Osteoarthritis, HipNCT05393778
Measured vs Navigated Techniques in Total Hip Arthroplasty
A study testing Measured Technique and Navigated Technique in people with Osteoarthritis, Hip, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Accurate reconstruction of the native hip parameters following total hip arthroplasty is associated with improved outcome. In order to improve ability for optimum reconstruction, 3-D templating software can be utilized that provide detailed information regarding native anatomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Measured Technique and Navigated Technique
- 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
- 30 Jan 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are signed for a THA for primary or secondary osteoarthritis without overt deformity that would require revision type implants and with good enough bone quality to be listed for uncemented component implantation.
Who cannot join
- Secondary OA due to Dysplasia (Hartofilakidis >1)
- Avascular necrosis of the hip with destruction of joint structure
- Sequelae of Pediatric deformity with abnormal anatomy
- Cemented fixation of femur or acetabulum
- Previous arthroplasty-type procedure
- Previous septic arthritis of the hip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy in aChieving Optimum reconstrUction: Measured- vs. Navigation- Techniques in Hip Arthroplasty
Accurate reconstruction of the native hip parameters following total hip arthroplasty is associated with improved outcome. In order to improve ability for optimum reconstruction, 3-D templating software can be utilized that provide detailed information regarding native anatomy. In order to achieve reconstruction within acceptable parameters as per pre-operative plan, some surgeons propose the use of intra-operative devices that measure component orientation and joint reconstruction ("Measured-THA"), whilst others propose the use of navigation tools ("Navigation-THA). Both techniques have shown superiority compared to the most commonly used "freehand" technique, but no prior study has assessed for superiority between these 2 techniques. Furthermore, to-date assessment of post-operative reconstruction has not been tested in detail as post-THA assessments are based on radiographs which provide incomplete, 2-dimensional, assessments and are lacking the important axial plane reconstruction parameters. The aims of this prospective, randomized, trial are to 1. appraise the ability to achieve the pre-operative 3-D plan (as per FormusLab) through a comparison of pre-op plan to post-operative reconstruction; 2. compare ability to accurately reconstruct hip following THA between "navigated-" (IntelliJoint®) and "measured-" techniques; and in doing so it will also 3. assess the accuracy of the intra-operative assessments of reconstruction through a comparison of objective (i.e. measured) intra-operative assessments with the post-operative reconstructions achieved.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Measured Technique, Navigated Technique
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measured TechniqueProcedure or surgery
Manual intra-operative checks and tools are used to aid in component placement during surgery.
Navigated TechniqueProcedure or surgery
IntelliJoint® navigation is an imageless-based navigation system that utilizes a miniature infrared camera and microelectronics to measure hip center of rotation, acetabular inclination and version, leg length, and offset. The device provides accurate real-time data on implant positioning to aid in placement of the components during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Measured Technique | Experimental | Patients in this group will have pre-operative planning done using the measured technique. Receives: Procedure: Measured Technique |
| Navigated Technique | Experimental | Patients in this group will have pre-operative planning done using the navigated technique. Receives: Procedure: Navigated Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Assessment - Oxford Hip Score
The Oxford Hip Score will be given to patients to assess subjective measures of hip pain. Scores for each question from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome
Measured: once pre-operatively and once one-year post-operatively
Change in mobility, self-care, usual activities, pain/discomfort and anxiety/depression- EuroQol
the EuroQol (EQ-5D-5L) will be given to patients to assess subjective measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Measured: once pre-operatively and once one-year post-operatively
Change in physical, mental, and social health- PROMIS Global-10
the PROMIS Global-10 will be given to patients to assess subjective measures of physical, mental and social health. It is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. Higher scores indicate worse physical and mental health
Measured: once pre-operatively and once one-year post-operatively
Adverse Events
Serious adverse events will be monitored. This includes:
- Wound complication
- Dislocation
- Fracture
- Infection
- Re-operation
- Revision surgery
Measured: 90 days post-operatively
Secondary outcomes (4)
Accuracy of reconstruction (in mm)
A measure (in mm) of how close the planned to actual reconstruction using the aforementioned reconstruction parameters. This will be assessed using:
- Acetabular component orientation
- Accuracy of acetabular component orientation
- Accuracy of femoral version restoration
- Combined version of arthroplasty in degrees
- Accuracy of combined version restoration
- Femoral Offset in mm
- Accuracy of achieving femoral offset
- Acetabular offset in mm
- Accuracy of achieving acetabular offset
- Total offset in mm
- Accuracy of achieving total offset
- Leg Length in mm o Accuracy of achieving leg length
Measured: post-operatively (within one week post-operatively)
Comparison of margin of error
This outcome will measure what the margin of error is between intra-operatively measured values and those determined from the post-operative CT scan. This will be done using statistical analysis of data for patients in both study arms.
Measured: Through study completion, an average of 1 year
Accuracy of reconstruction on outcome
This outcome measure will assess the accuracy of reconstruction correlate with outcome (adverse events and PROMs). This will be done by analyzing accuracy as depicted by the variables in outcome measure 5, and how these measures of accuracy correlate to patient reported outcome measure scores and rates of adverse events
Measured: Through study completion, an average of 1 year
Accuracy of reconstruction (in degrees)
A measure (in degrees) of how close the planned to actual reconstruction using the aforementioned reconstruction parameters. This will be assessed using:
Acetabular component orientation (Radiographic inclination/anteversion in degrees as per Murray)
- Accuracy of acetabular component orientation (i.e. deviation from target - aim for deviation of < ±5˚) ● Femoral Component Version in degrees
- Accuracy of femoral version restoration (aim for version difference to be less than ±5˚ from pre-operative plan) ● Combined version of arthroplasty in degrees
- Accuracy of combined version restoration (sum of acetabular and femoral version; aim for combined version to be less than ±10˚ from pre-operative plan)
Measured: post-operatively (within one week post-operatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 Jan 2024
- Primary completion10 Dec 2025
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- FormusLab
- Responsible party
- Sponsor
- Investigators
- George Grammatopoulos, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393778
- Sponsor's protocol ID
- 3390
- Status last verified
- Aug 2026
- First submitted
- 10 Dec 2021
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fang CJ, Shaker JM, Ward DM, Jawa A, Mattingly DA, Smith EL. Financial Burden of Revision Hip and Knee Arthroplasty at an Orthopedic Specialty Hospital: Higher Costs and Unequal Reimbursements. J Arthroplasty. 2021 Aug;36(8):2680-2684. doi: 10.1016/j.arth.2021.03.044. Epub 2021 Mar 23.
PubMed 33840537Hu X, Zheng N, Chen Y, Dai K, Dimitriou D, Li H, Tsai TY. Optimizing the Femoral Offset for Restoring Physiological Hip Muscle Function in Patients With Total Hip Arthroplasty. Front Bioeng Biotechnol. 2021 Mar 30;9:645019. doi: 10.3389/fbioe.2021.645019. eCollection 2021.
PubMed 33869155Grammatopoulos G, Thomas GE, Pandit H, Beard DJ, Gill HS, Murray DW. The effect of orientation of the acetabular component on outcome following total hip arthroplasty with small diameter hard-on-soft bearings. Bone Joint J. 2015 Feb;97-B(2):164-72. doi: 10.1302/0301-620X.97B2.34294.
PubMed 25628277Agarwal S, Eckhard L, Walter WL, Peng A, Hatton A, Donnelly B, de Steiger R. The Use of Computer Navigation in Total Hip Arthroplasty Is Associated with a Reduced Rate of Revision for Dislocation: A Study of 6,912 Navigated THA Procedures from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am. 2021 Oct 20;103(20):1900-1905. doi: 10.2106/JBJS.20.00950.
PubMed 34143758Shon WY, Baldini T, Peterson MG, Wright TM, Salvati EA. Impingement in total hip arthroplasty a study of retrieved acetabular components. J Arthroplasty. 2005 Jun;20(4):427-35. doi: 10.1016/j.arth.2004.09.058.
PubMed 16124957Barrack RL, Krempec JA, Clohisy JC, McDonald DJ, Ricci WM, Ruh EL, Nunley RM. Accuracy of acetabular component position in hip arthroplasty. J Bone Joint Surg Am. 2013 Oct 2;95(19):1760-8. doi: 10.2106/JBJS.L.01704.
PubMed 24088968Callanan MC, Jarrett B, Bragdon CR, Zurakowski D, Rubash HE, Freiberg AA, Malchau H. The John Charnley Award: risk factors for cup malpositioning: quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relat Res. 2011 Feb;469(2):319-29. doi: 10.1007/s11999-010-1487-1.
PubMed 20717858Bosker BH, Verheyen CC, Horstmann WG, Tulp NJ. Poor accuracy of freehand cup positioning during total hip arthroplasty. Arch Orthop Trauma Surg. 2007 Jul;127(5):375-9. doi: 10.1007/s00402-007-0294-y. Epub 2007 Feb 13.
PubMed 17297597Schwarzkopf R, Muir JM, Paprosky WG, Seymour S, Cross MB, Vigdorchik JM. Quantifying Pelvic Motion During Total Hip Arthroplasty Using a New Surgical Navigation Device. J Arthroplasty. 2017 Oct;32(10):3056-3060. doi: 10.1016/j.arth.2017.04.046. Epub 2017 May 4.
PubMed 28559196Pongkunakorn A, Chatmaitri S, Diewwattanawiwat K. Use of smartphone to improve acetabular component positioning in total hip athroplasty: A comparative clinical study. J Orthop Surg (Hong Kong). 2019 Jan-Apr;27(1):2309499019825578. doi: 10.1177/2309499019825578.
PubMed 30798733Gupta R, Pathak P, Singh R, Majumdar KP. Double-Stitch Technique: A Simple and Effective Method to Minimize Limb Length Discrepancy after Total Hip Arthroplasty. Indian J Orthop. 2019 Jan-Feb;53(1):169-173. doi: 10.4103/ortho.IJOrtho_188_18.
PubMed 30905998Mitsutake R, Tanino H, Nishida Y, Higa M, Ito H. A simple angle-measuring instrument for measuring cemented stem anteversion during total hip arthroplasty. BMC Musculoskelet Disord. 2020 Feb 19;21(1):113. doi: 10.1186/s12891-020-3142-7.
PubMed 32075628Steppacher SD, Kowal JH, Murphy SB. Improving cup positioning using a mechanical navigation instrument. Clin Orthop Relat Res. 2011 Feb;469(2):423-8. doi: 10.1007/s11999-010-1553-8.
PubMed 20852974Meermans G, Van Doorn WJ, Koenraadt K, Kats J. The use of the transverse acetabular ligament for determining the orientation of the components in total hip replacement: a randomised controlled trial. Bone Joint J. 2014 Mar;96-B(3):312-8. doi: 10.1302/0301-620X.96B3.32989.
PubMed 24589784Paprosky WG, Muir JM. Intellijoint HIP(R): a 3D mini-optical navigation tool for improving intraoperative accuracy during total hip arthroplasty. Med Devices (Auckl). 2016 Nov 18;9:401-408. doi: 10.2147/MDER.S119161. eCollection 2016.
PubMed 27920583
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy in aChieving Optimum reconstrUction: Measured- vs. Navigation- Techniques in Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05393778
- Acronym / sponsor ID
- 3390
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- FormusLab
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 May 2022 (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.
Accurate reconstruction of the native hip parameters following total hip arthroplasty is associated with improved outcome. In order to improve ability for optimum reconstruction, 3-D templating software can be utilized that provide detailed information regarding native anatomy. In order to achieve reconstruction within acceptable parameters as per pre-operative plan, some surgeons propose the use of intra-operative devices that measure component orientation and joint reconstruction ("Measured-THA"), whilst others propose the use of navigation tools ("Navigation-THA). Both techniques have shown superiority compared to the most commonly used "freehand" technique, but no prior study has assessed for superiority between these 2 techniques. Furthermore, to-date assessment of post-operative reconstruction has not been tested in detail as post-THA assessments are based on radiographs which provide incomplete, 2-dimensional, assessments and are lacking the important axial plane reconstruction parameters. The aims of this prospective, randomized, trial are to 1. appraise the ability to achieve the pre-operative 3-D plan (as per FormusLab) through a comparison of pre-op plan to post-operative reconstruction; 2. compare ability to accurately reconstruct hip following THA between "navigated-" (IntelliJoint®) and "measured-" techniques; and in doing so it will also 3. assess the accuracy of the intra-operative assessments of reconstruction through a comparison of objective (i.e. measured) intra-operative assessments with the post-operative reconstructions achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measured Technique | Experimental | Procedure: Measured TechniquePatients in this group will have pre-operative planning done using the measured technique. |
| Navigated Technique | Experimental | Procedure: Navigated TechniquePatients in this group will have pre-operative planning done using the navigated technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are signed for a THA for primary or secondary osteoarthritis without overt deformity that would require revision type implants and with good enough bone quality to be listed for uncemented component implantation.
Key exclusion criteria (6 listed)
- Secondary OA due to Dysplasia (Hartofilakidis >1)
- Avascular necrosis of the hip with destruction of joint structure
- Sequelae of Pediatric deformity with abnormal anatomy
- Cemented fixation of femur or acetabulum
- Previous arthroplasty-type procedure
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 |
|---|---|---|
| Measured TechniqueManual intra-operative checks and tools are used to aid in component placement during surgery. | Procedure or surgery | Measured Technique |
| Navigated TechniqueIntelliJoint® navigation is an imageless-based navigation system that utilizes a miniature infrared camera and microelectronics to measure hip center of rotation, acetabular inclination and version, leg length, and offset. The device provides accurate real-time data on implant positioning to aid in placement of the components during surgery. | Procedure or surgery | Navigated Technique |
Primary outcome
Change in Pain Assessment - Oxford Hip Score
Time frame: once pre-operatively and once one-year post-operatively
The Oxford Hip Score will be given to patients to assess subjective measures of hip pain. Scores for each question from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome
Change in mobility, self-care, usual activities, pain/discomfort and anxiety/depression- EuroQol
Time frame: once pre-operatively and once one-year post-operatively
the EuroQol (EQ-5D-5L) will be given to patients to assess subjective measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Change in physical, mental, and social health- PROMIS Global-10
Time frame: once pre-operatively and once one-year post-operatively
the PROMIS Global-10 will be given to patients to assess subjective measures of physical, mental and social health. It is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. Higher scores indicate worse physical and mental health
Adverse Events
Time frame: 90 days post-operatively
Serious adverse events will be monitored. This includes: * Wound complication * Dislocation * Fracture * Infection * Re-operation * Revision surgery
4 secondary outcomes
Accuracy of reconstruction (in mm)
Time frame: post-operatively (within one week post-operatively)
Comparison of margin of error
Time frame: Through study completion, an average of 1 year
Accuracy of reconstruction on outcome
Time frame: Through study completion, an average of 1 year
Accuracy of reconstruction (in degrees)
Time frame: post-operatively (within one week post-operatively)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 33840537Fang CJ, Shaker JM, Ward DM, Jawa A, Mattingly DA, Smith EL. Financial Burden of Revision Hip and Knee Arthroplasty at an Orthopedic Specialty Hospital: Higher Costs and Unequal Reimbursements. J Arthroplasty. 2021 Aug;36(8):2680-2684. doi: 10.1016/j.arth.2021.03.044. Epub 2021 Mar 23.
- Background: PubMed 33869155Hu X, Zheng N, Chen Y, Dai K, Dimitriou D, Li H, Tsai TY. Optimizing the Femoral Offset for Restoring Physiological Hip Muscle Function in Patients With Total Hip Arthroplasty. Front Bioeng Biotechnol. 2021 Mar 30;9:645019. doi: 10.3389/fbioe.2021.645019. eCollection 2021.
- Background: PubMed 25628277Grammatopoulos G, Thomas GE, Pandit H, Beard DJ, Gill HS, Murray DW. The effect of orientation of the acetabular component on outcome following total hip arthroplasty with small diameter hard-on-soft bearings. Bone Joint J. 2015 Feb;97-B(2):164-72. doi: 10.1302/0301-620X.97B2.34294.
- Background: PubMed 34143758Agarwal S, Eckhard L, Walter WL, Peng A, Hatton A, Donnelly B, de Steiger R. The Use of Computer Navigation in Total Hip Arthroplasty Is Associated with a Reduced Rate of Revision for Dislocation: A Study of 6,912 Navigated THA Procedures from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am. 2021 Oct 20;103(20):1900-1905. doi: 10.2106/JBJS.20.00950.
- Background: PubMed 16124957Shon WY, Baldini T, Peterson MG, Wright TM, Salvati EA. Impingement in total hip arthroplasty a study of retrieved acetabular components. J Arthroplasty. 2005 Jun;20(4):427-35. doi: 10.1016/j.arth.2004.09.058.
- Background: PubMed 24088968Barrack RL, Krempec JA, Clohisy JC, McDonald DJ, Ricci WM, Ruh EL, Nunley RM. Accuracy of acetabular component position in hip arthroplasty. J Bone Joint Surg Am. 2013 Oct 2;95(19):1760-8. doi: 10.2106/JBJS.L.01704.
- Background: PubMed 20717858Callanan MC, Jarrett B, Bragdon CR, Zurakowski D, Rubash HE, Freiberg AA, Malchau H. The John Charnley Award: risk factors for cup malpositioning: quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relat Res. 2011 Feb;469(2):319-29. doi: 10.1007/s11999-010-1487-1.
- Background: PubMed 17297597Bosker BH, Verheyen CC, Horstmann WG, Tulp NJ. Poor accuracy of freehand cup positioning during total hip arthroplasty. Arch Orthop Trauma Surg. 2007 Jul;127(5):375-9. doi: 10.1007/s00402-007-0294-y. Epub 2007 Feb 13.
- Background: PubMed 28559196Schwarzkopf R, Muir JM, Paprosky WG, Seymour S, Cross MB, Vigdorchik JM. Quantifying Pelvic Motion During Total Hip Arthroplasty Using a New Surgical Navigation Device. J Arthroplasty. 2017 Oct;32(10):3056-3060. doi: 10.1016/j.arth.2017.04.046. Epub 2017 May 4.
- Background: PubMed 30798733Pongkunakorn A, Chatmaitri S, Diewwattanawiwat K. Use of smartphone to improve acetabular component positioning in total hip athroplasty: A comparative clinical study. J Orthop Surg (Hong Kong). 2019 Jan-Apr;27(1):2309499019825578. doi: 10.1177/2309499019825578.
- Background: PubMed 30905998Gupta R, Pathak P, Singh R, Majumdar KP. Double-Stitch Technique: A Simple and Effective Method to Minimize Limb Length Discrepancy after Total Hip Arthroplasty. Indian J Orthop. 2019 Jan-Feb;53(1):169-173. doi: 10.4103/ortho.IJOrtho_188_18.
- Background: PubMed 32075628Mitsutake R, Tanino H, Nishida Y, Higa M, Ito H. A simple angle-measuring instrument for measuring cemented stem anteversion during total hip arthroplasty. BMC Musculoskelet Disord. 2020 Feb 19;21(1):113. doi: 10.1186/s12891-020-3142-7.
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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.
George Grammatopoulos, MD 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 Measured Technique and Navigated Technique in people with Osteoarthritis, 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Pain Assessment - Oxford Hip Score (time frame: once pre-operatively and once one-year post-operatively). The study lists 4 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 NCT05393778, which also lists 39 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 2 Sep 2026.