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

NCT00900601 | Completed Results DMC

• 2 other identifiers: UUS nr: 28125409REK: 1.2006.1574
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Joint Instability; Pelvic Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Oswestry Disability Index (ODI)

  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.

  12 months

• Visual Analogue Scale (VAS) 0 to 10

  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.

  12 months

Secondary Outcomes (1)

• Healing Measured by CT

  12 months

Study Arms (1)

Sacroilliac fusion

EXPERIMENTAL

Pastient are treated with sacroiliac joint arthrodesis to the sacroiliac joint and symphysis

Procedure: Arthrodesis to the sacroiliac joint and symphysis

Interventions

Arthrodesis to the sacroiliac joint and symphysis PROCEDURE

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.

Sacroilliac fusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain in one or more pelvic joints.
• Minimum 2 positive clinical tests.
• High pain and disability score
• Tried adequate physiotherapy without effect.

You may not qualify if:

• Known psychiatric diagnosis
• Other spine pathology
• CT verified ankylosis
• BMI\>30

Sponsors & Collaborators

• Oslo University Hospital: lead
• Stiftelsen Helse og Rehabilitering: collaborator

Study Sites (1)

Oslo university hospital - Ulllevaal

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

Pelvic Pain; Pelvic Girdle Pain; Ankylosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Pain; Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Thomas Kibsgård
• Organization: Oslo University Hospital

kibsgard@gmail.com

99030831

Study Officials

• Thomas J Kibsgaard, PhD student

  Oslo university hosptal - Ullevaal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: January 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 29, 2018
• Results First Posted: May 29, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)