SurgeryNCT04191993
Direct Superior Approach (DSA) vs Posterior Approach (PA) in THA
A study testing Total hip arthroplasty in people with Surgery and Surgical Incision, run by University College, London at 1 site in United Kingdom.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery, Surgical Incision, Patient Satisfaction
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital NHS Foundation Trust
London, NW1 2PG
About this study
Official title: A Prospective Randomised Controlled Trial Comparing the Direct Superior Approach Versus the Posterior Approach for Total Hip Arthroplasty
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
- Being tested
- Total hip arthroplasty
- Keywords
- Total hip arthroplasty, Direct superior approach, Minimally invasive surgery, Implant position, Osteoarthritis, Posterior approach, Radiostereometric analysis
- Medical subject headings
- Surgical Wound, Patient Satisfaction, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyDevice
Surgical intervention designed to replace arthritic joint with artificial implant
| Study group | Role | What they receive |
|---|---|---|
| Direct Superior Approach (DSA) | Experimental | Direct superior incision during surgery Receives: Device: Total hip arthroplasty |
| Posterior Approach (PA) | Active comparator | Posterior approach incision during surgery Receives: Device: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (10)
Operating time
Operating time in minutes
Measured: During the operation
Time to discharge
Time to discharge in hours
Measured: 6 weeks post operation
Analgesia requirements
Analgesia requirements
Measured: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Oxford Hip Score (OHS)
Patient recorded outcome measure via questionnaire. 48 is best score and 0 worst score
Measured: 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)
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%
Measured: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
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
Measured: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Harris Hip Score [HHS]
Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome
Measured: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Mobilisation distance
Mobilisation distance in metres
Measured: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Use of mobility aids
Use of mobility aids
Measured: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
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.
Measured: postoperatively at 2 weeks, 6 weeks, 6 months, 1 year, and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start12 Jun 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191993
- Sponsor's protocol ID
- 17/0426
- Status last verified
- Jun 2023
- First submitted
- 6 Dec 2019
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plans
Publications
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.
PubMed 32560737
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Trial Comparing the Direct Superior Approach Versus the Posterior Approach for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04191993
- Acronym / sponsor ID
- 17/0426
- Conditions
- Surgery, Surgical Incision, Patient Satisfaction
- Keywords
- Total hip arthroplasty, Direct superior approach, Minimally invasive surgery, Implant position, Osteoarthritis, Posterior approach, Radiostereometric analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Superior Approach (DSA) | Experimental | Device: Total hip arthroplastyDirect superior incision during surgery |
| Posterior Approach (PA) | Active comparator | Device: Total hip arthroplastyPosterior approach incision during surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has hip osteoarthritis requiring primary THA
Key exclusion criteria (8 listed)
- Patient is not suitable for primary THA e.g. patient requires revision surgery for previously failed THA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip arthroplastySurgical intervention designed to replace arthritic joint with artificial implant | Device | Direct Superior Approach (DSA), Posterior Approach (PA) |
Primary outcome
Pain in hip at 24 hours following surgery
Time frame: 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.
10 secondary outcomes
Operating time
Time frame: During the operation
Time to discharge
Time frame: 6 weeks post operation
Analgesia requirements
Time frame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Oxford Hip Score (OHS)
Time frame: 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)
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Harris Hip Score [HHS]
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Mobilisation distance
Time frame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Use of mobility aids
Time frame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Femoral and acetabular implant early migration
Time frame: postoperatively at 2 weeks, 6 weeks, 6 months, 1 year, and 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Derived from this study: PubMed 32560737Kayani 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.
- Individual participant dataSharing planned: No. No plans
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip arthroplasty in people with Surgery and Surgical Incision, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in hip at 24 hours following surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.