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

This study has been completed.
Sponsor:
Collaborators:
Oslo University Hospital
Stiftelsen Helse og Rehabilitering
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00900601
First received: May 11, 2009
Last updated: August 8, 2011
Last verified: August 2011
History of Changes

May 11, 2009
August 8, 2011
January 2007
June 2011   (final data collection date for primary outcome measure)
  • Oswestry Disability Index (ODI) [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
  • Visual Analogue Scale (VAS) 0 to 10 [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00900601 on ClinicalTrials.gov Archive Site
  • SF-36 [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
  • Healing measured by CT [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma
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.

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pelvic Joint Instability
  • Pelvic Pain
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00900601
UUS nr: 28125409, REK: 1.2006.1574
Yes
Thomas Johan Kibsgaard, Oslo university hospital - Ullevaal
Ullevaal University Hospital
  • Oslo University Hospital
  • Stiftelsen Helse og Rehabilitering
Principal Investigator: Thomas J Kibsgaard, PhD student Oslo university hosptal - Ullevaal
Oslo University Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP