Sacroiliac (SI) Screws: The Effect of SI Screw Removal on Patient-Reported Pain and Functional Outcomes

NCT02652611 | Completed Results DMC

• 1 other identifier: HP-00063838
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Joint; Pain; Pelvis

Keywords

Screw Removal vs. Non-screw removal; Complications; SI Screw Stabilization

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 months post initial SI screw stabilization

Secondary Outcomes (1)

• 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

Study Arms (2)

Screw Removal

EXPERIMENTAL

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.

Procedure: SI Screw Removal Surgery

Non-screw Removal

EXPERIMENTAL

Patients enrolled in the Non-SI screw removal treatment group will not undergo surgical intervention to for removal of their SI screws. 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 complications arise and/or the patient requires screw removal surgery, crossover will be allowed and recorded within study follow0up forms.

Procedure: Non-screw removal treatment (non-operative management)

Interventions

SI Screw Removal Surgery PROCEDURE

Screw Removal

Non-screw removal treatment (non-operative management) PROCEDURE

Non-screw Removal

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (12)

• Jacobsen S, Honnens de Lichtenberg M, Jensen CM, Torholm C. Removal of internal fixation--the effect on patients' complaints: a study of 66 cases of removal of internal fixation after malleolar fractures. Foot Ankle Int. 1994 Apr;15(4):170-1. doi: 10.1177/107110079401500402.

  PMID: 7951948 BACKGROUND

• Brown OL, Dirschl DR, Obremskey WT. Incidence of hardware-related pain and its effect on functional outcomes after open reduction and internal fixation of ankle fractures. J Orthop Trauma. 2001 May;15(4):271-4. doi: 10.1097/00005131-200105000-00006.

  PMID: 11371792 BACKGROUND

• Dodenhoff RM, Dainton JN, Hutchins PM. Proximal thigh pain after femoral nailing. Causes and treatment. J Bone Joint Surg Br. 1997 Sep;79(5):738-41. doi: 10.1302/0301-620x.79b5.7345.

  PMID: 9331026 BACKGROUND

• Keating JF, Orfaly R, O'Brien PJ. Knee pain after tibial nailing. J Orthop Trauma. 1997 Jan;11(1):10-3. doi: 10.1097/00005131-199701000-00004.

  PMID: 8990026 BACKGROUND

• Court-Brown CM, Gustilo T, Shaw AD. Knee pain after intramedullary tibial nailing: its incidence, etiology, and outcome. J Orthop Trauma. 1997 Feb-Mar;11(2):103-5. doi: 10.1097/00005131-199702000-00006.

  PMID: 9057144 BACKGROUND

• Busam ML, Esther RJ, Obremskey WT. Hardware removal: indications and expectations. J Am Acad Orthop Surg. 2006 Feb;14(2):113-20. doi: 10.5435/00124635-200602000-00006.

  PMID: 16467186 BACKGROUND

• Gerbershagen HJ, Dagtekin O, Isenberg J, Martens N, Ozgur E, Krep H, Sabatowski R, Petzke F. Chronic pain and disability after pelvic and acetabular fractures--assessment with the Mainz Pain Staging System. J Trauma. 2010 Jul;69(1):128-36. doi: 10.1097/TA.0b013e3181bbd703.

  PMID: 20093984 BACKGROUND

• Meyhoff CS, Thomsen CH, Rasmussen LS, Nielsen PR. High incidence of chronic pain following surgery for pelvic fracture. Clin J Pain. 2006 Feb;22(2):167-72. doi: 10.1097/01.ajp.0000174266.12831.a2.

  PMID: 16428951 BACKGROUND

• Pohlemann T, Tscherne H, Baumgartel F, Egbers HJ, Euler E, Maurer F, Fell M, Mayr E, Quirini WW, Schlickewei W, Weinberg A. [Pelvic fractures: epidemiology, therapy and long-term outcome. Overview of the multicenter study of the Pelvis Study Group]. Unfallchirurg. 1996 Mar;99(3):160-7. German.

  PMID: 8685720 BACKGROUND

• Hanson B, van der Werken C, Stengel D. Surgeons' beliefs and perceptions about removal of orthopaedic implants. BMC Musculoskelet Disord. 2008 May 24;9:73. doi: 10.1186/1471-2474-9-73.

  PMID: 18501014 BACKGROUND

• Toms AD, Morgan-Jones RL, Spencer-Jones R. Intramedullary femoral nailing: removing the nail improves subjective outcome. Injury. 2002 Apr;33(3):247-9. doi: 10.1016/s0020-1383(01)00145-0.

  PMID: 12084641 BACKGROUND

• Williams AA, Witten DM, Duester R, Chou LB. The benefits of implant removal from the foot and ankle. J Bone Joint Surg Am. 2012 Jul 18;94(14):1316-20. doi: 10.2106/JBJS.J.01756.

  PMID: 22810403 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Haley Demyanovich
• Organization: U Maryland

hdemyanovich@som.umaryland.edu

4107063935

Study Officials

• Marcus Sciadini, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Gerard Slobogean, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Orthopaedics

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 12, 2016
• Study Start: September 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)