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

NCT04191993 | Completed FDA Device

• 1 other identifier: 17/0426
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Total hip arthroplasty; Direct superior approach; Minimally invasive surgery; Implant position; Osteoarthritis; Posterior approach; Radiostereometric analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Operating time

  During the operation

• Time to discharge

  6 weeks post operation

• Analgesia requirements

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

• Oxford Hip Score (OHS)

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

• 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

Study Arms (2)

Direct Superior Approach (DSA)

EXPERIMENTAL

Direct superior incision during surgery

Device: Total hip arthroplasty

Posterior Approach (PA)

ACTIVE COMPARATOR

Posterior approach incision during surgery

Device: Total hip arthroplasty

Interventions

Total hip arthroplasty DEVICE

Surgical intervention designed to replace arthritic joint with artificial implant

Direct Superior Approach (DSA); Posterior Approach (PA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32560737 DERIVED

MeSH Terms

Conditions

Surgical Wound; Patient Satisfaction; Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Wounds and Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: June 12, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)