Clinical trial NCT04191993: Direct Superior Approach (DSA) vs Posterior Approach (PA) in THA
Official title: A Prospective Randomised Controlled Trial Comparing the Direct Superior Approach Versus the Posterior Approach for Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Surgical Incision
Patient Satisfaction
Keywords: Total hip arthroplasty
Direct superior approach
Minimally invasive surgery
Implant position
Osteoarthritis
Posterior approach
Radiostereometric analysis
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain in hip at 24 hours following surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Operating time
timeFrame: During the operation
measure: Time to discharge
timeFrame: 6 weeks post operation
measure: Analgesia requirements
timeFrame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Oxford Hip Score (OHS)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Hip injury and osteoarthritis outcome score (KOOS)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Harris Hip Score [HHS]
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Mobilisation distance
timeFrame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Use of mobility aids
timeFrame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Femoral and acetabular implant early migration
timeFrame: postoperatively at 2 weeks, 6 weeks, 6 months, 1 year, and 2 years.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust
Study officials:
References:
citation: Kayani B, Konan S, Tahmassebi J, Ayuob A, Haddad FS. The direct superior approach versus posterior approach for total hip arthroplasty: study protocol for a prospective double-blinded randomised control trial. Trials. 2020 Jun 19;21(1):546. doi: 10.1186/s13063-020-04484-y.