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

Sponsor

University College, London (Other)

Overall Status

Recruiting

CT.gov ID

NCT04191993

Collaborator

(none)

Enrollment

Location

Arms

54.6

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Surgical Incision Patient Satisfaction	Device: Total hip arthroplasty	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 12, 2018

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Direct Superior Approach (DSA) Direct superior incision during surgery	Device: Total hip arthroplasty Surgical intervention designed to replace arthritic joint with artificial implant
Active Comparator: Posterior Approach (PA) Posterior approach incision during surgery	Device: Total hip arthroplasty Surgical intervention designed to replace arthritic joint with artificial implant

Arm

Intervention/Treatment

Experimental: Direct Superior Approach (DSA)

Direct superior incision during surgery

Device: Total hip arthroplasty

Surgical intervention designed to replace arthritic joint with artificial implant

Active Comparator: Posterior Approach (PA)

Posterior approach incision during surgery

Device: Total hip arthroplasty

Surgical intervention designed to replace arthritic joint with artificial implant

Outcome Measures

Primary Outcome Measures

Pain in hip at 24 hours following surgery [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 Outcome Measures

Operating time [During the operation]
Operating time in minutes
Time to discharge [6 weeks post operation]
Time to discharge in hours
Analgesia requirements [inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.]
Analgesia requirements
Oxford Hip Score (OHS) [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
Hip injury and osteoarthritis outcome score (KOOS) [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%
European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D) [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
Harris Hip Score [HHS] [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
Mobilisation distance [inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.]
Mobilisation distance in metres
Use of mobility aids [inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.]
Use of mobility aids
Femoral and acetabular implant early migration [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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