Arthroplasty, Replacement, HipNCT03746925
Comparing Short-term Outcomes After Direct Anterior and SuperPATH Hip Arthroplasty Approaches
A study testing Direct Anterior Approach (DAA) and SuperPATH in people with Arthroplasty, Replacement, Hip, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This study involves comparing the outcomes after using the Direct Anterior Approach (DAA) and the Supercapsular Percutaneously Assisted Total Hip (SuperPATH) approach. These are two approaches to hip replacement that both replace hips without cutting any muscles. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Direct Anterior Approach (DAA) and SuperPATH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2019to 7 Apr 2023
- 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
- Patients undergoing unilateral THA
- Over 18 years of age and below 80
- Subject is willing and able to complete required study visits and assessments
- Subject is willing to sign the approved informed consent form
Who cannot join
- Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0kg/m2 and 102.0cm, respectively for men, and 35.0kg/m2 and 88.0cm, respectively for women at screening
- Subject is currently enrolled in another clinical investigation related to lower limbs, which could affect the endpoints of this protocol
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Subject is currently incarcerated or has impending incarceration
- Previous hip surgery or infection on ipsilateral hip
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Johanna Dobransky, jdobransky@ohri.ca
About this study
Official title: Randomized Control Trial Comparing Short-term Outcomes After Direct Anterior and SuperPATH Approaches
This study involves comparing the outcomes after using the Direct Anterior Approach (DAA) and the Supercapsular Percutaneously Assisted Total Hip (SuperPATH) approach. These are two approaches to hip replacement that both replace hips without cutting any muscles. DAA approach has been used for many years, but it has a high learning curve and can be difficult for doctors to use, it is however linked with fewer complications when performed by an experienced doctor. SuperPATH is a newer technique which has been shown in studies to be adopted with less complications even during the learning phase. It also shows cost-saving results, showing a reduced length of stay for patients and better 30-day readmission rates. There is pressure on surgeons, from both patients and administration to use techniques that spare tissue, offer early functionality without compromising long-term outcomes. The SuperPATH can meet this benchmark but uptake has been slow, the investigators believe that it is due to the learning curve shown by this approach. The senior surgeon at The Ottawa Hospital is experienced in both techniques, using a trial the investigators can compare the two techniques and help encourage surgeons to change to a procedure that has demonstrated a low complication profile.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Direct Anterior Approach (DAA), SuperPATH
- Keywords
- DAA, SuperPATH, Direct Anterior Approach, THA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Anterior Approach (DAA)Procedure or surgery
Direct Anterior Approach surgery to replace the hip.
SuperPATHProcedure or surgery
SuperPATH approach surgery to replace the hip.
| Study group | Role | What they receive |
|---|---|---|
| Direct Anterior Approach (DAA) | Active comparator | Direct Anterior Approach surgery to replace the hip. Receives: Procedure: Direct Anterior Approach (DAA) |
| SuperPATH | Experimental | SuperPATH approach surgery to replace the hip. Receives: Procedure: SuperPATH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.
Measured: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Change in Gait analysis
This is done by a biomechanics lab for a subsection of 30 patients to test their hip movements.
Measured: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Secondary outcomes (9)
Change in EQ-5D-5L
Generic health status. Each question is scored from 1-5, with 1 being no problems and 5 being severe problems. These scores are not aggregated. There are 5 questions, mobility, self-care, usual activities, pain and anxiety. The last page is asking the participant to self score their health that day out of 100.
Measured: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Change in Pre-post Hgb
Checks blood oxygen level
Measured: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
Change in Visual Analog Scale (VAS) Pain Score
To measure pain. This is a line with left most end representing no pain with the rightmost representing extreme pain. The participant puts a line where they feel that day and it is measured with a ruler to determine score out of 100. The line is 100mm long.
Measured: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
Change in Complication rates
Complications such as fractures that the participant experiences will be assessed
Measured: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Readmission rates
Any readmission rates for the participant
Measured: 3 months post-operatively
Change in Timed-up-and-go (TUG)
The time it takes for the participant to get up from a chair walk 3 metres forward and back and sit back down
Measured: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Change in Timed-Stair-Climb (TSC)
The time it takes for a participant to go up and down a flight of 10 stairs.
Measured: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Change in Range of Motion (ROM)
IR and ER ROM at flexion and extension, this is measured using a goniometer (which is an instrument that measures an angle).
Measured: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Change in X-rays (AP pelvis & lateral)
To check how their bones are faring in their hip area
Measured: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start7 Sep 2019
- Primary completion7 Jan 2023 (estimated)
- Study completion7 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- It is a 2 group, parallel study where they will be randomized into one of the two groups. One will receive SuperPATH approach and the other will receive DAA.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- MicroPort Orthopedics Inc.
- Responsible party
- Sponsor
- Investigators
- Wade Gofton, MD, FRCSC, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746925
- Sponsor's protocol ID
- SuperPATH
- Status last verified
- Aug 2022
- First submitted
- 9 Nov 2018
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To keep patient confidentiality safe.
Publications
Chow J, Penenberg B, Murphy S. Modified micro-superior percutaneously-assisted total hip: early experiences & case reports. Curr Rev Musculoskelet Med. 2011 Sep;4(3):146-50. doi: 10.1007/s12178-011-9090-y.
PubMed 21789576Della Torre PK, Fitch DA, Chow JC. Supercapsular percutaneously-assisted total hip arthroplasty: radiographic outcomes and surgical technique. Ann Transl Med. 2015 Aug;3(13):180. doi: 10.3978/j.issn.2305-5839.2015.08.04.
PubMed 26366397Gofton W, Chow J, Olsen KD, Fitch DA. Thirty-day readmission rate and discharge status following total hip arthroplasty using the supercapsular percutaneously-assisted total hip surgical technique. Int Orthop. 2015 May;39(5):847-51. doi: 10.1007/s00264-014-2587-4. Epub 2014 Nov 16.
PubMed 25398472Chow J, Fitch DA. In-hospital costs for total hip replacement performed using the supercapsular percutaneously-assisted total hip replacement surgical technique. Int Orthop. 2017 Jun;41(6):1119-1123. doi: 10.1007/s00264-016-3327-8. Epub 2016 Nov 12.
PubMed 27838761SMITH-PETERSEN MN, LARSON CB, et al. Complications of old fractures of the neck of the femur; results of treatment of vitallium-mold arthroplasty. J Bone Joint Surg Am. 1947 Jan;29(1):41-8. No abstract available.
PubMed 20284684Judet J, Judet H. [Anterior approach in total hip arthroplasty]. Presse Med. 1985 May 4;14(18):1031-3. French.
PubMed 3158949Kennon RE, Keggi JM, Wetmore RS, Zatorski LE, Huo MH, Keggi KJ. Total hip arthroplasty through a minimally invasive anterior surgical approach. J Bone Joint Surg Am. 2003;85-A Suppl 4:39-48. doi: 10.2106/00004623-200300004-00005. No abstract available.
PubMed 14652392Bal BS, Vallurupalli S. Minimally invasive total hip arthroplasty with the anterior approach. Indian J Orthop. 2008 Jul;42(3):301-8. doi: 10.4103/0019-5413.41853.
PubMed 19753156Barrett WP, Turner SE, Leopold JP. Prospective randomized study of direct anterior vs postero-lateral approach for total hip arthroplasty. J Arthroplasty. 2013 Oct;28(9):1634-8. doi: 10.1016/j.arth.2013.01.034. Epub 2013 Mar 19.
PubMed 23523485Goebel S, Steinert AF, Schillinger J, Eulert J, Broscheit J, Rudert M, Noth U. Reduced postoperative pain in total hip arthroplasty after minimal-invasive anterior approach. Int Orthop. 2012 Mar;36(3):491-8. doi: 10.1007/s00264-011-1280-0. Epub 2011 May 25.
PubMed 21611823Alecci V, Valente M, Crucil M, Minerva M, Pellegrino CM, Sabbadini DD. Comparison of primary total hip replacements performed with a direct anterior approach versus the standard lateral approach: perioperative findings. J Orthop Traumatol. 2011 Sep;12(3):123-9. doi: 10.1007/s10195-011-0144-0. Epub 2011 Jul 12.
PubMed 21748384Nakata K, Nishikawa M, Yamamoto K, Hirota S, Yoshikawa H. A clinical comparative study of the direct anterior with mini-posterior approach: two consecutive series. J Arthroplasty. 2009 Aug;24(5):698-704. doi: 10.1016/j.arth.2008.04.012. Epub 2008 Jun 13.
PubMed 18555653Anterior Total Hip Arthroplasty Collaborative Investigators; Bhandari M, Matta JM, Dodgin D, Clark C, Kregor P, Bradley G, Little L. Outcomes following the single-incision anterior approach to total hip arthroplasty: a multicenter observational study. Orthop Clin North Am. 2009 Jul;40(3):329-42. doi: 10.1016/j.ocl.2009.03.001.
PubMed 19576400Xie J, Zhang H, Wang L, Yao X, Pan Z, Jiang Q. Comparison of supercapsular percutaneously assisted approach total hip versus conventional posterior approach for total hip arthroplasty: a prospective, randomized controlled trial. J Orthop Surg Res. 2017 Sep 25;12(1):138. doi: 10.1186/s13018-017-0636-6.
PubMed 28946892Meermans G, Konan S, Das R, Volpin A, Haddad FS. The direct anterior approach in total hip arthroplasty: a systematic review of the literature. Bone Joint J. 2017 Jun;99-B(6):732-740. doi: 10.1302/0301-620X.99B6.38053.
PubMed 28566391
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Comparing Short-term Outcomes After Direct Anterior and SuperPATH Approaches
- ClinicalTrials.gov ID
- NCT03746925
- Acronym / sponsor ID
- SuperPATH
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- DAA, SuperPATH, Direct Anterior Approach, THA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- MicroPort Orthopedics Inc.
- Study start
- 7 Sep 2019 (actual)
- Primary completion
- 7 Jan 2023 (estimated)
- Study completion
- 7 Apr 2023 (estimated)
- First posted
- 20 Nov 2018 (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.
This study involves comparing the outcomes after using the Direct Anterior Approach (DAA) and the Supercapsular Percutaneously Assisted Total Hip (SuperPATH) approach. These are two approaches to hip replacement that both replace hips without cutting any muscles. DAA approach has been used for many years, but it has a high learning curve and can be difficult for doctors to use, it is however linked with fewer complications when performed by an experienced doctor. SuperPATH is a newer technique which has been shown in studies to be adopted with less complications even during the learning phase. It also shows cost-saving results, showing a reduced length of stay for patients and better 30-day readmission rates. There is pressure on surgeons, from both patients and administration to use techniques that spare tissue, offer early functionality without compromising long-term outcomes. The SuperPATH can meet this benchmark but uptake has been slow, the investigators believe that it is due to the learning curve shown by this approach. The senior surgeon at The Ottawa Hospital is experienced in both techniques, using a trial the investigators can compare the two techniques and help encourage surgeons to change to a procedure that has demonstrated a low complication profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It is a 2 group, parallel study where they will be randomized into one of the two groups. One will receive SuperPATH approach and the other will receive DAA.
| Arm | Type | Receives |
|---|---|---|
| Direct Anterior Approach (DAA) | Active comparator | Procedure: Direct Anterior Approach (DAA)Direct Anterior Approach surgery to replace the hip. |
| SuperPATH | Experimental | Procedure: SuperPATHSuperPATH approach surgery to replace the hip. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing unilateral THA
- Over 18 years of age and below 80
- Subject is willing and able to complete required study visits and assessments
- Subject is willing to sign the approved informed consent form
Key exclusion criteria (5 listed)
- Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0kg/m2 and 102.0cm, respectively for men, and 35.0kg/m2 and 88.0cm, respectively for women at screening
- Subject is currently enrolled in another clinical investigation related to lower limbs, which could affect the endpoints of this protocol
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Subject is currently incarcerated or has impending incarceration
- Previous hip surgery or infection on ipsilateral hip
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 Anterior Approach (DAA)Direct Anterior Approach surgery to replace the hip. | Procedure or surgery | Direct Anterior Approach (DAA) |
| SuperPATHSuperPATH approach surgery to replace the hip. | Procedure or surgery | SuperPATH |
Primary outcome
Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
Time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.
Change in Gait analysis
Time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
This is done by a biomechanics lab for a subsection of 30 patients to test their hip movements.
9 secondary outcomes
Change in EQ-5D-5L
Time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Change in Pre-post Hgb
Time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
Change in Visual Analog Scale (VAS) Pain Score
Time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
Change in Complication rates
Time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Readmission rates
Time frame: 3 months post-operatively
Change in Timed-up-and-go (TUG)
Time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Change in Timed-Stair-Climb (TSC)
Time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Change in Range of Motion (ROM)
Time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Change in X-rays (AP pelvis & lateral)
Time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Background: PubMed 21789576Chow J, Penenberg B, Murphy S. Modified micro-superior percutaneously-assisted total hip: early experiences & case reports. Curr Rev Musculoskelet Med. 2011 Sep;4(3):146-50. doi: 10.1007/s12178-011-9090-y.
- Background: PubMed 26366397Della Torre PK, Fitch DA, Chow JC. Supercapsular percutaneously-assisted total hip arthroplasty: radiographic outcomes and surgical technique. Ann Transl Med. 2015 Aug;3(13):180. doi: 10.3978/j.issn.2305-5839.2015.08.04.
- Background: PubMed 25398472Gofton W, Chow J, Olsen KD, Fitch DA. Thirty-day readmission rate and discharge status following total hip arthroplasty using the supercapsular percutaneously-assisted total hip surgical technique. Int Orthop. 2015 May;39(5):847-51. doi: 10.1007/s00264-014-2587-4. Epub 2014 Nov 16.
- Background: PubMed 27838761Chow J, Fitch DA. In-hospital costs for total hip replacement performed using the supercapsular percutaneously-assisted total hip replacement surgical technique. Int Orthop. 2017 Jun;41(6):1119-1123. doi: 10.1007/s00264-016-3327-8. Epub 2016 Nov 12.
- Background: PubMed 20284684SMITH-PETERSEN MN, LARSON CB, et al. Complications of old fractures of the neck of the femur; results of treatment of vitallium-mold arthroplasty. J Bone Joint Surg Am. 1947 Jan;29(1):41-8. No abstract available.
- Background: PubMed 3158949Judet J, Judet H. [Anterior approach in total hip arthroplasty]. Presse Med. 1985 May 4;14(18):1031-3. French.
- Background: PubMed 14652392Kennon RE, Keggi JM, Wetmore RS, Zatorski LE, Huo MH, Keggi KJ. Total hip arthroplasty through a minimally invasive anterior surgical approach. J Bone Joint Surg Am. 2003;85-A Suppl 4:39-48. doi: 10.2106/00004623-200300004-00005. No abstract available.
- Background: PubMed 19753156Bal BS, Vallurupalli S. Minimally invasive total hip arthroplasty with the anterior approach. Indian J Orthop. 2008 Jul;42(3):301-8. doi: 10.4103/0019-5413.41853.
- Background: PubMed 23523485Barrett WP, Turner SE, Leopold JP. Prospective randomized study of direct anterior vs postero-lateral approach for total hip arthroplasty. J Arthroplasty. 2013 Oct;28(9):1634-8. doi: 10.1016/j.arth.2013.01.034. Epub 2013 Mar 19.
- Background: PubMed 21611823Goebel S, Steinert AF, Schillinger J, Eulert J, Broscheit J, Rudert M, Noth U. Reduced postoperative pain in total hip arthroplasty after minimal-invasive anterior approach. Int Orthop. 2012 Mar;36(3):491-8. doi: 10.1007/s00264-011-1280-0. Epub 2011 May 25.
- Background: PubMed 21748384Alecci V, Valente M, Crucil M, Minerva M, Pellegrino CM, Sabbadini DD. Comparison of primary total hip replacements performed with a direct anterior approach versus the standard lateral approach: perioperative findings. J Orthop Traumatol. 2011 Sep;12(3):123-9. doi: 10.1007/s10195-011-0144-0. Epub 2011 Jul 12.
- Background: PubMed 18555653Nakata K, Nishikawa M, Yamamoto K, Hirota S, Yoshikawa H. A clinical comparative study of the direct anterior with mini-posterior approach: two consecutive series. J Arthroplasty. 2009 Aug;24(5):698-704. doi: 10.1016/j.arth.2008.04.012. Epub 2008 Jun 13.
- Individual participant dataSharing planned: No. To keep patient confidentiality safe.
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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.
Wade Gofton, MD, FRCSC principal investigator
The Ottawa Hospital
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 Anterior Approach (DAA) and SuperPATH in people with Arthroplasty, Replacement, Hip, run by Ottawa Hospital Research Institute 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 5 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 8 Aug 2022. 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?
Contact Wade Gofton, MD, FRCSC (613-798-5555 ext. 18779, wgofton@ottawahospital.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL) (time frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.). 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?
On the ClinicalTrials.gov record for NCT03746925, which also lists 21 linked publications.
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 8 Aug 2022.