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

• ClinicalTrials.gov Identifier: NCT00900601
• Recruitment Status: Completed
• First Posted: May 13, 2009
• Results First Posted: May 29, 2018
• Last Update Posted: May 29, 2018
• Sponsor: Oslo University Hospital
• Collaborator: Stiftelsen Helse og Rehabilitering
• Information provided by (Responsible Party): Thomas Johan Kibsgård, Oslo University Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pelvic Joint Instability; Pelvic Pain	Procedure: Arthrodesis to the sacroiliac joint and symphysis	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• 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.
• Study Start Date: January 2007
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: June 2011

Arms and Interventions

Arm

Intervention/treatment

Experimental: Sacroilliac fusion; Pastient are treated with sacroiliac joint arthrodesis to the sacroiliac joint and symphysis

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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

Locations

Norway

Oslo university hospital - Ulllevaal

Oslo, Norway, 0407

Sponsors and Collaborators

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 Kibsgård, Consultant, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT00900601
• Other Study ID Numbers: UUS nr: 28125409; REK: 1.2006.1574
• First Posted: May 13, 2009
• Results First Posted: May 29, 2018
• Last Update Posted: May 29, 2018
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Thomas Johan Kibsgård, Oslo University Hospital:

Sacroiliac pain; Sacroiliac instability; Pelvic girdle pain; Sacroiliac arthrodesis; Arthrodesis; Surgery

Additional relevant MeSH terms:

Joint Instability; Pelvic Pain; Pelvic Girdle Pain; Pain; Neurologic Manifestations; Musculoskeletal Pain; Joint Diseases; Musculoskeletal Diseases