An interventional study of Arthrodesis to the sacroiliac joint and symphysis in Pelvic Joint Instability and Pelvic Pain, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2018-05-29.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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.
147 studies on the registry are indexed under Joint Instability; 22 are open to participants now.
This study's enrollment of 9 is below the median of 42 across 80 interventional studies indexed under Joint Instability.
Browse Joint Instability studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 12 months
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.
| Milestone | Sacroliac Joint Fusion |
|---|---|
| Started | 9 |
| Completed | 8 |
| Not completed | 1 |
| Withdrew: Physician decision | 1 |
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.
| units on a scale | Sacroliac Joint Fusion |
|---|---|
| Baseline | 54 (48 to 60) |
| One year | 37 (34 to 40) |
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.
| units on a scale | Sacroliac Joint Fusion |
|---|---|
| Baseline | 81 (76 to 87) |
| One year | 57 (49 to 61) |
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.
| Participants | Sacroliac Joint Fusion |
|---|---|
| Healing Measured by CT | 8 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sacroliac Joint Fusion | 0/8 (0%) | 1/8 (12.5%) | 3/8 (37.5%) |
| Event | Sacroliac Joint Fusion |
|---|---|
| Nerve damageNervous system disorders | 1/8 |
| InfectionInfections and infestations | 1/8 |
| Loss of bladder sensationNervous system disorders | 1/8 |
| Event | Sacroliac Joint Fusion |
|---|---|
| Transient sensitivity loss to the lateral femoral cutaneous nerveNervous system disorders | 3/8 |
| Age, Continuous(years) | Sacroliac Joint Fusion |
|---|---|
| Median | 40 (33 to 47) |
| Sex: Female, Male(Participants) | Sacroliac Joint Fusion |
|---|---|
| Female | 9 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Sacroliac Joint Fusion |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Sacroliac Joint Fusion |
|---|---|
| Norway | 9 |
| Duration of pain(years) | Sacroliac Joint Fusion |
|---|---|
| Median | 11 (2 to 25) |
| BMI(kg/m2) | Sacroliac Joint Fusion |
|---|---|
| Median | 25 (20 to 30) |
| Etiology(Participants) | Sacroliac Joint Fusion |
|---|---|
| Post preganancy | 7 |
| Trauma | 2 |
| Unilateral/Bilateral(Participants) | Sacroliac Joint Fusion |
|---|---|
| Unilateral pain | 1 |
| Bilateral pain | 8 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oslo University Hospital