Total Hip ArthroplastyNCT03227549
Investigating the Direct Superior Approach for Total Hip Arthroplasty as an Effective Alternative to Traditional Posterior Approach
A study testing Direct Superior Approach, Total Hip Arthroplasty and Posterior Approach in people with Total Hip Arthroplasty, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Hip replacement surgery is an effective option for treating pain and functional impairment in chronic hip conditions. Various surgical approaches have been developed to expose the hip joint for the procedure, each with advantages and disadvantages. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Direct Superior Approach, Total Hip Arthroplasty and Posterior Approach
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jul 2018to Dec 2025
- 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 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic osteoarthritis of the hip indicating surgical intervention
- Uncemented femoral stem and acetabular cup indicated
- Patients between the ages of 18 and 80, inclusive.
- Ability to give informed consent
Who cannot join
- Patients less than 18 years of age, or 81 years of age and older
- Active or prior infection of the affected hip
- Morbid obesity (BMI > 45)
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
- Neuromuscular impairment
- Patients with known or tested-positive allergy to metals
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Hip replacement surgery is an effective option for treating pain and functional impairment in chronic hip conditions. Various surgical approaches have been developed to expose the hip joint for the procedure, each with advantages and disadvantages. The posterior approach (PA) to total hip replacement is a commonly used exposure method. This approach involves a large incision and requires multiple cuts through muscle and other soft tissues to expose the hip joint. Despite excellent outcomes, the PA is known to have an increased rate of dislocation compared to other exposures. The direct superior (DS) approach has been developed to improve the PA by decreasing the amount of soft tissue injury at the time of surgery and improving postoperative stability. The DS approach involves a much shorter incision and reduces the need to damage as much soft tissues surrounding the hip joint during exposure. Specialized equipment developed for this technique allows the surgeon to place the hip replacement components. The proposed research study is designed to address a deficit in knowledge regarding outcomes on patients who have had a DS approach for total hip arthroplasty. This study will provide much needed insight into the advantages and disadvantages of the DS approach as compared to PA for total hip arthroplasty.
Read the detailed description
The primary objective of this study is to compare the health status and functional outcomes of patients who have undergone total hip arthroplasty (THA) utilizing the direct superior (DS) approach to those who have undergone THA utilizing the posterior approach (PA). The aim is to quantify changes in functional status using accelerometer-based gait analysis and self-reported questionnaires, and to assess peri-operative recovery including narcotic use, length of stay, blood loss, complications and readmission for any reason.
It is hypothesized that patients who undergo THA utilizing the DS approach will have more favorable results in terms of health status and functional outcomes when compared to those who receive the PA approach. It is expected that patients in the DS group will display an earlier improvement in gait postoperatively, will have a shorter length of stay in hospital, and will have decreased postoperative pain as measured by narcotic use. No measurable difference in the position of the THA implants is expected between groups.
The proposed clinical study is a prospective randomized trial of 80 patients undergoing total hip arthroplasty utilizing either a PA or DS approach. Postoperative outcomes including narcotic use, length of stay and complications will be abstracted from the chart and any readmissions will be documented. Follow-up exams will occur at 6 weeks, 6 months, 12 months and 24 months from time of surgery. Radiographic evaluation will be performed at each interval to assess the position of the implants. Gait symmetry data will be collected pre-operatively as well as at 6 months, 12 months, and 24 months and will be assessed for longitudinal changes in characteristics such as stride frequency, envelope, surge, lurch and functional leg length discrepancy. Health status, functional outcome, and patient quality of life measures will be recorded at all follow-up intervals. Joint function will be assessed before and after surgery using the EuroQol questionnaire, Oxford 12 Hip questionnaire, Self-Administered Comorbidity Questionnaire (SCQ), visual analogue scales (VAS) for pain and satisfaction, and UCLA Activity Level Scale. Rates of infection, instability and revision for any cause will be monitored for the duration of the 2 year follow-up.
Pre-operative subject characteristics will be compared between groups using Student's t-tests (unpaired, two-sided). For the post-operative follow-up questionnaire and radiographic data, two-way repeated measures analyses of variance (ANOVA) for group differences will be used to analyze data collected at multiple time points. Gait data will be analyzed using Gaitview software.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Direct Superior Approach, Total Hip Arthroplasty, Posterior Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Superior ApproachProcedure or surgery
Total hip arthroplasty using direct superior approach
Total Hip ArthroplastyDevice
Total Hip Arthroplasty using direct superior or posterior approach
Posterior ApproachProcedure or surgery
Total Hip Arthroplasty using posterior approach
| Study group | Role | What they receive |
|---|---|---|
| Direct Superior Approach | Experimental | The intervention being tested is the surgical approach. Receives: Procedure: Direct Superior Approach; Device: Total Hip Arthroplasty |
| Posterior Approach | Active comparator | Not described Receives: Device: Total Hip Arthroplasty; Procedure: Posterior Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D patient reported outcome measure
Health status measure
Measured: 2 years
Oxford-12 patient reported outcome measure
Functional outcome measure
Measured: 2 years
Secondary outcomes (1)
Length of stay
Time until discharge from hospital following surgery
Measured: 0 - 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start10 Jul 2018
- Primary completion10 Jul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227549
- Sponsor's protocol ID
- THA DSA
- Status last verified
- Aug 2024
- First submitted
- 22 Jun 2017
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Direct Superior Approach for Total Hip Arthroplasty as an Effective Alternative to Traditional Posterior Approach
- ClinicalTrials.gov ID
- NCT03227549
- Acronym / sponsor ID
- THA DSA
- Conditions
- Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Jul 2017 (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.
Hip replacement surgery is an effective option for treating pain and functional impairment in chronic hip conditions. Various surgical approaches have been developed to expose the hip joint for the procedure, each with advantages and disadvantages. The posterior approach (PA) to total hip replacement is a commonly used exposure method. This approach involves a large incision and requires multiple cuts through muscle and other soft tissues to expose the hip joint. Despite excellent outcomes, the PA is known to have an increased rate of dislocation compared to other exposures. The direct superior (DS) approach has been developed to improve the PA by decreasing the amount of soft tissue injury at the time of surgery and improving postoperative stability. The DS approach involves a much shorter incision and reduces the need to damage as much soft tissues surrounding the hip joint during exposure. Specialized equipment developed for this technique allows the surgeon to place the hip replacement components. The proposed research study is designed to address a deficit in knowledge regarding outcomes on patients who have had a DS approach for total hip arthroplasty. This study will provide much needed insight into the advantages and disadvantages of the DS approach as compared to PA for total hip arthroplasty.
Detailed description
The primary objective of this study is to compare the health status and functional outcomes of patients who have undergone total hip arthroplasty (THA) utilizing the direct superior (DS) approach to those who have undergone THA utilizing the posterior approach (PA). The aim is to quantify changes in functional status using accelerometer-based gait analysis and self-reported questionnaires, and to assess peri-operative recovery including narcotic use, length of stay, blood loss, complications and readmission for any reason.
It is hypothesized that patients who undergo THA utilizing the DS approach will have more favorable results in terms of health status and functional outcomes when compared to those who receive the PA approach. It is expected that patients in the DS group will display an earlier improvement in gait postoperatively, will have a shorter length of stay in hospital, and will have decreased postoperative pain as measured by narcotic use. No measurable difference in the position of the THA implants is expected between groups.
The proposed clinical study is a prospective randomized trial of 80 patients undergoing total hip arthroplasty utilizing either a PA or DS approach. Postoperative outcomes including narcotic use, length of stay and complications will be abstracted from the chart and any readmissions will be documented. Follow-up exams will occur at 6 weeks, 6 months, 12 months and 24 months from time of surgery. Radiographic evaluation will be performed at each interval to assess the position of the implants. Gait symmetry data will be collected pre-operatively as well as at 6 months, 12 months, and 24 months and will be assessed for longitudinal changes in characteristics such as stride frequency, envelope, surge, lurch and functional leg length discrepancy. Health status, functional outcome, and patient quality of life measures will be recorded at all follow-up intervals. Joint function will be assessed before and after surgery using the EuroQol questionnaire, Oxford 12 Hip questionnaire, Self-Administered Comorbidity Questionnaire (SCQ), visual analogue scales (VAS) for pain and satisfaction, and UCLA Activity Level Scale. Rates of infection, instability and revision for any cause will be monitored for the duration of the 2 year follow-up.
Pre-operative subject characteristics will be compared between groups using Student's t-tests (unpaired, two-sided). For the post-operative follow-up questionnaire and radiographic data, two-way repeated measures analyses of variance (ANOVA) for group differences will be used to analyze data collected at multiple time points. Gait data will be analyzed using Gaitview software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Direct Superior Approach | Experimental | Procedure: Direct Superior Approach, Device: Total Hip ArthroplastyThe intervention being tested is the surgical approach. |
| Posterior Approach | Active comparator | Device: Total Hip Arthroplasty, Procedure: Posterior Approach |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic osteoarthritis of the hip indicating surgical intervention
- Uncemented femoral stem and acetabular cup indicated
- Patients between the ages of 18 and 80, inclusive.
- Ability to give informed consent
Key exclusion criteria (8 listed)
- Patients less than 18 years of age, or 81 years of age and older
- Active or prior infection of the affected hip
- Morbid obesity (BMI > 45)
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
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 |
|---|---|---|
| Direct Superior ApproachTotal hip arthroplasty using direct superior approach | Procedure or surgery | Direct Superior Approach |
| Total Hip ArthroplastyTotal Hip Arthroplasty using direct superior or posterior approach | Device | Direct Superior Approach, Posterior Approach |
| Posterior ApproachTotal Hip Arthroplasty using posterior approach | Procedure or surgery | Posterior Approach |
Primary outcome
EQ-5D patient reported outcome measure
Time frame: 2 years
Health status measure
Oxford-12 patient reported outcome measure
Time frame: 2 years
Functional outcome measure
1 secondary outcome
Length of stay
Time frame: 0 - 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Total Hip Arthroplasty
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
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 Direct Superior Approach, Total Hip Arthroplasty and Posterior Approach in people with Total Hip Arthroplasty, run by Nova Scotia Health Authority at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. 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 Canada. 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?
Results are not available in the source record.
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?
EQ-5D patient reported outcome measure (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2024.