Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma
Primary Purpose
Pelvic Joint Instability, Pelvic Pain
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Arthrodesis to the sacroiliac joint and symphysis
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Joint Instability focused on measuring Sacroiliac pain, Sacroiliac instability, Pelvic girdle pain, Sacroiliac arthrodesis, Arthrodesis, Surgery
Eligibility 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
Sites / Locations
- Oslo university hospital - Ulllevaal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sacroilliac fusion
Arm Description
Pastient are treated with sacroiliac joint arthrodesis to the sacroiliac joint and symphysis
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Healing Measured by CT
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.
Full Information
NCT ID
NCT00900601
First Posted
May 11, 2009
Last Updated
September 18, 2017
Sponsor
Oslo University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering
1. Study Identification
Unique Protocol Identification Number
NCT00900601
Brief Title
Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma
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 Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Joint Instability, Pelvic Pain
Keywords
Sacroiliac pain, Sacroiliac instability, Pelvic girdle pain, Sacroiliac arthrodesis, Arthrodesis, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sacroilliac fusion
Arm Type
Experimental
Arm Description
Pastient are treated with sacroiliac joint arthrodesis to the sacroiliac joint and symphysis
Intervention Type
Procedure
Intervention Name(s)
Arthrodesis to the sacroiliac joint and symphysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
12 months
Title
Visual Analogue Scale (VAS) 0 to 10
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Healing Measured by CT
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Kibsgaard, PhD student
Organizational Affiliation
Oslo university hosptal - Ullevaal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo university hospital - Ulllevaal
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma
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