Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| REK: 1.2006.1574 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stiftelsen Helse og Rehabilitering | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacroilliac fusion | Experimental | Pastient are treated with sacroiliac joint arthrodesis to the sacroiliac joint and symphysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas J Kibsgaard, PhD student | Oslo university hosptal - Ullevaal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo university hospital - Ulllevaal | Oslo | 0407 | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sacroliac Joint Fusion | Patients treated with sacroiliac joint fusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sacroliac Joint Fusion | Patients treated with sacroiliac joint fusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sacroliac Joint Fusion | Patients treated with sacroiliac joint fusion | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nerve damage | Nervous system disorders | Systematic Assessment | Nervedamage to the lumbosacral plexus |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient sensitivity loss to the lateral femoral cutaneous nerve | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Kibsgård | Oslo University Hospital | 99030831 | +47 | kibsgard@gmail.com |
Not provided
| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| D059388 | Pelvic Girdle Pain |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of pain | Median | Full Range | years |
|
| BMI | Median | Full Range | kg/m2 |
|
| Etiology | Count of Participants | Participants |
|
| Unilateral/Bilateral | Count of Participants | Participants |
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 8 |
| 1 |
| 8 |
| 3 |
| 8 |
|
| Infection | Infections and infestations | Systematic Assessment | Deep wound infection |
|
| Loss of bladder sensation | Nervous system disorders | Systematic Assessment | Loss of bladder sensation |
|
Not provided
Not provided
| D059352 | Musculoskeletal Pain |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |