Direct Anterior Approach Versus Mini Posterior Approach Versous Lateral Approach for Displaced Femoral Neck Fractures

NCT04618549 | Unknown

• 1 other identifier: 5
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

In general, hip fractures in the elderly are associated with a high one year-mortality up to 36 %. Apart from choosing the proper treatment, optimizing the surgical technique itself offers options to improve the outcome. Early mobilization after hip hemi¬arthroplasty correlates with improved ambulation, reduced need for assisted transfers, and less use of extended care facilities after hospital discharge. Nowadays, in order to reduce soft tissue damage and gain quicker postoperative recovery and faster rehabilitation, various MIS techniques have been proposed. Two of these techniques are the mini posterior approach and the mini direct anterior approach. The direct anterior approach was developed as a true internervous and intermuscular surgical approach with proposed benefits of faster recovery, quicker return to function, and less pain. In theory, the direct anterior approach should cause less tissue damage than mini posterior approach, as it is performed through a plane between neurlogical tissue and intermuscular plane without muscle transection. The aim of this study is to evaluate the clinical and radiological outcomes of the direct anterior approach for bipolar head endoprosthetic hemiarthroplasty in patients with displaced femoral neck fractures in comparison with the mini posterior approach and the traditional lateral approach, for the treatment of the same fractures. The investigators hypothesized that patients undergoing the direct anterior approach would have better clinical and radiological results in comparison with the mini posterior and lateral approach.

Conditions

Hip Fractures; Femoral Neck Fractures

Keywords

hip; fractures; surgical approach; outcome; bleeding

Outcome Measures

Primary Outcomes (6)

• The Five Item Barthel Index

  Patient mobilization and motoric status measured with a five-item-Barthel index. The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. The Barthel Index is a widely used measure of physical dependence in personal activities of daily living (PADL). The short five-item Barthel index score ranges from 0-15 points, with 0 means the worst score and 15 the optimal score that a patient can achieve.

  6 weeks post-surgery

• The Five Item Barthel Index

  Patient mobilization and motoric status measured with a five-item-Barthel index. The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. The Barthel Index is a widely used measure of physical dependence in personal activities of daily living (PADL). The short five-item Barthel index score ranges from 0-15 points, with 0 means the worst score and 15 the optimal score that a patient can achieve.

  3 months post-surgery

• The Timed Up and Go test (TUG)

  The Timed Up and Go test, is a test of balance that is commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down. Time taken to complete the test is strongly correlated to the level of functional mobility. Older adults who are able to complete the task in less than 20 seconds have been shown to be independent in transfer tasks involved in activities of daily living, and walk at gait speeds that should be sufficient for community mobility (0.5 m/s). In contrast, older adults requiring 30 seconds or longer to complete the task tend to be more dependent on activities of daily living and require assistive devices for ambulation.

  4 days after the surgery

• The Timed Up and Go test (TUG)

  The Timed Up and Go test, is a test of balance that is commonly used to examine functional mobility in community-dwelling, frail older adults. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down. Time taken to complete the test is strongly correlated to the level of functional mobility. Older adults who are able to complete the task in less than 20 seconds have been shown to be independent in transfer tasks involved in activities of daily living, and walk at gait speeds that should be sufficient for community mobility (0.5 m/s). In contrast, older adults requiring 30 seconds or longer to complete the task tend to be more dependent on activities of daily living and require assistive devices for ambulation.

  6 weeks post surgery

• Parker mobility score

  Postoperative mobility score, as proposed by Parker and Palmer (Parker MJ, Palmer CR, JBJS Br (1993) ). The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors and during shopping, and is used in studies either to measure the mobility as an outcome measure or as a predictor for mortality Range 0-9 points (0 is the worst score and 9 the best score that a patient can achieve)

  One week before the fracture occur

• Parker mobility score

  Postoperative mobility score, as proposed by Parker and Palmer (Parker MJ, Palmer CR, JBJS Br (1993) ). The Parker Mobility Score is a composite measurement of the patient's mobility indoors, outdoors and during shopping, and is used in studies either to measure the mobility as an outcome measure or as a predictor for mortality Range 0-9 points (0 is the worst score and 9 the best score that a patient can achieve)

  3 months post surgery

Secondary Outcomes (5)

• Change to the Total blood loss (TBL)

  Preop to day 4 post surgery

• Change at the Pain Visual Analog (VAS) score

  From day one up to 6 weeks post surgery

• Muscle Damage Markers

  Daily for days 1-4 Post-op

• Change at Creatine Kinase (CK)

  Daily for days 1-4 Post-op and at 6 weeks post-op

• Change at C-Reactive protein (CRP)

  Daily for days 1-4 Post-op and at 6 weeks post-op

Study Arms (3)

Direct anterior approach

ACTIVE COMPARATOR

Patients with a femoral neck fracture, treated by hemiarthroplasty by direct anterior approach, using a regular OR table, without hip hyperextension.

Procedure: Direct Anterior Approach Hemiarthroplasty

Mini Posterior Approach

ACTIVE COMPARATOR

Patients with a femoral neck fracture, treated by hemiarthroplasty by a mini posterior approach.

Procedure: Mini Posterior Approach

Lateral approach

ACTIVE COMPARATOR

Patients with a femoral neck fracture, treated by hemiarthroplasty by a lateral (Hardinge) approach.

Procedure: Lateral approach

Interventions

Direct Anterior Approach Hemiarthroplasty PROCEDURE

Hemiarthroplasty to elderly patients with femoral neck fracture through a direct anterior approach

Direct anterior approach

Mini Posterior Approach PROCEDURE

Hemiarthroplasty to elderly patients with femoral neck fracture through a mini posterior approach

Mini Posterior Approach

Lateral approach PROCEDURE

Hemiarthroplasty to elderly patients with femoral neck fracture through a lateral approach (Hardinge)

Lateral approach

Eligibility Criteria

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

You may qualify if:

• Consecutive patients undergoing hip fracture surgery for displaced femoral neck fractures (Garden 3 and 4 fractures) and treated by cemented hemiarthroplasty will be included in the study. Patients must have the ability to give informed consent or a legal guardian is available.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

MeSH Terms

Conditions

Hip Fractures; Femoral Neck Fractures; Fractures, Bone; Hemorrhage

Condition Hierarchy (Ancestors)

Femoral Fractures; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vasileios S Nikolaou, MD, PhD, MSc

CONTACT

+306932543400; vassilios.nikolaou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedics

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: November 6, 2020
• Study Start: November 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: March 30, 2022
• Last Updated: November 6, 2020

Record last verified: 2020-10