Prospective evaluation of the dorsal stabilization of the pelvic ring with SACRONAIL in a heterogeneous group of patients

Recruiting

Conditions: S32
Fracture of lumbar spine and pelvis

Registration Number: DRKS00023797

Lead Sponsor: SIGNUS Medizintechnik GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Medical recommendation for the insertion of the SACRONAIL implant
- Age> 18 years

Exclusion Criteria

- Age <18 years
- Patients incapable of giving consent, e.g. due to cognitive limitations
- Pregnant and breastfeeding women
- Patients for whom there is no consent

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is to evaluate the clinical outcome one year after surgery. The clinical result is assessed with the evaluation system by Rommens et al (Rommens, et al., 2002). This scoring has already been used for traumatic (Rommens, et al., 2002) and geriatric patients (Mehling, et al., 2012) and is therefore considered appropriate.<br><br>Rommens, P. M. and Hessmann, M. H. 2002. Staged Reconstruction of Pelvic Ring Disruption: Differences in Morbidity, Mortality, Radiologic Results, and Functional Outcomes Between B1, B2 / B3, and C-Type Lesions. Journal of Orthopedic Trauma. 2002, pp. 92-98.<br><br>Mehling, I., Hessmann, M. H. and Rommens, P. M. 2012. Stabilization of fatigue fractures of the dorsal pelvis with a trans-sacral bar. Operative technique and outcome. Injury. 2012, pp. 446-451.

Secondary Outcome Measures

Name	Time	Method
Three different secondary endpoints for assessing efficiency were defined:<br>1. Maintaining / improving the patient's quality of life and patient satisfaction. (SF-12, WET PI)<br>2. The functionality of the pelvic ring. (Majeed Score, Pelvic Outcome Scale)<br>3. The stabilization of the pelvic ring.<br>Assessment of the safety of the implant and surgery is done by assessing the secondary endpoints. (Considering bone healing or the non-occurrence of a fracture)