Hinged Versus Conventional 8 Plate for Correction of Genu Valgum or Varum
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03378206|
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : April 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Genu Valgum or Varum Growth; Arrested, Bone Epiphyseal Arrest, Lower Leg||Device: hinged 8-figure plate Device: conventional 8-figure plate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Outcomes of the Treatment of Semiepiphysiodesis Using Hinged and Conventional 8-figure Plates: A Randomized Controlled Clinical Trial|
|Estimated Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||August 31, 2020|
Experimental: Hinged 8-figure plate
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
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.
Active Comparator: conventional 8-figure plate
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
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).
- 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.
- The corrective rates of medial slope angle. [ Time Frame: 2 years ]The angle of medial slope will be measured when reexamination until the correction of deformity, which was used to calculate the corrective rates.
- The corrective of Mechanical lateral distal femoral angle. [ Time Frame: 2 years ]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.
- The movement of two arms of the hinged plate. [ Time Frame: 2 years ]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.
- The residual stress on the implants. [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378206
|Contact: Ziming Zhang, PhD||+86 email@example.com|
|Contact: Zhiqiang Zhang, MD||+86 18721772513|
|Principal Investigator:||Ziming Zhang, PhD||Department of Pediatric Orthopedics, Xinhua Hospital affiliated to Shanghai Jiao Tong University, School of Medicine|