Pain, Pelvis, Sacroiliac Joint
Conditions
Keywords
Screw Removal vs. Non-screw removal, Complications, SI Screw Stabilization
Brief summary
Chronic pain following surgical stabilization of a pelvic fracture is very prominent and can have a major affect on a patient's quality of life. Persistent pain after radiographic evidence of fracture union commonly leads to implant removal. But, the routine removal of orthopaedic fixation devices after fracture healing remains an issue of debate.
Detailed description
Many surgeons remember patients whose intractable, hardly explainable local symptoms and complaints of pain resolved quickly after a hardware-removal procedure. However, implant removal requires a second surgical procedure in scarred tissue, poses a risk for nerve damage, infection and re-fractures, and is not a guarantee of pain relief. Rates of implant removal vary based on anatomic location and implant selection. Many studies have introduced and assessed the outcomes of hardware removal in the ankle, tibia and femur. But, there is currently no controlled trial that assesses the benefits and harms of sacroiliac (SI) screw removal in pelvic fracture patients. Reports in literature are not consistent concerning the incidence of painful hardware and the outcome and pain relief after hardware removal. There is conflicting evidence that removing hardware decreases acute pain in ankle, tibia, and femur fractures but there is a need to explore the effect of SI screw removal in pelvic fracture patients. The investigators propose to prospectively randomize patients with a pelvic fracture requiring the use of SI screws for stabilization to removal versus non-removal of SI screws and track which group has less pain and need for narcotic pain medications.
Interventions
PROCEDURESI Screw Removal Surgery
PROCEDURENon-screw removal treatment (non-operative management)
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The patient is between 18 and 80 years of age, inclusive * The patient has a pelvic fracture that required SI screw stabilization * The patient has reached skeletal maturity * The patient's pelvic fracture was the result of trauma (includes polytraumatized patients) * The patient is English-speaking * The patient's pelvic fracture was initially treated at Shock Trauma * The patient is currently experiencing pain associated with his/her pelvic fracture * The patient's surgeon agrees to randomization (the patient is amendable to either SI screw removal or non-screw removal treatment) * The patient is able to be randomized between 4 and 8 months post-SI screw stabilization surgery at an orthopaedic follow-up appointment
Exclusion criteria
* The patient is non-ambulatory due to an associated spinal cord injury * The patient was non-ambulatory pre-injury * The patient is currently pregnant * The patient is enrolled in another study that does not allow co-enrollment * The patient is likely to have severe problems with maintaining follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Within 6 Months After Iliosacral Screw Removal Using the Brief Pain Inventory (BPI) | Up to 24 months post initial SI screw stabilization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Function Within 6 Months After Iliosacral Screw Removal, Measured Using the Majeed Pelvic Outcome Score. | Up to 24 months post initial SI screw stabilization | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| 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) | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Total | Non-screw Removal | Screw Removal |
|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 14.5 | 34 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 16 |
| Area Deprivation Index | 44.5 units on a scale STANDARD_DEVIATION 22.5 | 49 units on a scale STANDARD_DEVIATION 27 | 40 units on a scale STANDARD_DEVIATION 18 |
| fracture classification Anterior Posterior Compression 1 (APC1) | 1 Participants | 1 Participants | 0 Participants |
| fracture classification Anterior Posterior Compression 2 (APC 2) | 4 Participants | 3 Participants | 1 Participants |
| fracture classification Anterior Posterior Compression 3 (APC 3) | 4 Participants | 3 Participants | 1 Participants |
| fracture classification Lateral Compression 1 (LC 1) | 13 Participants | 4 Participants | 9 Participants |
| fracture classification Lateral Compression 2 (LC 2) | 4 Participants | 1 Participants | 3 Participants |
| fracture classification Lateral Compression 3 (LC 3) | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 7 Participants | 7 Participants |
| Region of Enrollment United States | 54 participants | 14 participants | 14 participants |
| Sex: Female, Male Female | 9 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 19 Participants | 11 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 1 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 1 / 14 | 1 / 14 |
Outcome results
Primary
Post-operative Pain Within 6 Months After Iliosacral Screw Removal Using the Brief Pain Inventory (BPI)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screw Removal | 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 |
| Non-screw Removal | Post-operative Pain Within 6 Months After Iliosacral Screw Removal Using the Brief Pain Inventory (BPI) | 4.7 units on a scale | Standard Deviation 3 |
Comparison: We reported the average pain and function from 6 to 24 months postinjury with 95% confidence intervals (CIs) and summarized pain and function at 6, 9, 12, 18, and 24 months postinjury with means and standard deviations and medians with interquartile ranges.p-value: =0.5795% CI: [-0.8, 1.4]t-test, 2 sided
Secondary
Pelvic Function Within 6 Months After Iliosacral Screw Removal, Measured Using the Majeed Pelvic Outcome Score.
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screw Removal | 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 |
| Non-screw Removal | Pelvic Function Within 6 Months After Iliosacral Screw Removal, Measured Using the Majeed Pelvic Outcome Score. | 63.6 score on a scale of 0-100 | Standard Deviation 23.6 |
p-value: 0.2195% CI: [-2.9, 12.3]t-test, 2 sided