Geriatric Lateral Compression 1 Pelvic Fractures

NCT05765669 | Recruiting

• 1 other identifier: A22-184
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Lateral compression-1 (LC1) pelvic ring fragility fractures cause significant pain and morbidity. These fragility injuries are associated with prolonged immobility and long hospital stays. Currently there is no consensus on operative stabilization of LC1 pelvic fractures, nor are there evidence-based guidelines to aid in management of these injury types. Furthermore, there is variability in operative indications, improvement in pain and mobilization. The purpose of this study is to compare percutaneous screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.

Conditions

Lateral Compression 1 Pelvic Fracture

Keywords

Lateral compression; Operative; Non-operative; Fragility fracture; Pelvic fracture; Percutaneous pelvis screw; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Timed Up and Go (TUG) assessment

  Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of physical therapy to get up from a chair, walk 3 meters turn around walk 3 meters back to the chair and sit down.

  Day 2 after treatment

Secondary Outcomes (7)

• Sacral Region Pain by Visual Analog Scale

  Day 2, 2 weeks, 6 weeks, and 3 months after treatment

• Timed Up and Go (TUG) assessment

  2 weeks, 6 weeks, and 3 months after treatment

• Discharge Disposition Location

  Post discharge from treatment, an average of 5 days from being admitted to the hospital

• Longest Distance of Ambulation

  Day 2 after treatment

• Use of Narcotic Pain Medication

  Day 2 after treatment

Study Arms (2)

Operative

EXPERIMENTAL

Percutaneous screw fixation

Procedure: Percutaneous screw fixation

Non-operative

EXPERIMENTAL

Pain management and physical therapy advanced with weight bearing as tolerated.

Other: Pain management; Other: Physical therapy

Interventions

Percutaneous screw fixation PROCEDURE

Surgical intervention in the form of percutaneous screw fixation

Operative

Pain management OTHER

Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated

Non-operative

Physical therapy OTHER

Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated

Non-operative

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>/= 60 years of age
• Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and/or MRI
• Low energy mechanism of injury or an insufficiency fracture without a precipitating event
• Acute injury within four weeks of presentation
• Inability or significant pain to mobilize with physical therapy assistance for 48 hours: Significant pain as determined by a pain score ≥ 7 with the Visual Analogue Scale (VAS) after a Timed "Up \& Go" (TUG) assessment, or inability to complete the TUG assessment.

You may not qualify if:

• Dementia
• Vertically or rotationally unstable pelvic ring injuries
• Pathologic fracture secondary to tumor
• Non-ambulatory prior to injury
• Acute neurologic deficit
• High-energy mechanism of injury
• Concomitant injuries affecting ambulation
• Presence of another injury or medical condition that prevents ambulation
• Presence of implant or sacral morphology that prevents percutaneous sacral fixation
• Enrollment in another research study the precludes co-enrollment
• Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.)
• Incarcerated or pending incarceration

Sponsors & Collaborators

• HealthPartners Institute: lead
• Orthopaedic Trauma Association: collaborator
• Allina Health System: collaborator

Study Sites (3)

Allina, Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Park Nicollet, Methodist Hospital

Saint Louis Park, Minnesota, 55426, United States

RECRUITING

HealthPartners, Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

Related Publications (15)

• Soles GL, Ferguson TA. Fragility fractures of the pelvis. Curr Rev Musculoskelet Med. 2012 Sep;5(3):222-8. doi: 10.1007/s12178-012-9128-9.

  PMID: 22589010 BACKGROUND

• Wright NC, Looker AC, Saag KG, Curtis JR, Delzell ES, Randall S, Dawson-Hughes B. The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res. 2014 Nov;29(11):2520-6. doi: 10.1002/jbmr.2269.

  PMID: 24771492 BACKGROUND

• Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007 Mar;22(3):465-75. doi: 10.1359/jbmr.061113.

  PMID: 17144789 BACKGROUND

• Clement ND, Court-Brown CM. Elderly pelvic fractures: the incidence is increasing and patient demographics can be used to predict the outcome. Eur J Orthop Surg Traumatol. 2014 Dec;24(8):1431-7. doi: 10.1007/s00590-014-1439-7. Epub 2014 Mar 25.

  PMID: 24664452 BACKGROUND

• Fisher ND, Solasz SJ, Tensae A, Konda SR, Egol KA. Low-energy lateral compression type 1 (LC1) pelvic ring fractures in the middle-aged and elderly affect hospital quality measures and functional outcomes. Eur J Orthop Surg Traumatol. 2022 Oct;32(7):1379-1384. doi: 10.1007/s00590-021-03125-7. Epub 2021 Sep 20.

  PMID: 34545463 BACKGROUND

• Mullis BH, Agel J, Jones C, Lowe J, Vallier H, Teague D, Kempton L, Schmidt A, Friess D, Morshed S, Miller AN, Leighton R, Tornetta P 3rd. Unilateral Sacral Fractures Demonstrate Slow Recovery of Patient-Reported Outcomes Irrespective of Treatment. J Orthop Trauma. 2022 Apr 1;36(4):179-183. doi: 10.1097/BOT.0000000000002260.

  PMID: 34483321 BACKGROUND

• Beckmann JT, Presson AP, Curtis SH, Haller JM, Stuart AR, Higgins TF, Kubiak EN. Operative agreement on lateral compression-1 pelvis fractures. a survey of 111 OTA members. J Orthop Trauma. 2014 Dec;28(12):681-5. doi: 10.1097/BOT.0000000000000133.

  PMID: 24786733 BACKGROUND

• Parry JA, Funk A, Heare A, Stacey S, Mauffrey C, Starr A, Crist B, Krettek C, Jones CB, Kleweno CP, Firoozabadi R, Sagi HC, Archdeacon M, Eastman J, Langford J, Oransky M, Martin M, Cole P, Giannoudis P, Byun SE, Morgan SJ, Smith W, Giordano V, Trikha V. An international survey of pelvic trauma surgeons on the management of pelvic ring injuries. Injury. 2021 Oct;52(10):2685-2692. doi: 10.1016/j.injury.2020.07.027. Epub 2020 Jul 11.

  PMID: 32943214 BACKGROUND

• Gaski GE, Manson TT, Castillo RC, Slobogean GP, O'Toole RV. Nonoperative treatment of intermediate severity lateral compression type 1 pelvic ring injuries with minimally displaced complete sacral fracture. J Orthop Trauma. 2014 Dec;28(12):674-80. doi: 10.1097/BOT.0000000000000130.

  PMID: 24740110 BACKGROUND

• Slobogean GP, Gaski GE, Nascone J, Sciadini MF, Natoli RM, Manson TT, Lebrun C, McKinley T, Virkus WW, Sorkin AT, Brown K, Howe A, Rudnicki J, Enobun B, O'Hara NN, Gill J, O'Toole RV. A Prospective Clinical Trial Comparing Surgical Fixation Versus Nonoperative Management of Minimally Displaced Complete Lateral Compression Pelvis Fractures. J Orthop Trauma. 2021 Nov 1;35(11):592-598. doi: 10.1097/BOT.0000000000002088.

  PMID: 33993178 BACKGROUND

• Tornetta P 3rd, Lowe JA, Agel J, Mullis BH, Jones CB, Teague D, Kempton L, Brown K, Friess D, Miller AN, Spitler CA, Kubiak E, Gary JL, Leighton R, Morshed S, Vallier HA. Does Operative Intervention Provide Early Pain Relief for Patients With Unilateral Sacral Fractures and Minimal or No Displacement? J Orthop Trauma. 2019 Dec;33(12):614-618. doi: 10.1097/BOT.0000000000001578.

  PMID: 31403559 BACKGROUND

• Walker JB, Mitchell SM, Karr SD, Lowe JA, Jones CB. Percutaneous Transiliac-Transsacral Screw Fixation of Sacral Fragility Fractures Improves Pain, Ambulation, and Rate of Disposition to Home. J Orthop Trauma. 2018 Sep;32(9):452-456. doi: 10.1097/BOT.0000000000001243.

  PMID: 29916895 BACKGROUND

• Hopf JC, Krieglstein CF, Muller LP, Koslowsky TC. Percutaneous iliosacral screw fixation after osteoporotic posterior ring fractures of the pelvis reduces pain significantly in elderly patients. Injury. 2015 Aug;46(8):1631-6. doi: 10.1016/j.injury.2015.04.036. Epub 2015 May 14.

  PMID: 26052052 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.

  PMID: 11856064 BACKGROUND

Related Links

• American Academy of Orthopaedic Surgeon clinical practice guidelines

MeSH Terms

Conditions

Hip Fractures; Osteoporosis

Interventions

Pain Management; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Disease Management; Patient Care Management; Health Services Administration; Rehabilitation

Study Officials

• Mai P. Nguyen, MD

  University of Minnesota and HealthPartners

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mai P Nguyen, MD

CONTACT

651-254-3669; mai.p.nguyen@healthpartners.com

Sandy Vang, BA

CONTACT

651-254-6961; sandy.x.vang@healthpartners.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 13, 2023
• Study Start: May 5, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)