Single-center comparison for the efficacy and safety of posterior cervical single-door open laminoplasty with mini-titanium plate fixation and posterior cervical double-door open laminoplasty with lateral mass screw fixation and fusion in the treatment of Ossification of Posterior Longitudinal Ligament ( OPLL )

• Register: ChiCTR
• Last refreshed on: 14 January 2019
• Main ID: ChiCTR1800020231
• Date of registration: 2018-12-20
• Prospective Registration: No
• Primary sponsor: Shandong provincial hospital affiliated to Shandong university
• Public title: Single-center comparison for the efficacy and safety of posterior cervical single-door open laminoplasty with mini-titanium plate fixation and posterior cervical double-door open laminoplasty with lateral mass screw fixation and fusion in the treatment of Ossification of Posterior Longitudinal Ligament ( OPLL )
• Scientific title: Single-center comparison for the efficacy and safety of posterior cervical single-door open laminoplasty with mini-titanium plate fixation and posterior cervical double-door open laminoplasty with lateral mass screw fixation and fusion in the treatment of Ossification of Posterior Longitudinal Ligament ( OPLL )
• Date of first enrolment: 2017-12-01
• Target sample size: A:31;B:31;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=34089
• Study type: Observational study
• Study design: Non randomized control
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Shijie Han
• Affiliation: Shandong provincial hospital affiliated to Shandong university

• Name: Kai Fu
• Affiliation: Shandong provincial hospital affiliated to Shandong university

Key inclusion & exclusion criteria

Inclusion criteria: 1) patients aged 18-65 years, without gender limitation, are willing to sign informed consent;
2) patients diagnosed with OPLL,CT showed that the compression of the posterior longitudinal ligament ossification involve more than 3 spinal segments;
3) patients presented with limbs numbness, walking instability, or other spinal cord, nerve root compression symptoms, which may be associated with OPLL;
4)Conservative treatment is invalid.
Exclusion criteria: 1) Cervical ligamentous ossification, cervical trauma, cervical cancer, cervical tuberculosis and other inflammatory diseases;
2) accompanied by other spine parts of the disease affect the clinical symptoms of patients;
3) associated with amyotrophic lateral sclerosis and other motor neuron diseases and other neurological diseases;
4) poor health condition, unable to tolerate surgery;
5) patients (or their guardians) can not give full informed consent for adult dysfunction;
6) patients who have participated in other clinical trials in the past 1 month;
7) patients with active hepatitis B (including HBeAg) or serological markers (HBsAg or / and HBeAg or / and HBcAb), hepatitis C, tuberculosis, cytomegalovirus infection, severe fungal infection, HIV infection or patients with Turmor.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Ossification of Posterior Longitudinal Ligament ( OPLL )

Intervention(s)

A:Posterior cervical single-door open laminoplasty with mini-titanium plate fixation;B:Posterior cervical double-door open laminoplasty with lateral mass screw fixation and fusion;

Primary Outcome(s)

JOA scale;Ossification progress;

Secondary Outcome(s)

Neck disability index;visual analogue scale;curvature index;Incidence rate of C5 root palsy;C2-C7 SVA;

Source(s) of Monetary Support

NA

Ethics review

Status: Not approved
Approval date: 26/08/2013
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