Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures

NCT06634290 | Recruiting FDA Device

• 1 other identifier: 2024-235
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of this clinical trial is to learn if small modifications in the surgical technique for the treatment of some kind of hip fractures, improve the result of the surgery. This small modification includes the addition of surgical bone cement to part of the intramedullary nail used in the surgery, to find out if it provides more stability to the construct and represents an improvement in the surgery result. The main question it aims to answer is: Does the addition of bone cement produces a decrease in complications related to mechanical failure of the implant used in the surgery and a decrease in the need for re-operation? Researchers will compare adding this bone cement to the standard surgical technique without it. Patients will:

• Be randomly assigned to a group that will have surgery following standard protocol or to a group that will have surgery following standard protocol but adding bone cement to the construct.
• Receive standard care for these fractures during hospitalization and posterior follow-up checkups for a year.

Conditions

Hip Fracture of Intertrochanteric Type

Keywords

hip fracture; osteosynthesis; intramedullary nailing; bone cement augmentation

Outcome Measures

Primary Outcomes (1)

• Mechanical failure rate of the implant

  Defined as the intolerable loss of reduction of the fracture and the failure of osteosynthesis due to breakage or disassembly of the implant used, which requires surgical reintervention.

  From date of surgery until the date of mechanical failure diagnosis, assessed up to 52 weeks

Secondary Outcomes (3)

• Perioperative mortality rate

  From date of surgery until the date of hospital discharge, assessed up to a maximum of 7 days

• One-month mortality rate

  From date of surgery up to 30 days

• One-year mortality rate

  From date of surgery up to 52 weeks

Study Arms (2)

Cemented

EXPERIMENTAL

Patients diagnosed of pertrochanteric hip fracture treated with intramedullary nailing WITH cephalic augmentation using bone cement

Device: intramedullary nailing augmentation

Not Cemented

ACTIVE COMPARATOR

Patients diagnosed of pertrochanteric hip fracture treated with intramedullary nailing WITHOUT cephalic augmentation

Device: intramedullary nailing

Interventions

intramedullary nailing augmentation DEVICE

Treatment of pertrochanteric hip fractures with intramedullary nailing with cephalic augmentation with bone cement

Also known as: Osteosynthesis

Cemented

intramedullary nailing DEVICE

Treatment of pertrochanteric hip fractures with intramedullary nailing without cephalic augmentation

Also known as: osteosynthesis

Not Cemented

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older.
• Diagnosis with a pertrochanteric fragility fracture.
• Informed consent for participation in the study.

You may not qualify if:

• Refusal of the patient or his/her legal representative to participate in the study.
• Diagnosis with hip fracture of subtypes other than 31A1, 31A2, 31A3 and 31B3 of AO-OTA classification.
• Bilateral hip fractures in the same episode.
• Suffering from previous medical pathologies or comorbidities that contraindicate surgical intervention and indicate conservative management of the fracture.
• Performing a surgical technique different from intramedullary nailing or using a surgical implant different from that used in the present study.

Sponsors & Collaborators

• Diego Matías Domínguez Prado: lead

Study Sites (6)

Hospital de Monforte de Lemos

Monforte de Lemos, Lugo, 27400, Spain

RECRUITING

Hospital de Verin

Verín, Ourense, 32600, Spain

RECRUITING

Complexo Hospitalario Universitario de Vigo

Vigo, Pontevedra, 36312, Spain

RECRUITING

Hospital do Salnes

Vilagarcía de Arousa, Pontevedra, 36619, Spain

RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, 32005, Spain

RECRUITING

Complexo Hospitalario Pontevedra

Pontevedra, 36071, Spain

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

Fracture Fixation, Internal; Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Diego Matias Dominguez Prado, MD, PhD

  Complexo Hospitalario de Ourense

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Matias Dominguez Prado, MD, PhD

CONTACT

34+ 670462170; diego.matias.dominguez.prado@sergas.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist in Orthopedic Surgery and Traumatology, PhD

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: October 9, 2024
• Study Start: September 30, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 3 months after publication of results
• Access Criteria: Researchers who wish to access data for meta-analysis. Data sharing must be approved by principal research who can be contacted by e-mail.

Locations

ES (6)