Hinged Versus Conventional 8 Plate for Correction of Genu Valgum or Varum

NCT03378206 | Unknown DMC

• 1 other identifier: XH-17-013
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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. The hypothesis is that the hinged 8 plate provides low complications that this treatment is as good as the traditional one.

Conditions

Genu Valgum or Varum; Growth; Arrested, Bone; Epiphyseal Arrest, Lower Leg

Keywords

genu valgum or varum; eight-plate; epiphysis arrest; hemiepiphysiodesis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (4)

• The corrective rates of medial slope angle.

  2 years

• The corrective of Mechanical lateral distal femoral angle.

  2 years

• The movement of two arms of the hinged plate.

  2 years

• The residual stress on the implants.

  2 years

Study Arms (2)

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.

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.

Device: conventional 8-figure plate

Interventions

hinged 8-figure plate DEVICE

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.

Hinged 8-figure plate

conventional 8-figure plate DEVICE

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).

conventional 8-figure plate

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Related Publications (18)

• 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.

  PMID: 18153890 RESULT

• Sharma 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.

  PMID: 11448282 RESULT

• Bylski-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.

  PMID: 11675562 RESULT

• Gottliebsen 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.

  PMID: 23192490 RESULT

• Gros 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.

  PMID: 23617869 RESULT

• Zuege RC, Kempken TG, Blount WP. Epiphyseal stapling for angular deformity at the knee. J Bone Joint Surg Am. 1979 Apr;61(3):320-9.

  PMID: 429399 RESULT

• Burghardt 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.

  PMID: 23904903 RESULT

• Stevens 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.

  PMID: 17414005 RESULT

• Burghardt 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.

  PMID: 19308576 RESULT

• Boero 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.

  PMID: 22654982 RESULT

• Guzman 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.

  PMID: 21415941 RESULT

• Driscoll 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.

  PMID: 24172668 RESULT

• Aslani 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.

  PMID: 24172669 RESULT

• Lin 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.

  PMID: 23211739 RESULT

• Lee 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.

  PMID: 22568964 RESULT

• Schroerlucke S, Bertrand S, Clapp J, Bundy J, Gregg FO. Failure of Orthofix eight-Plate for the treatment of Blount disease. J Pediatr Orthop. 2009 Jan-Feb;29(1):57-60. doi: 10.1097/BPO.0b013e3181919b54.

  PMID: 19098648 RESULT

• Burghardt RD, Specht SC, Herzenberg JE. Mechanical failures of eight-plateguided growth system for temporary hemiepiphysiodesis. J Pediatr Orthop. 2010 Sep;30(6):594-7. doi: 10.1097/BPO.0b013e3181e4f591.

  PMID: 20733426 RESULT

• Wu Z, Zhao D, Zhao L, Liu J, Li H, Zhu J, Ma F, Porter DE. A comparison between a hinged plate and screw system and a conventional tension-band plate and screw system used for correction of an angular deformity of the lower limb: an animal study. J Orthop Surg Res. 2015 May 3;10:57. doi: 10.1186/s13018-015-0198-4.

  PMID: 25935152 RESULT

MeSH Terms

Conditions

Genu Valgum; Heart Arrest

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ziming Zhang, PhD

  Department of Pediatric Orthopedics, Xinhua Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziming Zhang, PhD

CONTACT

+86 13651756906; zmzhang23@163.com

Zhiqiang Zhang, MD

CONTACT

+86 18721772513

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Department of Pediatric Orthopedics

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: December 19, 2017
• Study Start: May 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: August 31, 2020
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share