N/A
N=9
Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma
Pelvic Joint Instability · Pelvic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00900601 ↗Enrolled (actual)
9
Serious AEs
12.5%
Results posted
May 2018
Primary outcome: Primary: Oswestry Disability Index (ODI) — 54; 37 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arthrodesis to the sacroiliac joint and symphysis (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Oslo University Hospital
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oswestry Disability Index (ODI) |
54; 37 | — |
| PRIMARY Visual Analogue Scale (VAS) 0 to 10 |
81; 57 | — |
| SECONDARY Healing Measured by CT |
8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00900601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.