CLINICAL STUDY ON SPINAL FUSION WITH PATIENT SPECIFIC GUIDE-BASED CBT-SCREW VERSUS STANDARD FREE-HAND PEDICLE SCREW TECHNIQUE

Not Applicable

Recruiting

• Conditions: M43.0; M43; Spondylolysis; Other deforming dorsopathies

• Registration Number: DRKS00031623
• Lead Sponsor: Medacta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

•Patients who are willing and able to provide written informed consent for enrolment into the study. Written informed consent must be obtained prior to the patient’s surgery,
•Patients who are in need of a surgical instrumentation of the lumbar spine aimed at segmental fusion by means of posterior stabilization through pedicle screws and intersomatic cage (spondylodesis). Accepted levels are from L1 to S1.

Exclusion Criteria

•Pediatric patients (<18yrs)
•Severe active medical or psychiatric co-morbidities that would limit study participation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bony fusion (%)

Secondary Outcome Measures

Name	Time	Method
Pain, Quality of Life, Patient satisfaction