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

Acetabular Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06409559
• Other study ID #: OS22025
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: University of Cincinnati
• Contact: Kimberly A Hasselfeld
• Phone: 5135581933
• Email: hasselky[@]uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Skeletally mature males and females, = 18 years old and with age less than 65 years.

2. Fracture of the acetabular posterior wall fracture due to acute traumatic hip dislocation, confirmed with anteroposterior pelvic or hip radiographs, and CT scan

3. Operative fixation of fractures within 14 days of presenting to the emergency room.

4. Patient was ambulatory prior to fracture, with or without walking aids

5. Medically optimized for operative intervention

6. Provision of informed consent by patient or legal guardian.

Exclusion Criteria:

1. Patients not suitable for internal fixation (severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).

2. Pre-existing orthopedic fixation, implant, or prosthesis around the affected acetabulum.

3. Patients with metabolic bone disease including diagnosis of osteoporosis.

4. Patients with bony or soft tissue infections around the acetabulum.

5. Patients unable to provide informed consent.

6. Patients having other fractures of Pelvis or acetabulum other than an isolated posterior acetabular wall fracture.

7. Patients with previous history of acetabular fracture (operative or nonoperative)

8. Patients with previous history of hip pathology such as avascular necrosis, hip dysplasia, Legg-Calve Perthes Disease, or advanced degenerative arthritis.

Related Conditions & MeSH terms

• Acetabular Fracture
• Fractures, Bone

Intervention

Procedure:
• pelvic reconstruction
interfragmentary screws placed through the plate or buttress plate applied under compression without interfragmentary lag or position screws

Locations

Country	Name	City	State
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Displacement of posterior wall acetabular fragment	Measured on immediate post-op CT and compared to measurement one year post-op	12 months
Primary	Healing of the posterior wall fragment	Measured on immediate post-op CT and compared to measurement one year post-op	12 months
Primary	Articular space loss	Degree and extent of articular space loss (chondrolysis)	12 months
Secondary	Modified Merle d'Aubigne score	Evaluates pain, gait and mobility	12 months
Secondary	IOWA hip score	Hip rating system	12 months
Secondary	PROMIS-10 score	A system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being	12 months
Secondary	SMFA score	Measure the functional status of patients with a broad range of musculoskeletal injuries and disorders	12 months
Secondary	SF 36 score	Quantifies health status and measures health-related quality of life	12 months