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

NCT06409559 | Recruiting FDA Device

• 1 other identifier: OS22025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acetabular Fracture

Outcome Measures

Primary Outcomes (3)

• Displacement of posterior wall acetabular fragment

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

  12 months

• Healing of the posterior wall fragment

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

  12 months

• Articular space loss

  Degree and extent of articular space loss (chondrolysis)

  12 months

Secondary Outcomes (5)

• Modified Merle d'Aubigne score

  12 months

• IOWA hip score

  12 months

• PROMIS-10 score

  12 months

• SMFA score

  12 months

• SF 36 score

  12 months

Study Arms (2)

Rim plate group

OTHER

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

Device: Pelvic reconstruction plate without interfragmentary screws

Buttress plate group

OTHER

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

Device: Pelvic reconstruction plate with interfragmentary screws

Interventions

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.

Rim plate group

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.

Buttress plate group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (10)

• JUDET R, JUDET J, LETOURNEL E. FRACTURES OF THE ACETABULUM: CLASSIFICATION AND SURGICAL APPROACHES FOR OPEN REDUCTION. PRELIMINARY REPORT. J Bone Joint Surg Am. 1964 Dec;46:1615-46. No abstract available.

  PMID: 14239854 BACKGROUND

• Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.

  PMID: 8934477 BACKGROUND

• Moed BR, Kregor PJ, Reilly MC, Stover MD, Vrahas MS. Current management of posterior wall fractures of the acetabulum. Instr Course Lect. 2015;64:139-59.

  PMID: 25745901 BACKGROUND

• Pease F, Ward AJ, Stevenson AJ, Cunningham JL, Sabri O, Acharya M, Chesser T. Posterior wall acetabular fracture fixation: A mechanical analysis of fixation methods. J Orthop Surg (Hong Kong). 2019 Sep-Dec;27(3):2309499019859838. doi: 10.1177/2309499019859838.

  PMID: 31311424 BACKGROUND

• Baumgaertner MR. Fractures of the posterior wall of the acetabulum. J Am Acad Orthop Surg. 1999 Jan;7(1):54-65. doi: 10.5435/00124635-199901000-00006.

  PMID: 9916185 BACKGROUND

• D'AUBIGNE RM, POSTEL M. Functional results of hip arthroplasty with acrylic prosthesis. J Bone Joint Surg Am. 1954 Jun;36-A(3):451-75. No abstract available.

  PMID: 13163078 BACKGROUND

• Larson CB. Rating scale for hip disabilities. Clin Orthop Relat Res. 1963;31:85-93. No abstract available.

  PMID: 5888865 BACKGROUND

• Reeve BB, Hays RD, Bjorner JB, Cook KF, Crane PK, Teresi JA, Thissen D, Revicki DA, Weiss DJ, Hambleton RK, Liu H, Gershon R, Reise SP, Lai JS, Cella D; PROMIS Cooperative Group. Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Med Care. 2007 May;45(5 Suppl 1):S22-31. doi: 10.1097/01.mlr.0000250483.85507.04.

  PMID: 17443115 BACKGROUND

• Swiontkowski MF, Engelberg R, Martin DP, Agel J. Short musculoskeletal function assessment questionnaire: validity, reliability, and responsiveness. J Bone Joint Surg Am. 1999 Sep;81(9):1245-60. doi: 10.2106/00004623-199909000-00006.

  PMID: 10505521 BACKGROUND

• Laucis NC, Hays RD, Bhattacharyya T. Scoring the SF-36 in Orthopaedics: A Brief Guide. J Bone Joint Surg Am. 2015 Oct 7;97(19):1628-34. doi: 10.2106/JBJS.O.00030.

  PMID: 26446970 BACKGROUND

Central Study Contacts

Kimberly A Hasselfeld

CONTACT

5135581933; hasselky@uc.edu

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: Professor

Model Details: Parallel assignment to two different methods of screw and plate fixation of posterior wall acetabulum fractures.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: August 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)