contacts
No sites are listed yet.
Zhiqiang Zhang, MD contact
About this study
Official title: Comparison of the Outcomes of the Treatment of Semiepiphysiodesis Using Hinged and Conventional 8-figure Plates: A Randomized Controlled Clinical Trial
To assess the therapeutic effect of hinged 8-figure plate by comparing with the traditional 8-figure plate through a randomized controlled clinical trial by assessing the differences between preoperative and postoperative data.
The hypothesis is that the hinged 8 plate provides low complications that this treatment is as good as the traditional one.
Read the detailed description
Angular deformities of the lower limb is major clinical problems encountered in pediatric orthopedics. Deformities can be either valgus or varus and most commonly affect the knee joint, which may result in patella dislocation, gait instability and serious impact on the appearance and function of the lower limbs. Biomechanical studies and gait analysis found that genu varus increased medial articular surface pressure of the knee, while genu valgus increased lateral articular surface pressure, and both of them are the risk factors for osteoarthritis. Surgical treatment techniques include osteotomy and hemiepipysidesis. Osteotomy surgery is the gold standard for severe angular deformity or epiphyseal closed patients, but it was associated with lots of complications, including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection, nonunion and requiring a long recovery time. While, for patients whose epiphyseal is not closed, the traditional 8 plate hemiepipysidesis has fewer complications. However, it showed some problems in clinical applications, such as steel plate or screw broken. The investigators designed a new hinged 8 plate, which has two arms and a built-in hinge. Based on the previous studies, investigators designed the rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking. The plate had been tested on animal models that the use of the hinged plate and screw system may be a more reliable technique with minimal complications for correction of angular deformities of the lower limb.
- Being tested
- hinged 8-figure plate, conventional 8-figure plate
- Keywords
- genu valgum or varum, eight-plate, epiphysis arrest, hemiepiphysiodesis
- Medical subject headings
- Genu Valgum, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hinged 8-figure plateDevice
Hinged 8-figure plate has two arms and a built-in hinge. The rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking.
conventional 8-figure plateDevice
Conventional 8-figure plate is a widespread device to treat angular deformity of lower limbs with moderate successful rate. The device was designed based on the principle of tension band model. It consists of a plate and two screws (epiphyseal screw and metaphyseal screw).
| Study group | Role | What they receive |
|---|---|---|
| Hinged 8-figure plate | Experimental | Hinged 8-figure plate is a novel devise that has modifications in order to improve the treatment effect of conventional 8-figure plate. This arm will be used to verify the effectiveness and feasibility of the modification. Receives: Device: hinged 8-figure plate |
| conventional 8-figure plate | Active comparator | Conventional 8-figure plate is widespread method to treat genu varum and valgus. This arm, as a comparator, will be the control group to verify the feasibility of the novel hinged 8-figure plate. Receives: Device: conventional 8-figure plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complications.
Surgery related complications including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection and so on will be observed until correction of deformity.
Measured: 2 years
Secondary outcomes (4)
The corrective rates of medial slope angle.
The angle of medial slope will be measured when reexamination until the correction of deformity, which was used to calculate the corrective rates.
Measured: 2 years
The corrective of Mechanical lateral distal femoral angle.
The corrective of Mechanical lateral distal femoral angle will be measured when reexamination until the correction of deformity. And investigators will calculating the change of this angle.
Measured: 2 years
The movement of two arms of the hinged plate.
The movement of two arms during the experiment will be noted by the changing of two arms angle when reexamination until the correction of deformity.
Measured: 2 years
The residual stress on the implants.
Residual stress (remaining stress of the sample after implant removal) at the rim of the metaphyseal screw hole will be measured using X-ray diffraction.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 May 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Genu Valgum or VarumStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziming Zhang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Ziming Zhang, PhD, Principal investigator, Department of Pediatric Orthopedics, Xinhua Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378206
- Sponsor's protocol ID
- XH-17-013
- Status last verified
- Apr 2018
- First submitted
- 25 Sep 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
BLOUNT WP, CLARKE GR. Control of bone growth by epiphyseal stapling; a preliminary report. J Bone Joint Surg Am. 1949 Jul;31A(3):464-78. No abstract available.
PubMed 18153890Sharma L, Song J, Felson DT, Cahue S, Shamiyeh E, Dunlop DD. The role of knee alignment in disease progression and functional decline in knee osteoarthritis. JAMA. 2001 Jul 11;286(2):188-95. doi: 10.1001/jama.286.2.188.
PubMed 11448282Bylski-Austrow DI, Wall EJ, Rupert MP, Roy DR, Crawford AH. Growth plate forces in the adolescent human knee: a radiographic and mechanical study of epiphyseal staples. J Pediatr Orthop. 2001 Nov-Dec;21(6):817-23.
PubMed 11675562Gottliebsen M, Rahbek O, Poulsen HD, Moller-Madsen B. Similar growth plate morphology in stapling and tension band plating hemiepiphysiodesis: a porcine experimental histomorphometric study. J Orthop Res. 2013 Apr;31(4):574-9. doi: 10.1002/jor.22276. Epub 2012 Nov 28.
PubMed 23192490Gros DF, Milanak ME, Brady KT, Back SE. Frequency and severity of comorbid mood and anxiety disorders in prescription opioid dependence. Am J Addict. 2013 May-Jun;22(3):261-5. doi: 10.1111/j.1521-0391.2012.12008.x.
PubMed 23617869Zuege RC, Kempken TG, Blount WP. Epiphyseal stapling for angular deformity at the knee. J Bone Joint Surg Am. 1979 Apr;61(3):320-9.
PubMed 429399Burghardt RD, Kanellopoulos AD, Herzenberg JE. A technical note on improved instrumentation for Blount staple insertion. J Child Orthop. 2012 Aug;6(4):347-50. doi: 10.1007/s11832-012-0422-2. Epub 2012 Aug 9.
PubMed 23904903Stevens PM. Guided growth for angular correction: a preliminary series using a tension band plate. J Pediatr Orthop. 2007 Apr-May;27(3):253-9. doi: 10.1097/BPO.0b013e31803433a1.
PubMed 17414005Burghardt RD, Herzenberg JE, Standard SC, Paley D. Temporary hemiepiphyseal arrest using a screw and plate device to treat knee and ankle deformities in children: a preliminary report. J Child Orthop. 2008 Jun;2(3):187-97. doi: 10.1007/s11832-008-0096-y. Epub 2008 Mar 26.
PubMed 19308576Boero S, Michelis MB, Riganti S. Use of the eight-Plate for angular correction of knee deformities due to idiopathic and pathologic physis: initiating treatment according to etiology. J Child Orthop. 2011 Jun;5(3):209-16. doi: 10.1007/s11832-011-0344-4. Epub 2011 May 12.
PubMed 22654982Guzman H, Yaszay B, Scott VP, Bastrom TP, Mubarak SJ. Early experience with medial femoral tension band plating in idiopathic genu valgum. J Child Orthop. 2011 Feb;5(1):11-7. doi: 10.1007/s11832-010-0310-6. Epub 2010 Dec 8.
PubMed 21415941Driscoll MD, Linton J, Sullivan E, Scott A. Medial malleolar screw versus tension-band plate hemiepiphysiodesis for ankle valgus in the skeletally immature. J Pediatr Orthop. 2014 Jun;34(4):441-6. doi: 10.1097/BPO.0000000000000116.
PubMed 24172668Aslani H, Panjavy B, Bashy RH, Tabrizi A, Nazari B. The efficacy and complications of 2-hole 3.5 mm reconstruction plates and 4 mm noncanulated cancellous screws for temporary hemiepiphysiodesis around the knee. J Pediatr Orthop. 2014 Jun;34(4):462-6. doi: 10.1097/BPO.0000000000000115.
PubMed 24172669Lin TY, Kao HK, Li WC, Yang WE, Chang CH. Guided growth by a stainless-steel tubular plate. J Pediatr Orthop B. 2013 Jul;22(4):306-10. doi: 10.1097/BPB.0b013e32835bc42d.
PubMed 23211739Lee HJ, Oh CW, Song KS, Kyung HS, Min WK, Park BC. Guided growth with a noncannulated screw-plate system for angular deformity of the knee: a preliminary report. J Pediatr Orthop B. 2012 Jul;21(4):339-47. doi: 10.1097/BPB.0b013e3283547198.
PubMed 22568964
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Outcomes of the Treatment of Semiepiphysiodesis Using Hinged and Conventional 8-figure Plates: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03378206
- Acronym / sponsor ID
- XH-17-013
- Keywords
- genu valgum or varum, eight-plate, epiphysis arrest, hemiepiphysiodesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 19 Dec 2017 (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.
To assess the therapeutic effect of hinged 8-figure plate by comparing with the traditional 8-figure plate through a randomized controlled clinical trial by assessing the differences between preoperative and postoperative data.
The hypothesis is that the hinged 8 plate provides low complications that this treatment is as good as the traditional one.
Detailed description
Angular deformities of the lower limb is major clinical problems encountered in pediatric orthopedics. Deformities can be either valgus or varus and most commonly affect the knee joint, which may result in patella dislocation, gait instability and serious impact on the appearance and function of the lower limbs. Biomechanical studies and gait analysis found that genu varus increased medial articular surface pressure of the knee, while genu valgus increased lateral articular surface pressure, and both of them are the risk factors for osteoarthritis. Surgical treatment techniques include osteotomy and hemiepipysidesis. Osteotomy surgery is the gold standard for severe angular deformity or epiphyseal closed patients, but it was associated with lots of complications, including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection, nonunion and requiring a long recovery time. While, for patients whose epiphyseal is not closed, the traditional 8 plate hemiepipysidesis has fewer complications. However, it showed some problems in clinical applications, such as steel plate or screw broken. The investigators designed a new hinged 8 plate, which has two arms and a built-in hinge. Based on the previous studies, investigators designed the rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking. The plate had been tested on animal models that the use of the hinged plate and screw system may be a more reliable technique with minimal complications for correction of angular deformities of the lower limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hinged 8-figure plate | Experimental | Device: hinged 8-figure plateHinged 8-figure plate is a novel devise that has modifications in order to improve the treatment effect of conventional 8-figure plate. This arm will be used to verify the effectiveness and feasibility of the modification. |
| conventional 8-figure plate | Active comparator | Device: conventional 8-figure plateConventional 8-figure plate is widespread method to treat genu varum and valgus. This arm, as a comparator, will be the control group to verify the feasibility of the novel hinged 8-figure plate. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Idiopathic genu valgus or varum
- Without any treatment
- lower limb mechanical axis over the tibial plateau in the range of 1/2;
- Epiphyseal not yet closed, with more than 12 months of growth potential
Key exclusion criteria (5 listed)
- Physiological genu valgus or varum
- Epiphyseal have closed or no growth potential
- Pathological limb deformity(Blount disease, inflammation,trauma)
- Other causes of lower limb angular deformity.
- With surgical contraindications
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 |
|---|---|---|
| hinged 8-figure plateHinged 8-figure plate has two arms and a built-in hinge. The rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking. | Device | Hinged 8-figure plate |
| conventional 8-figure plateConventional 8-figure plate is a widespread device to treat angular deformity of lower limbs with moderate successful rate. The device was designed based on the principle of tension band model. It consists of a plate and two screws (epiphyseal screw and metaphyseal screw). | Device | conventional 8-figure plate |
Primary outcome
The complications.
Time frame: 2 years
Surgery related complications including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection and so on will be observed until correction of deformity.
4 secondary outcomes
The corrective rates of medial slope angle.
Time frame: 2 years
The corrective of Mechanical lateral distal femoral angle.
Time frame: 2 years
The movement of two arms of the hinged plate.
Time frame: 2 years
The residual stress on the implants.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Results publication: PubMed 18153890BLOUNT WP, CLARKE GR. Control of bone growth by epiphyseal stapling; a preliminary report. J Bone Joint Surg Am. 1949 Jul;31A(3):464-78. No abstract available.
- Results publication: PubMed 11448282Sharma L, Song J, Felson DT, Cahue S, Shamiyeh E, Dunlop DD. The role of knee alignment in disease progression and functional decline in knee osteoarthritis. JAMA. 2001 Jul 11;286(2):188-95. doi: 10.1001/jama.286.2.188.
- Results publication: PubMed 11675562Bylski-Austrow DI, Wall EJ, Rupert MP, Roy DR, Crawford AH. Growth plate forces in the adolescent human knee: a radiographic and mechanical study of epiphyseal staples. J Pediatr Orthop. 2001 Nov-Dec;21(6):817-23.
- Results publication: PubMed 23192490Gottliebsen M, Rahbek O, Poulsen HD, Moller-Madsen B. Similar growth plate morphology in stapling and tension band plating hemiepiphysiodesis: a porcine experimental histomorphometric study. J Orthop Res. 2013 Apr;31(4):574-9. doi: 10.1002/jor.22276. Epub 2012 Nov 28.
- Results publication: PubMed 23617869Gros DF, Milanak ME, Brady KT, Back SE. Frequency and severity of comorbid mood and anxiety disorders in prescription opioid dependence. Am J Addict. 2013 May-Jun;22(3):261-5. doi: 10.1111/j.1521-0391.2012.12008.x.
- Results publication: PubMed 429399Zuege RC, Kempken TG, Blount WP. Epiphyseal stapling for angular deformity at the knee. J Bone Joint Surg Am. 1979 Apr;61(3):320-9.
- Results publication: PubMed 23904903Burghardt RD, Kanellopoulos AD, Herzenberg JE. A technical note on improved instrumentation for Blount staple insertion. J Child Orthop. 2012 Aug;6(4):347-50. doi: 10.1007/s11832-012-0422-2. Epub 2012 Aug 9.
- Results publication: PubMed 17414005Stevens PM. Guided growth for angular correction: a preliminary series using a tension band plate. J Pediatr Orthop. 2007 Apr-May;27(3):253-9. doi: 10.1097/BPO.0b013e31803433a1.
- Results publication: PubMed 19308576Burghardt RD, Herzenberg JE, Standard SC, Paley D. Temporary hemiepiphyseal arrest using a screw and plate device to treat knee and ankle deformities in children: a preliminary report. J Child Orthop. 2008 Jun;2(3):187-97. doi: 10.1007/s11832-008-0096-y. Epub 2008 Mar 26.
- Results publication: PubMed 22654982Boero S, Michelis MB, Riganti S. Use of the eight-Plate for angular correction of knee deformities due to idiopathic and pathologic physis: initiating treatment according to etiology. J Child Orthop. 2011 Jun;5(3):209-16. doi: 10.1007/s11832-011-0344-4. Epub 2011 May 12.
- Results publication: PubMed 21415941Guzman H, Yaszay B, Scott VP, Bastrom TP, Mubarak SJ. Early experience with medial femoral tension band plating in idiopathic genu valgum. J Child Orthop. 2011 Feb;5(1):11-7. doi: 10.1007/s11832-010-0310-6. Epub 2010 Dec 8.
- Results publication: PubMed 24172668Driscoll MD, Linton J, Sullivan E, Scott A. Medial malleolar screw versus tension-band plate hemiepiphysiodesis for ankle valgus in the skeletally immature. J Pediatr Orthop. 2014 Jun;34(4):441-6. doi: 10.1097/BPO.0000000000000116.
- Individual participant dataSharing planned: No
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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.
Zhiqiang Zhang, MD contact
Ziming Zhang, PhD principal investigator
Department of Pediatric Orthopedics, Xinhua Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing hinged 8-figure plate and conventional 8-figure plate in people with Genu Valgum or Varum and Growth; Arrested, Bone, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 4 inclusion and 5 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 10 Apr 2018. 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 Ziming Zhang, PhD (+86 13651756906, zmzhang23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complications. (time frame: 2 years). 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 NCT03378206, which also lists 18 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 10 Apr 2018.