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

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ClinicalTrials.gov Identifier: NCT00900601
Recruitment Status : Completed
First Posted : May 13, 2009
Results First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by (Responsible Party):
Thomas Johan Kibsgård, Oslo University Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pelvic Joint Instability
Pelvic Pain
Intervention Procedure: Arthrodesis to the sacroiliac joint and symphysis
Enrollment 9
Recruitment Details During the study period, from 2007 and 2010, a total of 20 patients with PGP were referred Oslo University Hospital, but only 9 patients met the study’s inclusion criteria.
Pre-assignment Details  
Arm/Group Title Sacroliac Joint Fusion
Hide Arm/Group Description Patients treated with sacroiliac joint fusion
Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title Sacroliac Joint Fusion
Hide Arm/Group Description Patients treated with sacroiliac joint fusion
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
40
(33 to 47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
9
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
9
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 9 participants
9
Duration of pain  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
11
(2 to 25)
BMI  
Median (Full Range)
Unit of measure:  Kg/m2
Number Analyzed 9 participants
25
(20 to 30)
Etiology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Post preganancy
7
  77.8%
Trauma
2
  22.2%
Unilateral/Bilateral  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Unilateral pain
1
  11.1%
Bilateral pain
8
  88.9%
1.Primary Outcome
Title Oswestry Disability Index (ODI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sacroliac Joint Fusion
Hide Arm/Group Description:
Patients treated with sacroiliac joint fusion
Overall Number of Participants Analyzed 8
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Baseline
54
(48 to 60)
One year
37
(34 to 40)
2.Primary Outcome
Title Visual Analogue Scale (VAS) 0 to 10
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sacroliac Joint Fusion
Hide Arm/Group Description:
Patients treated with sacroiliac joint fusion
Overall Number of Participants Analyzed 8
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Baseline
81
(76 to 87)
One year
57
(49 to 61)
3.Secondary Outcome
Title Healing Measured by CT
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sacroliac Joint Fusion
Hide Arm/Group Description:
Patients treated with sacroiliac joint fusion
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sacroliac Joint Fusion
Hide Arm/Group Description Patients treated with sacroiliac joint fusion
All-Cause Mortality
Sacroliac Joint Fusion
Affected / at Risk (%)
Total   0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Sacroliac Joint Fusion
Affected / at Risk (%) # Events
Total   1/8 (12.50%)    
Infections and infestations   
Infection  [1]  1/8 (12.50%)  1
Nervous system disorders   
Nerve damage  [2]  1/8 (12.50%)  1
Loss of bladder sensation  [3]  1/8 (12.50%)  1
Indicates events were collected by systematic assessment
[1]
Deep wound infection
[2]
Nervedamage to the lumbosacral plexus
[3]
Loss of bladder sensation
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sacroliac Joint Fusion
Affected / at Risk (%) # Events
Total   3/8 (37.50%)    
Nervous system disorders   
Transient sensitivity loss to the lateral femoral cutaneous nerve   3/8 (37.50%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Kibsgård
Organization: Oslo University Hospital
Phone: 99030831 ext +47
EMail: kibsgard@gmail.com
Layout table for additonal information
Responsible Party: Thomas Johan Kibsgård, Oslo University Hospital
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
Results First Submitted: March 15, 2017
Results First Posted: May 28, 2018
Last Update Posted: May 28, 2018