Novel Pedicle Screws Used for Corrective Surgery in Spinal Deformity

NCT06144879 | Unknown

• 1 other identifier: qinxiaodong1991
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

There are still a large number of severe spinal deformity cases which would keep progressing without treatment. These patients not only have severe appearance deformity, but also suffer from cardiopulmonary compression, reduced abdominal volume, and even spinal cord injury. It is crucial to provide safe and effective surgical intervention for these patients. The corrective surgery with 3-column osteotomy is reported to be an effective surgical strategy for severe spinal deformity. However, due to the great corrective stress on the rods, there is an increased number of patients requiring revision surgery due to rod fracture (3.7%-15%). In patients with 3-column osteotomy, the osteotomy area and the upper and lower adjacent segments are mostly stress-concentrated areas, and the rod is prone to fatigue fracture. Therefore, it is necessary to reinforce the osteotomy area and adjacent segments to reduce the risk of rod fracture. Our previous study found the risk of rod fracture could be reduced by using satellite rods with duet connectors or dominos. However, in the traditional satellite rod technology, the connection of the main rod and the satellite rod rely on the traditional single slot screw and duet connectors. The two are separated and not a whole in the mechanical structure. The stability of the fixation is relatively insufficient, and stil deserves room for improvement. Based on the traditional duet connectors, we further invent a novel dual-headed pedicle screw, which is an combination of traditional single slot screw and duet connector. Compared with the traditional duet connector, the novel dual-headed pedicle screw theoretically has stronger stability between the main rod and satellite rod, due to its integration of screw and connector. Hence, the purpose of this study is to verify the strong stability of the novel dual-headed screw by biomechanical study in cadavers performed with long spinal fusion (T12-pelvis) with L3 pedicle subtraction osteotomy (PSO). And to further investigate its effectiveness in severe adult spinal deformity patients receiving corrective surgery with PSO. If the biomechanical properties and clinical effects of the novel dual-headed screw have been confirmed, the promotion of the product has great prospects in the world. The severe spinal deformity patients would benefit from this study when they receive spinal corrective surgery with 3-column osteotomy, using satellite rods technology by this novel dual-headed screw.

Conditions

Spine Deformity

Keywords

dual-headed pedicle screw

Outcome Measures

Primary Outcomes (18)

• Cobb angle of scoliosis (°)

  Radiographic parameters measured on X-ray by Surgimap: the angle of the major curve in coronal X-ray

  1 week after operation

• Cobb angle of kyphosis (°)

  Radiographic parameters measured on X-ray by Surgimap: the angle of the kyphosis in sagittal X-ray

  1 week after operation

• Coronal balance (mm)

  Radiographic parameters measured on X-ray by Surgimap: the distance between C7 plumb line (C7PL) and center sacral vertical line (CSVL) in coronal X-ray

  1 week after operation

• Sagittal balance (mm)

  Radiographic parameters measured on X-ray by Surgimap: the distance between C7PL and the posterior edge of sacrum in sagittal X-ray

  1 week after operation

• Rod broken rate (%)

  The ratio: number of patients with rod broken/ number of patients received surgery

  1 week after operation

• Screw broke rate(%)

  The ratio: number of patients with screw broken/ number of patients received surgery

  1 week after operation

• Coronal decompensation rate(%)

  The ratio: number of patients with coronal decompensation / number of patients received surgery

  1 week after operation

• Sagittal decompensation(%)

  The ratio: number of patients with sagittal decompensation / number of patients received surgery

  1 week after operation

• Short form-36 health survey（SF-36）

  SF-36 were calculated, including physical functioning, role physical, bodily pain, general health, vitality,social functioning, role-emotional and mental health.The SF-36 score is expressed as a number between 0 and 100. The higher the number, the better the health outcome.

  1 week after operation

• Cobb angle of scoliosis (°)

  Radiographic parameters measured on X-ray by Surgimap: the angle of the major curve in coronal X-ray

  2 years after operation

• Cobb angle of kyphosis (°)

  Radiographic parameters measured on X-ray by Surgimap: the angle of the kyphosis in sagittal X-ray

  2 years after operation

• Coronal balance (mm)

  Radiographic parameters measured on X-ray by Surgimap: the distance between C7PL and CSVL in coronal X-ray

  2 years after operation

• Sagittal balance (mm)

  Radiographic parameters measured on X-ray by Surgimap: the distance between C7PL and the posterior edge of sacrum in sagittal X-ray

  2 years after operation

• Rod broken rate (%)

  The ratio: number of patients with rod broken/ number of patients received surgery

  2 years after operation

• Screw broke rate(%)

  The ratio: number of patients with screw broken/ number of patients received surgery

  2 years after operation

• Coronal decompensation rate(%)

  The ratio: number of patients with coronal decompensation / number of patients received surgery

  2 years after operation

• Sagittal decompensation(%)

  The ratio: number of patients with sagittal decompensation / number of patients received surgery

  2 years after operation

• Short form-36 health survey（SF-36）

  SF-36 were calculated, including physical functioning, role physical, bodily pain, general health, vitality,social functioning, role-emotional and mental health.The SF-36 score is expressed as a number between 0 and 100. The higher the number, the better the health outcome.

  2 years after operation

Study Arms (3)

the double-rod group

EXPERIMENTAL

posterior spinal corrective surgery with osteotomy (two rods without dual-headed screw)

Procedure: double rods without dual-headed screw

the three-rod group

EXPERIMENTAL

posterior spinal corrective surgery with osteotomy (three rods with one dual-headed screw)

Procedure: three rods with one dual-headed screw

the four-rod group

EXPERIMENTAL

posterior spinal corrective surgery with osteotomy (four rods with two dual-headed screws)

Procedure: four rods with two dual-headed screw

Interventions

double rods without dual-headed screw PROCEDURE

adult patients with severe spinal deformity who underwent PSO osteotomy and posterior spinal corrective surgery with traditional double rods (No dual-headed screw used)

the double-rod group

three rods with one dual-headed screw PROCEDURE

adult patients with severe spinal deformity who underwent PSO osteotomy and posterior spinal corrective surgery with three rods (one dual-headed screw used in unilateral side)

the three-rod group

four rods with two dual-headed screw PROCEDURE

adult patients with severe spinal deformity who underwent PSO osteotomy and posterior spinal corrective surgery with four rods (two dual-headed screw used in bilateral side)

the four-rod group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• receive spinal corrective surgery from 2015-2020
• Age: 18-70 years old
• the Cobb angle of scoliosis or kyphosis more than 70 °
• posterior pedicle subtraction osteotomy(PSO), using novel duet screws in three-rod or four-rod group
• follow-up more than 24 months

You may not qualify if:

• previously received spinal surgery
• clinical and radiographic data preoperatively, postoperatively and last follow up were incomplete

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (7)

• Kim KT, Lee SH, Suk KS, Lee JH, Jeong BO. Outcome of pedicle subtraction osteotomies for fixed sagittal imbalance of multiple etiologies: a retrospective review of 140 patients. Spine (Phila Pa 1976). 2012 Sep 1;37(19):1667-75. doi: 10.1097/BRS.0b013e3182552fd0.

  PMID: 22433502 BACKGROUND

• Zhang Y, Hai Y, Tao L, Yang J, Zhou L, Yin P, Pan A, Zhang Y, Liu C. Posterior Multiple-Level Asymmetrical Ponte Osteotomies for Rigid Adult Idiopathic Scoliosis. World Neurosurg. 2019 Jul;127:e467-e473. doi: 10.1016/j.wneu.2019.03.173. Epub 2019 Mar 25.

  PMID: 30922897 BACKGROUND

• Suk SI, Kim JH, Kim WJ, Lee SM, Chung ER, Nah KH. Posterior vertebral column resection for severe spinal deformities. Spine (Phila Pa 1976). 2002 Nov 1;27(21):2374-82. doi: 10.1097/00007632-200211010-00012.

  PMID: 12438987 BACKGROUND

• Smith JS, Shaffrey CI, Ames CP, Demakakos J, Fu KM, Keshavarzi S, Li CM, Deviren V, Schwab FJ, Lafage V, Bess S; International Spine Study Group. Assessment of symptomatic rod fracture after posterior instrumented fusion for adult spinal deformity. Neurosurgery. 2012 Oct;71(4):862-7. doi: 10.1227/NEU.0b013e3182672aab.

  PMID: 22989960 BACKGROUND

• Scheer JK, Tang JA, Deviren V, Buckley JM, Pekmezci M, McClellan RT, Ames CP. Biomechanical analysis of revision strategies for rod fracture in pedicle subtraction osteotomy. Neurosurgery. 2011 Jul;69(1):164-72; discussion 172. doi: 10.1227/NEU.0b013e31820f362a.

  PMID: 21336218 BACKGROUND

• Zhu ZZ, Chen X, Qiu Y, Chen ZH, Li S, Xu L, Sun X. Adding Satellite Rods to Standard Two-rod Construct With the Use of Duet Screws: An Effective Technique to Improve Surgical Outcomes and Preventing Proximal Junctional Kyphosis in Posterior-Only Correction of Scheuermann Kyphosis. Spine (Phila Pa 1976). 2018 Jul 1;43(13):E758-E765. doi: 10.1097/BRS.0000000000002489.

  PMID: 29189571 BACKGROUND

• He Z, Chen Y, Liu Z, Yang B, Shi B, Wang Y, Feng Z, Zhang T, Chen X, Qiu Y, Qin X, Zhu Z. Biomechanical Advantages of Novel Duet Screws Plus Bilateral Satellite Rods Fixation in the Correction Surgery for Adult Spinal Deformity. Orthop Surg. 2025 Aug;17(8):2454-2466. doi: 10.1111/os.70121. Epub 2025 Jul 16.

  PMID: 40667831 DERIVED

Study Officials

• Lili Sha, Ph.D

  Medical Ethics Committee of Drum Tower Hospital affiliated to Nanjing University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Xiaodong Qin, Ph.D

CONTACT

008615298386726; qinxd_njumed@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: November 22, 2023
• Study Start: January 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 22, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)