Acetabular FractureNCT06409559
Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws
A study testing Pelvic reconstruction plate without interfragmentary screws and Pelvic reconstruction plate with interfragmentary screws in people with Acetabular Fracture, run by University of Cincinnati at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fracture
- What is being tested?
- Pelvic reconstruction plate without interfragmentary screws and Pelvic reconstruction plate with interfragmentary screws
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
Kim Hasselfeld, 5137776213, hasselky@uc.edu
Henry C Sagi, MD
About this study
Official title: A Randomized Prospective Study Comparing 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.
Read the detailed 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.
- Conditions
- Acetabular Fracture
- Being tested
- Pelvic reconstruction plate without interfragmentary screws, Pelvic reconstruction plate with interfragmentary screws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic reconstruction plate without interfragmentary screwsDevice
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 screwsDevice
The posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Pelvic reconstruction plate with interfragmentary screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement of posterior wall acetabular fragment
Measured on immediate post-op CT and compared to measurement one year post-op
Measured: 12 months
Healing of the posterior wall fragment
Measured on immediate post-op CT and compared to measurement one year post-op
Measured: 12 months
Articular space loss
Degree and extent of articular space loss (chondrolysis)
Measured: 12 months
Secondary outcomes (5)
Modified Merle d'Aubigne score
Evaluates pain, gait and mobility
Measured: 12 months
IOWA hip score
Hip rating system
Measured: 12 months
PROMIS-10 score
A system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being
Measured: 12 months
SMFA score
Measure the functional status of patients with a broad range of musculoskeletal injuries and disorders
Measured: 12 months
SF 36 score
Quantifies health status and measures health-related quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Aug 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acetabular FractureStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Parallel assignment to two different methods of screw and plate fixation of posterior wall acetabulum fractures.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Claude Sagi, MD, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409559
- Sponsor's protocol ID
- OS22025
- Status last verified
- Apr 2026
- First submitted
- 7 May 2024
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 14239854Matta 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.
PubMed 8934477Moed 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.
PubMed 25745901Pease 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.
PubMed 31311424Baumgaertner 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.
PubMed 9916185D'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.
PubMed 13163078Larson CB. Rating scale for hip disabilities. Clin Orthop Relat Res. 1963;31:85-93. No abstract available.
PubMed 5888865Reeve 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.
PubMed 17443115Swiontkowski 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.
PubMed 10505521Laucis 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.
PubMed 26446970
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Study Comparing Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws
- ClinicalTrials.gov ID
- NCT06409559
- Acronym / sponsor ID
- OS22025
- Conditions
- Acetabular Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment to two different methods of screw and plate fixation of posterior wall acetabulum fractures.
| Arm | Type | Receives |
|---|---|---|
| Rim plate group | Other | Device: Pelvic reconstruction plate without interfragmentary screwsThis 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. |
| Buttress plate group | Other | Device: Pelvic reconstruction plate with interfragmentary screwsThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic reconstruction plate without interfragmentary screwsThe posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate. | Device | Rim plate group |
| Pelvic reconstruction plate with interfragmentary screwsThe posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws. | Device | Buttress plate group |
Primary outcome
Displacement of posterior wall acetabular fragment
Time frame: 12 months
Measured on immediate post-op CT and compared to measurement one year post-op
Healing of the posterior wall fragment
Time frame: 12 months
Measured on immediate post-op CT and compared to measurement one year post-op
Articular space loss
Time frame: 12 months
Degree and extent of articular space loss (chondrolysis)
5 secondary outcomes
Modified Merle d'Aubigne score
Time frame: 12 months
IOWA hip score
Time frame: 12 months
PROMIS-10 score
Time frame: 12 months
SMFA score
Time frame: 12 months
SF 36 score
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 14239854JUDET 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.
- Background: PubMed 8934477Matta 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.
- Background: PubMed 25745901Moed 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.
- Background: PubMed 31311424Pease 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.
- Background: PubMed 9916185Baumgaertner 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.
- Background: PubMed 13163078D'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.
- Background: PubMed 5888865Larson CB. Rating scale for hip disabilities. Clin Orthop Relat Res. 1963;31:85-93. No abstract available.
- Background: PubMed 17443115Reeve 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.
- Background: PubMed 10505521Swiontkowski 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.
- Background: PubMed 26446970Laucis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic reconstruction plate without interfragmentary screws and Pelvic reconstruction plate with interfragmentary screws in people with Acetabular Fracture, run by University of Cincinnati at 1 site 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly A Hasselfeld (5135581933, hasselky@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Displacement of posterior wall acetabular fragment (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT06409559, which also lists 10 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 4 May 2026.