Trial Outcomes & Findings for Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma (NCT NCT00900601)

Last Updated: 2018-05-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

12 months

Results posted on

2018-05-29

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Sacroliac Joint Fusion Patients treated with sacroiliac joint fusion
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sacroliac Joint Fusion Patients treated with sacroiliac joint fusion
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sacroliac Joint Fusion n=9 Participants Patients treated with sacroiliac joint fusion
Age, Continuous	40 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Norway	9 participants n=5 Participants
Duration of pain	11 years n=5 Participants
BMI	25 kg/m2 n=5 Participants
Etiology Post preganancy	7 Participants n=5 Participants
Etiology Trauma	2 Participants n=5 Participants
Unilateral/Bilateral Unilateral pain	1 Participants n=5 Participants
Unilateral/Bilateral Bilateral pain	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Sacroliac Joint Fusion n=8 Participants Patients treated with sacroiliac joint fusion
Oswestry Disability Index (ODI) Baseline	54 units on a scale Interval 48.0 to 60.0
Oswestry Disability Index (ODI) One year	37 units on a scale Interval 34.0 to 40.0

PRIMARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Sacroliac Joint Fusion n=8 Participants Patients treated with sacroiliac joint fusion
Visual Analogue Scale (VAS) 0 to 10 Baseline	81 units on a scale Interval 76.0 to 87.0
Visual Analogue Scale (VAS) 0 to 10 One year	57 units on a scale Interval 49.0 to 61.0

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Sacroliac Joint Fusion n=8 Participants Patients treated with sacroiliac joint fusion
Healing Measured by CT	8 Participants

Adverse Events

Sacroliac Joint Fusion

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sacroliac Joint Fusion n=8 participants at risk Patients treated with sacroiliac joint fusion
Nervous system disorders Nerve damage	12.5% 1/8 • Number of events 1 • 1 year
Infections and infestations Infection	12.5% 1/8 • Number of events 1 • 1 year
Nervous system disorders Loss of bladder sensation	12.5% 1/8 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Sacroliac Joint Fusion n=8 participants at risk Patients treated with sacroiliac joint fusion
Nervous system disorders Transient sensitivity loss to the lateral femoral cutaneous nerve	37.5% 3/8 • Number of events 3 • 1 year

Additional Information

Thomas Kibsgård

Oslo University Hospital

Phone: 99030831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place