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Lateral Compression 1 Pelvic FractureNCT05765669

Geriatric Lateral Compression 1 Pelvic Fractures

A study testing Percutaneous screw fixation, Pain management and Physical therapy in people with Lateral Compression 1 Pelvic Fracture, run by HealthPartners Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 100 years
Conditions the study is for
Lateral Compression 1 Pelvic Fracture
What is being tested?
Percutaneous screw fixation, Pain management and Physical therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesUnited States
Study dates
5 May 2023to 18 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Allina, Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Park Nicollet, Methodist Hospital

    Saint Louis Park, Minnesota, 55426

  • HealthPartners, Regions Hospital

    Saint Paul, Minnesota, 55101

Other trials in United States

About this study

Official title: Percutaneous Screw Fixation for Operative Treatment Versus Non-Operative Treatment of Geriatric Lateral Compression 1 Pelvic Fractures - A Randomized Controlled Trial

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.

Read the detailed description

This study is a prospective, randomized control trial (RCT) of 100 patients with fragility pelvic ring fractures. All patients presenting with pelvic ring fractures classified as LC1 confirmed with plain radiographs, CT and/or MRI, resulting from a low energy mechanism or an insufficiency fracture without a precipitating event will undergo a trial of physical therapy with mobilization and multimodal pain management. If the subject has substantial posterior pelvic pain (score ≥ 7 with the Visual Analogue Scale (VAS)) or inability to ambulate after the physical therapy trial for 48 hours, the subject is eligible for enrollment in the RCT. Patients will either be grouped into an operative group, defined as percutaneous screw fixation, or a nonoperative group, defined as treatment with physical therapy and pain management only.

  1. Group 1-Operative treatment: Percutaneous screw fixation will be performed for stabilization of the pelvic fracture
  2. Group 2-Conservative (non-operative) treatment: Pain management and physical therapy advanced with weight bearing as tolerated.
Being tested
Percutaneous screw fixation, Pain management, Physical therapy
Keywords
Lateral compression, Operative, Non-operative, Fragility fracture, Pelvic fracture, Percutaneous pelvis screw, Osteoporosis
Medical subject headings
Hip Fractures, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous screw fixationProcedure or surgery

    Surgical intervention in the form of percutaneous screw fixation

  • Pain managementOther

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

  • Physical therapyOther

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

Study groups in NCT05765669
Study groupRoleWhat they receive
OperativeExperimentalPercutaneous screw fixation
Receives: Procedure: Percutaneous screw fixation
Non-operativeExperimentalPain management and physical therapy advanced with weight bearing as tolerated.
Receives: Other: Pain management; Other: Physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 2 after treatment

Secondary outcomes (7)
  1. Sacral Region Pain by Visual Analog Scale

    Patient reported pain on a scale of 0-10. Minimum score 0 (no pain) to maximum score 10 (worst possible pain)

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

  2. 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.

    Measured: 2 weeks, 6 weeks, and 3 months after treatment

  3. Discharge Disposition Location

    Where a patient went after being discharged from the hospital (home, rehabilitation center, skilled nursing facility)

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

  4. Longest Distance of Ambulation

    How far a patient was able to walk

    Measured: Day 2 after treatment

  5. Use of Narcotic Pain Medication

    Use of narcotic pain medication, total in milligram equivalents (MME)

    Measured: Day 2 after treatment

  6. Hospital Length of Stay

    Number of days admitted to hospital during treatment

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

  7. Rate of Complications

    Unplanned surgery, new neurological deficit after treatment, surgical site infection, re-admission, decubitus ulcer, pneumonia, deep vein thrombosis, pulmonary embolism, delirium, myocardial infarction, 90 days mortality

    Measured: 2 weeks, 6 weeks, and 3 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start5 May 2023
  3. Primary completion6 Aug 2025
  4. Study completion18 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05765669
Sponsor's protocol ID
A22-184
Status last verified
Jul 2026
First submitted
22 Feb 2023
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22589010
  • 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.

    PubMed 24771492
  • 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.

    PubMed 17144789
  • 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.

    PubMed 24664452
  • 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.

    PubMed 34545463
  • 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.

    PubMed 34483321
  • 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.

    PubMed 24786733
  • 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.

    PubMed 32943214
  • 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.

    PubMed 24740110
  • 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.

    PubMed 33993178
  • 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.

    PubMed 31403559
  • 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.

    PubMed 29916895
  • 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.

    PubMed 26052052
  • 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.

    PubMed 1991946
  • 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.

    PubMed 11856064

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous screw fixation, Pain management and Physical therapy in people with Lateral Compression 1 Pelvic Fracture, run by HealthPartners Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed Up and Go (TUG) assessment (time frame: Day 2 after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05765669, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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