Text Size

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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 11, 2009
Last Updated: August 8, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Joint Instability
Pelvic Pain
Joint Diseases
 Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013