Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma

Not Applicable

Completed

• Conditions: Pelvic Pain; Pelvic Joint Instability
• Interventions: Procedure: Arthrodesis to the sacroiliac joint and symphysis

• Registration Number: NCT00900601
• Lead Sponsor: Oslo University Hospital

Brief Summary

Pelvic girdle pain (PGP) related to pregnancy is a common reason to sick leave during pregnancy. Low back pain and PGP affects about 50% of women during pregnancy. Most of the women recover, however about 10% of the women still have complaints after birth. Most patients have positive effect from conservative treatment, but unfortunately some do still have much pain despite intensive conservative rehabilitation. Surgery has been tried on these women with various results. Surgical treatment is controversial and there is a lack of documentation. The investigators will operate 20 patients with arthrodesis to the sacroiliac joint and symphysis. Radiostereometric analysis (RSA) will be used to evaluate the joint movement in different part of the process.

Hypothesis: Severe pelvic girdle pain is caused by pelvic joint instability in some cases and surgically fixation of the affected joints can help these women to get back to a normal life.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2017-03-15
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-18
• Last Update Submitted: 2017-09-18
• Results First Posted: 2018-05-29
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Pain in one or more pelvic joints.
• Minimum 2 positive clinical tests.
• High pain and disability score
• Tried adequate physiotherapy without effect.

Exclusion Criteria

• Known psychiatric diagnosis
• Other spine pathology
• CT verified ankylosis
• BMI>30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sacroilliac fusion	Arthrodesis to the sacroiliac joint and symphysis	Pastient are treated with sacroiliac joint arthrodesis to the sacroiliac joint and symphysis

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	12 months	Oswestry Disability Index is a 10 item questionnaire comprises 10 questions about physical function. Each item has a 0-5 scale and the raw score is multiplied by 2 and the sum is the total score. Zero represents excellent physical function and 100 is more or less bedridden. This is the most used outcome measure in low back pain studies.
Visual Analogue Scale (VAS) 0 to 10	12 months	Visual Analogue Scale is a 0 -10 scale. Zero is no pain and 10 is the worst pain you can imagine. In this study the patients were asked to report the morgning and evening pain by this scale.

Secondary Outcome Measures

Name	Time	Method
Healing Measured by CT	12 months	Number of participants with healing as measured by CT data. The outcome was radiological healing vs no signs of radiological healing. In order to be classified as healed the CT scans had to show Clear signs of bone bridging across the sacroiliac joint.

Trial Locations

Locations (1)

Oslo university hospital - Ulllevaal; 🇳🇴 Oslo, Norway