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NCT Number: NCT06409559

Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws

The hypothesis of this study is that the Rim Plate method utilizing interfragmentary screws placed through the plate will result in superior fixation, a lower rate of loss of reduction of the fracture fragment, better anatomic healing of the articular (joint) surface, a decreased rate of early post-traumatic arthritic changes of the joint (cartilage) surface, and improved functional outcomes.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location status: Recruiting

Location contact

Henry C Sagi, MD

PRINCIPAL_INVESTIGATOR

Kim Hasselfeld

CONTACT

[email protected]

5137776213

About this study

Study type: Interventional Estimated enrollment: 60 Allocation: block randomization. The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time.

Interventional model: parallel assignment Description: two different methods of screw and plate fixation of posterior wall acetabulum fractures.

Time perspective: Prospective

Population:

Skeletally mature patients who have presented with an acute traumatic fracture of the posterior wall of acetabulum due to dislocation of the femoral head will be included in this study. All surgeons on the study routinely perform both types of repairs.

Treatment arms and Intervention:

Arm A: Rim plate group - This group will consist of 30 patients where the posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate.

Arm B: Buttress plate group - This group will consist of 30 patients where the posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Skeletally mature males and females, ≥ 18 years old and with age less than 65 years.
  • Fracture of the acetabular posterior wall fracture due to acute traumatic hip dislocation, confirmed with anteroposterior pelvic or hip radiographs, and CT scan
  • Operative fixation of fractures within 14 days of presenting to the emergency room.
  • Patient was ambulatory prior to fracture, with or without walking aids
  • Medically optimized for operative intervention
  • Provision of informed consent by patient or legal guardian.

Exclusion criteria

  • Patients not suitable for internal fixation (severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
  • Pre-existing orthopedic fixation, implant, or prosthesis around the affected acetabulum.
  • Patients with metabolic bone disease including diagnosis of osteoporosis.
  • Patients with bony or soft tissue infections around the acetabulum.
  • Patients unable to provide informed consent.
  • Patients having other fractures of Pelvis or acetabulum other than an isolated posterior acetabular wall fracture.
  • Patients with previous history of acetabular fracture (operative or nonoperative)
  • Patients with previous history of hip pathology such as avascular necrosis, hip dysplasia, Legg-Calve Perthes Disease, or advanced degenerative arthritis.

Treatment and study plan

Pelvic reconstruction plate without interfragmentary screws

Device

The posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate.

Pelvic reconstruction plate with interfragmentary screws

Device

The posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.

Primary outcomes

  1. Displacement of posterior wall acetabular fragment

    Time frame: 12 months

    Measured on immediate post-op CT and compared to measurement one year post-op

  2. Healing of the posterior wall fragment

    Time frame: 12 months

    Measured on immediate post-op CT and compared to measurement one year post-op

  3. Articular space loss

    Time frame: 12 months

    Degree and extent of articular space loss (chondrolysis)

Secondary outcomes

  1. Modified Merle d'Aubigne score

    Time frame: 12 months

    Evaluates pain, gait and mobility

  2. IOWA hip score

    Time frame: 12 months

    Hip rating system

  3. PROMIS-10 score

    Time frame: 12 months

    A system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being

  4. SMFA score

    Time frame: 12 months

    Measure the functional status of patients with a broad range of musculoskeletal injuries and disorders

  5. SF 36 score

    Time frame: 12 months

    Quantifies health status and measures health-related quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly A Hasselfeld

CONTACT

[email protected]

5135581933

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

A Randomized Prospective Study Comparing Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 10, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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