ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00900601
Recruitment Status : Completed
First Posted : May 13, 2009
Results First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by (Responsible Party):
Thomas Johan Kibsgård, Oslo University Hospital

May 11, 2009
May 13, 2009
March 15, 2017
May 28, 2018
May 28, 2018
January 2007
June 2011   (Final data collection date for primary outcome measure)
  • Oswestry Disability Index (ODI) [ Time Frame: 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 [ Time Frame: 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.
  • Oswestry Disability Index (ODI) [ Time Frame: 3,6,12 months ]
  • Visual Analogue Scale (VAS) 0 to 10 [ Time Frame: 3,6,12 months ]
Complete list of historical versions of study NCT00900601 on ClinicalTrials.gov Archive Site
Healing Measured by CT [ Time Frame: 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.
  • SF-36 [ Time Frame: 3,6,12 months ]
  • Healing Measured by CT [ Time Frame: 3,6,12 months ]
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 Applicable
Intervention Model: Single Group Assignment
Masking: None (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.

Experimental: Sacroilliac fusion
Pastient are treated with sacroiliac joint arthrodesis to the sacroiliac joint and symphysis
Intervention: Procedure: Arthrodesis to the sacroiliac joint and symphysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00900601
UUS nr: 28125409
REK: 1.2006.1574
Yes
Not Provided
Plan to Share IPD: No
Thomas Johan Kibsgård, Oslo University Hospital
Oslo University Hospital
Stiftelsen Helse og Rehabilitering
Principal Investigator: Thomas J Kibsgaard, PhD student Oslo university hosptal - Ullevaal
Oslo University Hospital
September 2017

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