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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023797

Enrollment

Registered

2020-12-07

Start date

2020-12-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S32

Interventions

Group 1: Patients who have received a medical recommendation for a SACRONAIL implant are examined at different times before and after surgery. The maintenance / improvement of the quality of life, pat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. 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. 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.	—

Measure

Time frame

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. 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. 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

Measure	Time frame
Three different secondary endpoints for assessing efficiency were defined: 1. Maintaining / improving the patient's quality of life and patient satisfaction. (SF-12, WET PI) 2. The functionality of the pelvic ring. (Majeed Score, Pelvic Outcome Scale) 3. The stabilization of the pelvic ring. 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)	—

Measure

Time frame

Three different secondary endpoints for assessing efficiency were defined: 1. Maintaining / improving the patient's quality of life and patient satisfaction. (SF-12, WET PI) 2. The functionality of the pelvic ring. (Majeed Score, Pelvic Outcome Scale) 3. The stabilization of the pelvic ring. 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)

—

Countries

Germany

Contacts

Public ContactIsabell Hock

SIGNUS Medizintechnik GmbH

i.hock@signus.com060239166178

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026