Trial Outcomes & Findings for Sacroiliac (SI) Screws: The Effect of SI Screw Removal on Patient-Reported Pain and Functional Outcomes (NCT NCT02652611)

Last Updated: 2024-10-09

Results Overview

The BPI is presented on a 0-10 level visual analog scale with a 24-hour recall period. A level of 0 is described to the patients as "no pain," and "10" described as "pain as bad as you can imagine." The BPI includes four items: the worst pain the patient has felt in the last 24 hours, the least pain the patient has felt in the last 24 hours, the average pain the patient has felt in the last 24 hours, and the pain the patient feels right now. The BPI score is the average of the four items.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Up to 24 months post initial SI screw stabilization

Results posted on

2024-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Screw Removal Patients enrolled in the SI screw removal treatment group will undergo the surgery 5-9 months after the initial SI screw stabilization surgery. The surgeon will remove all screws that he/she is able and feels is appropriate for the patient. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms. SI Screw Removal Surgery	Non-screw Removal Patients enrolled in the Non-SI screw removal treatment group will not undergo surgical intervention to for removal of their SI screws. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If complications arise and/or the patient requires screw removal surgery, crossover will be allowed and recorded within study follow up forms. Non-screw removal treatment (non-operative management)
Overall Study STARTED	15	45
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Based on the limited enrollment in the trial and the high rate of treatment crossover in the trial, we pooled the randomized trial and observational patients for this analysis. To mitigate this bias, we matched patients who underwent iliosacral screw removal to a control group of patients who retained their iliosacral screws.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Screw Removal n=14 Participants Patients enrolled in the SI screw removal treatment group will undergo the surgery 5-9 months after the initial SI screw stabilization surgery. The surgeon will remove all screws that he/she is able and feels is appropriate for the patient. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms. SI Screw Removal Surgery	Non-screw Removal n=14 Participants Patients enrolled in the Non-SI screw removal treatment group will not undergo surgical intervention to for removal of their SI screws. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If complications arise and/or the patient requires screw removal surgery, crossover will be allowed and recorded within study follow-up forms. Non-screw removal treatment (non-operative management)	Total n=28 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 16 • n=5 Participants • Based on the limited enrollment in the trial and the high rate of treatment crossover in the trial, we pooled the randomized trial and observational patients for this analysis. To mitigate this bias, we matched patients who underwent iliosacral screw removal to a control group of patients who retained their iliosacral screws.	34 years STANDARD_DEVIATION 13 • n=7 Participants • Based on the limited enrollment in the trial and the high rate of treatment crossover in the trial, we pooled the randomized trial and observational patients for this analysis. To mitigate this bias, we matched patients who underwent iliosacral screw removal to a control group of patients who retained their iliosacral screws.	39 years STANDARD_DEVIATION 14.5 • n=5 Participants • Based on the limited enrollment in the trial and the high rate of treatment crossover in the trial, we pooled the randomized trial and observational patients for this analysis. To mitigate this bias, we matched patients who underwent iliosacral screw removal to a control group of patients who retained their iliosacral screws.
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	54 participants n=5 Participants
fracture classification Anterior Posterior Compression 1 (APC1)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
fracture classification Anterior Posterior Compression 2 (APC 2)	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
fracture classification Anterior Posterior Compression 3 (APC 3)	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
fracture classification Lateral Compression 1 (LC 1)	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
fracture classification Lateral Compression 2 (LC 2)	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
fracture classification Lateral Compression 3 (LC 3)	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Area Deprivation Index	40 units on a scale STANDARD_DEVIATION 18 • n=5 Participants	49 units on a scale STANDARD_DEVIATION 27 • n=7 Participants	44.5 units on a scale STANDARD_DEVIATION 22.5 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 months post initial SI screw stabilization

Population: The study included patients aged 18-80 years with an unstable posterior pelvic ring fracture who underwent open or closed reduction and internal fixation with iliosacral screws. For inclusion, patients were screened for postoperative pain at a clinic visit between 4 and 8 months after their initial surgery.

Outcome measures

Outcome measures
Measure	Screw Removal n=14 Participants Patients enrolled in the SI screw removal treatment group will undergo the surgery 5-9 months after the initial SI screw stabilization surgery. The surgeon will remove all screws that he/she is able and feels is appropriate for the patient. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms. SI Screw Removal Surgery	Non-screw Removal n=14 Participants Patients enrolled in the Non-SI screw removal treatment group will not undergo surgical intervention to for removal of their SI screws. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If complications arise and/or the patient requires screw removal surgery, crossover will be allowed and recorded within study follow0up forms. Non-screw removal treatment (non-operative management)
Post-operative Pain Within 6 Months After Iliosacral Screw Removal Using the Brief Pain Inventory (BPI)	3.7 units on a scale Standard Deviation 2.7	4.7 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Up to 24 months post initial SI screw stabilization

Population: The study included patients aged 18-80 years with an unstable posterior pelvic ring fracture who underwent open or closed reduction and internal fixation with iliosacral screws.

The Majeed Pelvic Outcome Score is a clinically validated tool that assesses pain, working status, walking distance, sitting, sexual intercourse, walking aids, unaided gait, and walking distance. The score is reported on a 0-100 point scale with higher values indicating better pelvic function.

Outcome measures

Outcome measures
Measure	Screw Removal n=14 Participants Patients enrolled in the SI screw removal treatment group will undergo the surgery 5-9 months after the initial SI screw stabilization surgery. The surgeon will remove all screws that he/she is able and feels is appropriate for the patient. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms. SI Screw Removal Surgery	Non-screw Removal n=14 Participants Patients enrolled in the Non-SI screw removal treatment group will not undergo surgical intervention to for removal of their SI screws. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If complications arise and/or the patient requires screw removal surgery, crossover will be allowed and recorded within study follow0up forms. Non-screw removal treatment (non-operative management)
Pelvic Function Within 6 Months After Iliosacral Screw Removal, Measured Using the Majeed Pelvic Outcome Score.	68.3 score on a scale of 0-100 Standard Deviation 17.8	63.6 score on a scale of 0-100 Standard Deviation 23.6

Adverse Events

Screw Removal

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-screw Removal

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Screw Removal n=14 participants at risk Patients enrolled in the SI screw removal treatment group will undergo the surgery 5-9 months after the initial SI screw stabilization surgery. The surgeon will remove all screws that he/she is able and feels is appropriate for the patient. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms. SI Screw Removal Surgery	Non-screw Removal n=14 participants at risk Patients enrolled in the Non-SI screw removal treatment group will not undergo surgical intervention to for removal of their SI screws. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If complications arise and/or the patient requires screw removal surgery, crossover will be allowed and recorded within study follow-up forms. Non-screw removal treatment (non-operative management)
Infections and infestations Bacteremia	0.00% 0/14 • 24 months following surgery and enrollment into study The definitions do not differ.	7.1% 1/14 • Number of events 3 • 24 months following surgery and enrollment into study The definitions do not differ.
Musculoskeletal and connective tissue disorders Unplanned surgery	7.1% 1/14 • Number of events 1 • 24 months following surgery and enrollment into study The definitions do not differ.	0.00% 0/14 • 24 months following surgery and enrollment into study The definitions do not differ.

Other adverse events

Adverse event data not reported

Additional Information

Haley Demyanovich

U Maryland

Phone: 4107063935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place