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

Pelvic Pain Clinical Trial

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 Clinical Tests and Detection of Sacroiliac Instability Using RSA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900601
• Other study ID #: UUS nr: 28125409
• Secondary ID: REK: 1.2006.1574
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: June 2011

Study information

• Verified date: September 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Instability
• Pelvic Girdle Pain
• Pelvic Joint Instability
• Pelvic Pain

Intervention

Procedure:
• Arthrodesis to the sacroiliac joint and symphysis
Standard surgical procedures will be used. When the patient has isolated pain in the symphysis isolated fixation will be performed. A 2x2 cm large bone block will be removed and replaced with spongy bone. For fixation the Matta-plate will be applied. To the sacroiliac joint we use an anterior approach. A 2x1,5 cm large bone block will be removed and replaced with spongy bone from the iliac crest. For joint fixation we either use 2 plates or sacroiliac screws. The same procedure will be used on the other side in the cases with bilateral symptoms. Only one side will be operated at a time. After one year it will be decided if it's necessary to perform contralateral surgery.

Locations

Country	Name	City	State
Norway	Oslo university hospital - Ulllevaal	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI)	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.	12 months
Primary	Visual Analogue Scale (VAS) 0 to 10	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.	12 months
Secondary	Healing Measured by CT	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.	12 months