Pelvic Reconstruction for Acetabular Fractures

Overseen By Kimberly A Hasselfeld

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Osteoarthritis, Rheumatoid arthritis, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-op period

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Pelvic Reconstruction for Acetabular Fractures?

Research shows that using reconstruction plates and buttress plates for acetabular fractures can be effective, with 85% of patients experiencing good results. These plates help stabilize the fracture and maintain the correct position of the bone, which is crucial for healing. ^{1 2 3 4 5}

Is pelvic reconstruction for acetabular fractures safe for humans?

In a study of 13 patients with acetabular fractures, 85% had good results using buttress plates, though 15% needed further surgery due to early arthritis. This suggests the procedure is generally safe, but some patients may experience complications. ^{1 4 6 7 8}

How is the treatment Pelvic Reconstruction for Acetabular Fractures different from other treatments?

Pelvic Reconstruction for Acetabular Fractures is unique because it uses specialized plates, such as buttress plates, to stabilize the fracture and maintain the structure of the pelvis, especially in complex cases with bone loss or displacement. This approach is particularly beneficial in older patients with osteoporotic bones, where maintaining the integrity of the pelvic structure is crucial. ^{1 2 4 6 9}

Eligibility Criteria

This trial is for individuals with a specific type of broken bone called an acetabular fracture, which affects the socket of the hip joint. Participants should not have other conditions that might interfere with the study or their ability to follow its procedures.

Inclusion Criteria

Provision of informed consent by patient or legal guardian

I am between 18 and 65 years old and my bones have stopped growing.

I have a broken hip bone from a recent injury, confirmed by X-rays and a CT scan.

Exclusion Criteria

I cannot have surgery due to severe joint issues or a certain type of fracture.

I have a metal implant near my hip joint.

I have been diagnosed with a bone condition, such as osteoporosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical fixation of posterior wall acetabular fractures using either a rim plate or buttress plate method

Immediate post-op period

Follow-up

Participants are monitored for displacement of the posterior wall acetabular fragment, healing, and functional outcomes

12 months

Treatment Details

Interventions

• Pelvic Reconstruction

Trial Overview The study is testing two methods of pelvic reconstruction in patients with acetabular fractures: Rim Plate and Buttress Plate, both potentially using inter-fragmentary screws. The goal is to see which method provides better stability, healing, and functional outcomes.

Participant Groups

Group I: Rim plate group Experimental Treatment 1 Intervention

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.

Group II: Buttress plate group Experimental Treatment 1 Intervention

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.

Pelvic Reconstruction is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Pelvic Reconstruction Plates for:

• Posterior wall acetabular fractures
• Complex pelvic fractures

Approved in United States as Acetabular Reconstruction Plates for:

• Acetabular fractures
• Pelvic ring injuries

Approved in Canada as Buttress Plates for:

• Posterior wall acetabular fractures
• Transverse acetabular fractures

Approved in Japan as Pelvic Reconstruction Plates for:

• Complex pelvic fractures
• Acetabular fractures

Approved in China as Acetabular Reconstruction Plates for:

• Posterior wall acetabular fractures
• Pelvic ring injuries

Approved in Switzerland as Buttress Plates for:

• Acetabular fractures
• Transverse acetabular fractures

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Findings from Research

Surgical treatment using reconstruction plates for old pelvic fractures in 24 patients resulted in satisfactory outcomes, with an average Majeed score of 84.4, indicating good functional recovery.

The study highlights the importance of accurate preoperative evaluation and proper reduction and fixation techniques, as 18 patients followed up showed 9 excellent and 5 good results over an average follow-up period of 24 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Operative treatment of old pelvic fractures: a report of 24 cases]. Wang, YS., Xu, YQ., Wei, LP., et al.[2012]

In a study of 45 patients with acetabular posterior wall fractures treated with reconstruction plate internal fixation, 88.9% achieved excellent or good clinical results, indicating the efficacy of this surgical approach.

No infections or non-unions were reported, suggesting a safe procedure; however, some complications like traumatic osteoarthritis and deep venous thromboembolism were noted, highlighting the need for careful postoperative monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment of acetabular posterior wall fractures]. Chen, HW., Zhao, GS.[2022]

Using a W-shaped acetabular angular plate (WAAP) for reconstructing posterior wall fractures significantly reduced the risk of intra-articular screw placement compared to traditional pelvic reconstruction plates, with a notable difference in screw placement accuracy (p = 0.002).

Despite the improved screw placement safety with WAAP, the overall quality of fracture reduction and clinical outcomes were similar to those achieved with reconstruction plates, indicating that WAAP provides stable fixation without compromising effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of W-shaped angular plate and reconstruction plate in treating posterior wall fractures of the acetabulum. Zhang, Q., Chen, W., Wu, X., et al.[2021]

In a retrospective study of 13 geriatric patients with acetabular fractures, the use of buttress plates via the ilio-inguinal approach resulted in 85% of patients achieving good outcomes after an average follow-up of 31 months.

Despite the overall success, 15% of patients developed early post-traumatic osteoarthritis, leading to the need for total hip arthroplasty within 18 months, highlighting the importance of monitoring for long-term complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open reduction and internal fixation of osteoporotic acetabular fractures through the ilio-inguinal approach: use of buttress plates to control medial displacement of the quadrilateral surface. Peter, RE.[2022]

In a study of 39 patients with complicated acetabular fractures, using a reconstruction belt resulted in significantly less plate shaping, shorter operation time, and reduced bleeding compared to using a reconstruction plate.

Both methods showed similar effectiveness in terms of pain relief and hip function after surgery, with no significant differences in fracture healing time or displacement between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[EFFICACY COMPARISON OF RECONSTRUCTION BELT AND RECONSTRUCTION PLATE FOR COMPLICATED ACETABULAR FRACTURE BY COMBINED ANTERIOR AND POSTERIOR APPROACHES]. Chen, L., Zhang, W., Shi, K., et al.[2019]

The study tested four different fixation methods for posterior column acetabular fractures using 20 cadaveric pelvises, revealing that the W-shaped acetabular angular plate provided the best stability, with stiffness values comparable to double reconstruction plates.

The W-shaped plate not only offered superior mechanical stability but also restored strain distribution around the acetabulum closer to that of an intact pelvis, indicating its potential for better functional outcomes in fracture stabilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior column acetabular fracture fixation using a W-shaped angular plate: A biomechanical analysis. Su, K., Liu, S., Wu, T., et al.[2022]

The study involved 16 acetabular specimens from 8 adult cadavers, comparing the biomechanical stability of a locked reconstruction plate versus a traditional fixation method for acetabular fractures.

Results indicated that while the locked reconstruction plate provided sufficient biomechanical stability, it showed slightly greater quadrilateral body displacement compared to the control group, suggesting it may reduce the risk of screw placement affecting the acetabular joints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[BIOMECHANICAL STUDY ON LOCKED RECONSTRUCTION PLATE FOR INTERNAL FIXATION OF TRANSVERSE AND POSTERIOR WALL ACETABULAR FRACTURE]. Ma, A., Pei, B., Pang, Z., et al.[2019]

The use of lateral wall stainless steel (LWSS) calcaneal plates for fixing posterior pelvic ring injuries and iliac blade fractures resulted in an average bony union time of 18 weeks, indicating effective healing in patients over a follow-up period of 18 months.

No instances of screw breakage or implant failure were reported, suggesting that LWSS plates are a safe and reliable option for surgical fixation in these complex injuries, making them a cost-effective choice for resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of calcaneal plates in the treatment of posterior pelvic ring injuries and displaced iliac blade fractures- A case series. Hussain, Z., Parmeshwar, SS., Jain, A., et al.[2023]

The study highlights the use of acetabular reinforcement devices as effective load-sharing solutions in cases of severe bone loss during hip reconstruction, particularly in complex scenarios like pelvic discontinuity.

Biomechanical analysis demonstrated that reinforced plates in the anterior column can enhance the stability of hip prostheses, as illustrated by a clinical case, suggesting improved outcomes for patients with significant acetabular defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical study of pelvic discontinuity in failed total hip arthroplasty. Lessons learnt from the treatment of pelvic fractures. Ribes-Iborra, J., Atienza, C., Sevil-De la Torre, J., et al.[2018]

References

1. China pubmed.ncbi.nlm.nih.gov

[Operative treatment of old pelvic fractures: a report of 24 cases]. [2012]

2. China pubmed.ncbi.nlm.nih.gov

[Surgical treatment of acetabular posterior wall fractures]. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparative study of W-shaped angular plate and reconstruction plate in treating posterior wall fractures of the acetabulum. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Open reduction and internal fixation of osteoporotic acetabular fractures through the ilio-inguinal approach: use of buttress plates to control medial displacement of the quadrilateral surface. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[EFFICACY COMPARISON OF RECONSTRUCTION BELT AND RECONSTRUCTION PLATE FOR COMPLICATED ACETABULAR FRACTURE BY COMBINED ANTERIOR AND POSTERIOR APPROACHES]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Posterior column acetabular fracture fixation using a W-shaped angular plate: A biomechanical analysis. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[BIOMECHANICAL STUDY ON LOCKED RECONSTRUCTION PLATE FOR INTERNAL FIXATION OF TRANSVERSE AND POSTERIOR WALL ACETABULAR FRACTURE]. [2019]

8. India pubmed.ncbi.nlm.nih.gov

Use of calcaneal plates in the treatment of posterior pelvic ring injuries and displaced iliac blade fractures- A case series. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Biomechanical study of pelvic discontinuity in failed total hip arthroplasty. Lessons learnt from the treatment of pelvic fractures. [2018]