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Clinical Trials/NCT03378206
NCT03378206UnknownNot Applicable

Comparison of the Outcomes of the Treatment of Semiepiphysiodesis Using Hinged and Conventional 8-figure Plates: A Randomized Controlled Clinical Trial

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine0 sites80 target enrollmentStarted: May 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
80
Primary Endpoint
The complications.

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: hinged 8-figure plate (Device)

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.

Intervention: conventional 8-figure plate (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ziming Zhang

Deputy director of Department of Pediatric Orthopedics

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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