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Completed

NCT Number: NCT04191993

Direct Superior Approach (DSA) vs Posterior Approach (PA) in THA

Total Hip Arthroplasty (THA) is a highly effective treatment for patients with symptomatic hip osteoarthritis. The surgical approach in THA is important as it influences postoperative clinical recovery, functional outcomes, and implant positioning [1]. The evolution of surgical techniques in THA has led to the development of minimally invasive surgery, which is performed through smaller skin incisions, reduced soft tissue disruption and greater muscle preservation [2-10]. This prospective, randomised control study compares clinical and radiological outcomes in THA performed using the standard posterior approach (PA) and its less invasive modification, the direct superior approach (DSA). The study will include 80 patients with hip osteoarthritis undergoing THA. Following informed consent, patients will be randomised to one of the two treatment groups, and undergo THA using either the PA or DSA. The control group includes patients undergoing THA through the PA while the investigation group includes patients undergoing THA with the DSA. A further 25 patients randomly selected from each treatment group will undergo radiosteriometric analysis (RSA) to assess differences in early implant migration between PA and DSA groups.

Clinical and radiological outcomes of interest will be recorded by blinded observers at regular intervals for 2 years after surgery. The findings of this study will enable an improved understanding of differences in postoperative clinical recovery, functional outcomes, and implant positioning in THA performed using the DSA compared to the PA approach.

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Key information

Conditions

Surgery Arthritis Behavior Health Behavior Joint Diseases Musculoskeletal Diseases Osteoarthritis Patient Satisfaction Rheumatic Diseases Surgical Incision Surgical Wound Treatment Adherence and Compliance Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London Hospital NHS Foundation Trust

London, NW1 2PG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has hip osteoarthritis requiring primary THA
  • Patient and surgeon are in agreement that THA is the most appropriate treatment
  • Patient is fit for surgical intervention following review by surgeon and anaesthetist
  • Patient age: Patients 18-80 years of age inclusive
  • Gender: male and female
  • Patient must be capable of giving informed consent and agree to comply with the postoperative review program
  • Patient must be a permanent resident in an area accessible to the study site
  • Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken

Exclusion criteria

  • Patient is not suitable for primary THA e.g. patient requires revision surgery for previously failed THA
  • Patient is not medically fit for surgical intervention
  • Patients under the age of 18 or over 80 years of age
  • Patient is immobile or has another neurological condition affecting musculoskeletal function
  • Patient is already enrolled on another concurrent clinical trial
  • Patient is unable or unwilling to sign the informed consent form specific to this study
  • Patient is unable to attend the follow-up programme
  • Patient is non-resident in local area or expected to leave the catchment area postoperatively

Treatment and study plan

Total hip arthroplasty

Device

Surgical intervention designed to replace arthritic joint with artificial implant

Primary outcomes

  1. Pain in hip at 24 hours following surgery

    Time frame: 24 hours

    Pain at 24 hours following surgery as assessed using the visual analogue scale between patients undergoing PA for THA versus DSA for THA.

Secondary outcomes

  1. Operating time

    Time frame: During the operation

    Operating time in minutes

  2. Time to discharge

    Time frame: 6 weeks post operation

    Time to discharge in hours

  3. Analgesia requirements

    Time frame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.

    Analgesia requirements

  4. Oxford Hip Score (OHS)

    Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

    Patient recorded outcome measure via questionnaire. 48 is best score and 0 worst score

  5. Hip injury and osteoarthritis outcome score (KOOS)

    Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

    Patient recorded outcome measure via questionnaire. 6 separate domains including pain, stiffness, quality of life, symptoms, and function; each domain creates percentage with overall cumulative percentage achieved; best score 100%

  6. European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)

    Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

    Patient recorded outcome measure with 5 domains; score -1 to 1, with 1 being best score

  7. Harris Hip Score [HHS]

    Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

    Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome

  8. Mobilisation distance

    Time frame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.

    Mobilisation distance in metres

  9. Use of mobility aids

    Time frame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.

    Use of mobility aids

  10. Femoral and acetabular implant early migration

    Time frame: postoperatively at 2 weeks, 6 weeks, 6 months, 1 year, and 2 years.

    Femoral and acetabular implant early migration as assessed using radiosteriometric analysis (RSA) This RSA will be performed on a cohort of 25 randomly selected patients from each treatment group.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

A Prospective Randomised Controlled Trial Comparing the Direct Superior Approach Versus the Posterior Approach for Total Hip Arthroplasty

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Dec 10, 2019
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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