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

NCT ID: NCT04191993

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2022-12-31

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.

Conditions

Surgery; Surgical Incision; Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Direct Superior Approach (DSA)

Direct superior incision during surgery

Group Type: EXPERIMENTAL

Total hip arthroplasty

Intervention Type: DEVICE

Surgical intervention designed to replace arthritic joint with artificial implant

Posterior Approach (PA)

Posterior approach incision during surgery

Group Type: ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type: DEVICE

Surgical intervention designed to replace arthritic joint with artificial implant

Interventions

Total hip arthroplasty

Surgical intervention designed to replace arthritic joint with artificial implant

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University College London Hospital NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32560737 (View on PubMed)

Other Identifiers

17/0426

Identifier Type: -

Identifier Source: org_study_id