Observational multicenter study for minimally invasive sacroiliac joint fusion in patients with sacroiliac joint dysfunction.

Independent multicenter observational study of minimally invasive sacroiliac joint fusion for sacroiliac joint dysfunction.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23679

Enrollment

Registered

2021-03-19

Start date

2021-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Sacroiliac joint dysfunction

Interventions

MISJF

Eligibility

Inclusion criteria

Inclusion criteria: In order for patients to be eligible to participate in this study, a subject must meet all of the following criteria: - 18 years or older - Proven SIJ dysfunction with at least a 50% decrease of pain after image-guided injection into the SIJ with local anesthetic - Indication for MISJF

Exclusion criteria

Exclusion criteria: A potential patient who meets any of the following criteria will be excluded from participation in this study: - Previous SIJ surgery on the affected side - No documented preoperative VAS, ODI and EQ-5D-3L score (retrospective series)

Design outcomes

Primary

Measure	Time frame
pain, disability and health-related quality of life	—

Secondary

Measure	Time frame
Complications, as a result of surgery, are defined as reoperation, postoperative infection, deep venous thrombosis, hematoma, hardware failure, implant mispositioning, neurological deficits and other complications as pneumonia or urinary tract infection. All complications will be reported and defined as adverse events (AE’s) or serious adverse events (SAE’s). Further explained in the safety reporting. Also, demographic baseline characteristics (e.g. age, ASA classification, gender) will be obtained for analyzation.	—

Measure

Time frame

Complications, as a result of surgery, are defined as reoperation, postoperative infection, deep venous thrombosis, hematoma, hardware failure, implant mispositioning, neurological deficits and other complications as pneumonia or urinary tract infection. All complications will be reported and defined as adverse events (AE’s) or serious adverse events (SAE’s). Further explained in the safety reporting. Also, demographic baseline characteristics (e.g. age, ASA classification, gender) will be obtained for analyzation.

—

Contacts

Public ContactSem Hermans

Zuyderland Medical Center

se.hermans@zuyderland.nl+31627453199

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)