Clinical Trial: Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma - A Study to Measure Effect of Surgery, Analysis of Cl
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 Summary:
Sponsor: Ullevaal University Hospital
Current Primary Outcome:
- Oswestry Disability Index (ODI) [ Time Frame: 3,6,12 months ]
- Visual Analogue Scale (VAS) 0 to 10 [ Time Frame: 3,6,12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- SF-36 [ Time Frame: 3,6,12 months ]
- Healing measured by CT [ Time Frame: 3,6,12 months ]
Original Secondary Outcome: Same as current
Information By: Oslo University Hospital
Dates:
Date Received: May 11, 2009
Date Started: January 2007
Date Completion:
Last Updated: August 8, 2011
Last Verified: August 2011
