Investigating the Direct Superior Approach for Total Hip Arthroplasty as an Effective Alternative to Traditional Posterior Approach

NCT03227549 | Active Not Recruiting

• 1 other identifier: THA DSA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Hip replacement surgery is an effective option for treating pain and functional impairment in chronic hip conditions. Various surgical approaches have been developed to expose the hip joint for the procedure, each with advantages and disadvantages. The posterior approach (PA) to total hip replacement is a commonly used exposure method. This approach involves a large incision and requires multiple cuts through muscle and other soft tissues to expose the hip joint. Despite excellent outcomes, the PA is known to have an increased rate of dislocation compared to other exposures. The direct superior (DS) approach has been developed to improve the PA by decreasing the amount of soft tissue injury at the time of surgery and improving postoperative stability. The DS approach involves a much shorter incision and reduces the need to damage as much soft tissues surrounding the hip joint during exposure. Specialized equipment developed for this technique allows the surgeon to place the hip replacement components. The proposed research study is designed to address a deficit in knowledge regarding outcomes on patients who have had a DS approach for total hip arthroplasty. This study will provide much needed insight into the advantages and disadvantages of the DS approach as compared to PA for total hip arthroplasty.

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (2)

• EQ-5D patient reported outcome measure

  Health status measure

  2 years

• Oxford-12 patient reported outcome measure

  Functional outcome measure

  2 years

Secondary Outcomes (1)

• Length of stay

  0 - 30 days

Study Arms (2)

Direct Superior Approach

EXPERIMENTAL

The intervention being tested is the surgical approach.

Procedure: Direct Superior Approach; Device: Total Hip Arthroplasty

Posterior Approach

ACTIVE COMPARATOR

Device: Total Hip Arthroplasty; Procedure: Posterior Approach

Interventions

Direct Superior Approach PROCEDURE

Total hip arthroplasty using direct superior approach

Direct Superior Approach

Total Hip Arthroplasty DEVICE

Total Hip Arthroplasty using direct superior or posterior approach

Direct Superior Approach; Posterior Approach

Posterior Approach PROCEDURE

Total Hip Arthroplasty using posterior approach

Posterior Approach

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic osteoarthritis of the hip indicating surgical intervention
• Uncemented femoral stem and acetabular cup indicated
• Patients between the ages of 18 and 80, inclusive.
• Ability to give informed consent

You may not qualify if:

• Patients less than 18 years of age, or 81 years of age and older
• Active or prior infection of the affected hip
• Morbid obesity (BMI \> 45)
• Medical condition precluding major surgery
• Severe osteoporosis or osteopenia
• Neuromuscular impairment
• Patients with known or tested-positive allergy to metals
• Pregnancy

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 24, 2017
• Study Start: July 10, 2018
• Primary Completion: July 10, 2025
• Study Completion: December 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)