Assessing the Perioperative Outcomes of Minimally Invasive Posterior Approach Versus Direct Anterior Approach Total Hip Arthroplasty.

NCT06659198 | Completed DMC

• 1 other identifier: PTACONF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to compare the early post-operative outcomes of minimally invasive posterolateral approach (Mis-PLA) Vs. direct anterior approach (DAA) in the treatment of primary hip osteoarthritis, with regards to blood loss and postoperative pain. Fifty patients treated with THA from 2022 to 2023 are randomly assigned to either receive Mis-PLA or DAA THA. Visual Analog Scale (VAS) is used to assess pain and recorder ad hospital admission and on postoperative days 1 and 3. Intraoperative and postoperative blood loss and blood transfusion rate are recorded, as well as operation time and length of stay (LOS).

Conditions

Total Hip Replacement Surgery

Keywords

total hip replacement; minimally invasive posterolateral approach; direct anterior approach; blood management

Outcome Measures

Primary Outcomes (1)

• Number of participants requiring blood tranfusions

  Number (percentage) of participants requiring blood tranfusions

  preop to 3 days postop

Secondary Outcomes (1)

• Visual analog scale (VAS) score for each patient

  preop to 3 days postop

Other Outcomes (1)

• Number and type of intra- and post-operative complications

  Up to 30 days after surgery

Study Arms (2)

minimally invasive posterior approach

EXPERIMENTAL

minimally invasive posterior approach total hip replacement

Procedure: total hip replacement

direct anterior approach

EXPERIMENTAL

direct anterior approach total hip replacement

Procedure: total hip replacement

Interventions

total hip replacement PROCEDURE

minimally-invasive hip replacement

direct anterior approach; minimally invasive posterior approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical and instrumented diagnosis of unilateral primary or secondary end-stage hip osteoarthritis candidate to total hip arthroplasty
• patients with body mass index\<30 kg/m2,
• absence of liver disease, coagulative pathology

You may not qualify if:

• patients with history of bleeding or thrombotic disorder,
• patients with history of liver or renal disease
• patients with anticoagulant or antiplatelet therapy
• refusal to participate in the study

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead
• Istituto Clinico San Siro: collaborator

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 26, 2024
• Study Start: April 28, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

IT (1)