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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:
ClinicalTrials.gov Identifier:
NCT00900601
First Posted: May 13, 2009
Last Update Posted: October 12, 2017
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.
Collaborators:
Oslo University Hospital
Stiftelsen Helse og Rehabilitering
Information provided by:
Oslo University Hospital
  Purpose

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.


Condition Intervention
Pelvic Joint Instability Pelvic Pain Procedure: Arthrodesis to the sacroiliac joint and symphysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Oswestry Disability Index (ODI) [ Time Frame: 3,6,12 months ]
  • Visual Analogue Scale (VAS) 0 to 10 [ Time Frame: 3,6,12 months ]

Secondary Outcome Measures:
  • SF-36 [ Time Frame: 3,6,12 months ]
  • Healing measured by CT [ Time Frame: 3,6,12 months ]

Estimated Enrollment: 20
Study Start Date: January 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900601


Locations
Norway
Oslo university hospital - Ulllevaal
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Oslo University Hospital
Stiftelsen Helse og Rehabilitering
Investigators
Principal Investigator: Thomas J Kibsgaard, PhD student Oslo university hosptal - Ullevaal
  More Information

Responsible Party: Thomas Johan Kibsgaard, Oslo university hospital - Ullevaal
ClinicalTrials.gov Identifier: NCT00900601     History of Changes
Other Study ID Numbers: UUS nr: 28125409
REK: 1.2006.1574
First Submitted: May 11, 2009
First Posted: May 13, 2009
Last Update Posted: October 12, 2017
Last Verified: August 2011

Keywords provided by Oslo University Hospital:
Sacroiliac pain
Sacroiliac instability
Pelvic girdle pain
Sacroiliac arthrodesis
Arthrodesis
Surgery

Additional relevant MeSH terms:
Pelvic Pain
Pelvic Girdle Pain
Joint Instability
Pain
Neurologic Manifestations
Signs and Symptoms
Musculoskeletal Pain
Nervous System Diseases
Joint Diseases
Musculoskeletal Diseases