Direct Superior Approach (DSA) vs Posterior Approach (PA) in THA
Primary Purpose
Surgery, Surgical Incision, Patient Satisfaction
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Total hip arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Surgery focused on measuring Total hip arthroplasty, Direct superior approach, Minimally invasive surgery, Implant position, Osteoarthritis, Posterior approach, Radiostereometric analysis
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
Sites / Locations
- University College London Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Direct Superior Approach (DSA)
Posterior Approach (PA)
Arm Description
Direct superior incision during surgery
Posterior approach incision during surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Operating time
Operating time in minutes
Time to discharge
Time to discharge in hours
Analgesia requirements
Analgesia requirements
Oxford Hip Score (OHS)
Patient recorded outcome measure via questionnaire. 48 is best score and 0 worst score
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%
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
Harris Hip Score [HHS]
Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome
Mobilisation distance
Mobilisation distance in metres
Use of mobility aids
Use of mobility aids
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.
Full Information
NCT ID
NCT04191993
First Posted
December 6, 2019
Last Updated
June 27, 2023
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT04191993
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Surgical Incision, Patient Satisfaction
Keywords
Total hip arthroplasty, Direct superior approach, Minimally invasive surgery, Implant position, Osteoarthritis, Posterior approach, Radiostereometric analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Direct Superior Approach (DSA)
Arm Type
Experimental
Arm Description
Direct superior incision during surgery
Arm Title
Posterior Approach (PA)
Arm Type
Active Comparator
Arm Description
Posterior approach incision during surgery
Intervention Type
Device
Intervention Name(s)
Total hip arthroplasty
Intervention Description
Surgical intervention designed to replace arthritic joint with artificial implant
Primary Outcome Measure Information:
Title
Pain in hip at 24 hours following surgery
Description
Pain at 24 hours following surgery as assessed using the visual analogue scale between patients undergoing PA for THA versus DSA for THA.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Operating time
Description
Operating time in minutes
Time Frame
During the operation
Title
Time to discharge
Description
Time to discharge in hours
Time Frame
6 weeks post operation
Title
Analgesia requirements
Description
Analgesia requirements
Time Frame
inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Title
Oxford Hip Score (OHS)
Description
Patient recorded outcome measure via questionnaire. 48 is best score and 0 worst score
Time Frame
Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Title
Hip injury and osteoarthritis outcome score (KOOS)
Description
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%
Time Frame
Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Title
European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
Description
Patient recorded outcome measure with 5 domains; score -1 to 1, with 1 being best score
Time Frame
Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Title
Harris Hip Score [HHS]
Description
Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome
Time Frame
Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Title
Mobilisation distance
Description
Mobilisation distance in metres
Time Frame
inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Title
Use of mobility aids
Description
Use of mobility aids
Time Frame
inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Title
Femoral and acetabular implant early migration
Description
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.
Time Frame
postoperatively at 2 weeks, 6 weeks, 6 months, 1 year, and 2 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University College London Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plans
Citations:
PubMed Identifier
32560737
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.
Results Reference
derived
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Direct Superior Approach (DSA) vs Posterior Approach (PA) in THA
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