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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04191993
• Other study ID #: 17/0426
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Patient Satisfaction
• Surgery
• Surgical Incision
• Surgical Wound

Intervention

Device:
• Total hip arthroplasty
Surgical intervention designed to replace arthritic joint with artificial implant

Locations

Country	Name	City	State
United Kingdom	University College London Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain in hip at 24 hours following surgery	Pain at 24 hours following surgery as assessed using the visual analogue scale between patients undergoing PA for THA versus DSA for THA.	24 hours
Secondary	Operating time	Operating time in minutes	During the operation
Secondary	Time to discharge	Time to discharge in hours	6 weeks post operation
Secondary	Analgesia requirements	Analgesia requirements	inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Secondary	Oxford Hip Score (OHS)	Patient recorded outcome measure via questionnaire. 48 is best score and 0 worst score	Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Secondary	Hip injury and osteoarthritis outcome score (KOOS)	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%	Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Secondary	European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)	Patient recorded outcome measure with 5 domains; score -1 to 1, with 1 being best score	Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Secondary	Harris Hip Score [HHS]	Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome	Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Secondary	Mobilisation distance	Mobilisation distance in metres	inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Secondary	Use of mobility aids	Use of mobility aids	inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Secondary	Femoral and acetabular implant early migration	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.	postoperatively at 2 weeks, 6 weeks, 6 months, 1 year, and 2 years.