Total Hip ReplacementREVISITSNCT03741296
REVISITS: Revision Single or Two Stage Surgery
A study testing Single stage revision and Two-stage revision in people with Total Hip Replacement and Arthroplasty Complications, run by Unity Health Toronto.
Trial summary
Hip replacement surgery is common, with over 60,000 cases in Canada annually. After hip replacement, about 1-2% patients develop a deep infection in their artificial hip implant, called a periprosthetic joint infection (PJI). It can results in severe pain, disability and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement, Arthroplasty Complications
- What is being tested?
- Single stage revision and Two-stage revision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 years or above
- A clinical diagnosis of deep hip periprosthetic joint infection according to the Musculoskeletal Infection Society criteria
- Require revision surgery (either single-or two-stage revision) for hip periprosthetic joint infection in the opinion of the treating consultant orthopaedic surgeon
- The patient is not a candidate for Debridement, Antibiotics and Implant Retention (DAIR) treatment with retention of the implant
- Willing and able to sign the written consent, follow the protocol and attend follow-up
- Able to read and understand English
Who cannot join
- Culture-negative infection (organism not identified)
- Patients with systemic sepsis who require emergent surgery
- Resistant organisms not sensitive to available intravenous antibiotics
- Revision surgery or previous two-stage reimplant
- Unable or unwilling to undergo either single-or two-stage revision surgery
- Cognitive impairment (dementia, Alzheimer, etc.) which will prevent patients from completing the primary outcome measure
- Medical contra-indication to surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: REVISITS Trial: Revision Single or Two Stage Surgery for Periprosthetic Hip Infection - a Multicentre Randomized Clinical Trial
Hip replacement surgery is common, with over 60,000 cases in Canada annually. After hip replacement, about 1-2% patients develop a deep infection in their artificial hip implant, called a periprosthetic joint infection (PJI). It can results in severe pain, disability and death.
There are two types of surgical treatment: a single-stage revision that involves removing the joint, thoroughly cleaning the infected area and implanting a new joint, all in the same surgical procedure; a two-stage revision involves removing the joint, waiting at least 8 weeks while treating the patients with antibiotics and then doing re-implantation of the joint.
Read the detailed description
Peri-prosthetic infection is an uncommon but severe complication of joint replacement (arthroplasty) with a reported rate between 0.6 to 2.2%. Although the likelihood of infection is relatively small, the psychological and economic impact, as well as long-term implications to both the patient and healthcare system, can be catastrophic.
The current gold standard treatment for peri-prosthetic infection is a two-stage strategy, where the artificial hip joint is removed and a new replacement delayed for at least 8 weeks until clear evidence of infection eradication is obtained. During this time the patient may be non-ambulatory, non- or partial-weight bearing and then a wait for re-listing for the second surgery.
An alternative treatment that has recently been more widely used is to perform a single stage revision. That involves removing the implants and then irrigating and debriding and finally implanting the new replacements prostheses. This is all done in one surgery. The advantage of this technique is that there is only one procedure and usually the patient is allowed to bear weight on the joint.
Primary Objective:
To compare pain and physical function assessed by the Oxford hip score, between the single and two-stage revision surgery for a periprosthetic hip infection in adults
Secondary Objectives:
To compare pain, function, quality of life, rates of reinfection, complications, cost-effectiveness and health economic impact.
Tertiary Objectives:
To involve building partnerships between patients, researchers and clinicians. Patients will be engaged in the trial development and knowledge translation.
- Conditions
- Total Hip Replacement, Arthroplasty Complications
- Being tested
- Single stage revision, Two-stage revision
- Keywords
- Hip replacement, periprosthetic hip infection, single stage revision, two-stage revision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single stage revisionProcedure or surgery
One-stage exchange hip joint replacement surgery
Two-stage revisionProcedure or surgery
Two-stage exchange hip joint replacement surgery
| Study group | Role | What they receive |
|---|---|---|
| single stage revision | Active comparator | One surgery where the infected artificial joint will be removed along with all components, cement, and any potentially infected material. The surgical site will be debrided and washed out before a new artificial hip joint (prosthesis) is implanted. All the procedures will be done in a single surgery. Receives: Procedure: Single stage revision |
| two-stage revision | Active comparator | Patients will undergo 2 separated surgeries. In the first operation, the infected artificial joint will be removed along with all components, cement, and any potentially infected material. The surgical site will be debrided, washed out and a spacer will be placed in the hip (temporarily replace prosthesis).
A secondary surgery to re-implant the hip will be performed with an interval period of 4-10 weeks when the infection is cleared.
The site will be debrided and irrigated, and any component/spacer will be removed. A new artificial joint will then be implanted. Receives: Procedure: Two-stage revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported hip function
Measured by means of the Oxford Hip Score - A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after hip replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function
Measured: Questionnaire will be completed by patients at 9 months after surgery
Secondary outcomes (6)
Health status and quality of life
EuroQol-5D (EQ-5D-5L) is a questionnaire where patients self-rate their level of severity of health status and health-related quality of life. Consists of 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each one of them has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) where patients will indicate how they feel regarding their health status and quality of life.
Measured: Questionnaire will be completed by patients before the surgery and at 6, 9, 12 and 24 months after surgery
Reinfection rates
Recurrence of infection by the same organism or reinfection with a new organism as determined by the criteria using the Musculoskeletal Infection Society criteria.
- There is a sinus tract communicating with the prosthesis; or
- A pathogen is isolated by culture from at least two separate tissue or fluid samples obtained from the affected prosthetic joint; or
- Four of the following six criteria exist:
- Elevated serum erythrocyte sedimentation rate (ESR) and serum C-reactive protein (CRP) concentration
- Elevated synovial leukocyte count,
- Elevated synovial neutrophil percentage (PMN%)
- Presence of purulence in the affected joint
- Isolation of a microorganism in one culture of periprosthetic tissue or fluid
- Greater than five neutrophils per high-power field in five high-power fields observed from histologic analysis of periprosthetic tissue at 400x magnification
Measured: will be assessed at 6 weeks, 3, 6, 9,12 and 24 months after surgery
Patient-reported hip function
Measured by means of the Oxford Hip Score - A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after hip replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function
Measured: Questionnaire will be completed by patients at 12 and 24 months after surgery
Visual Analog Pain Scale
Assess pain from a visual scale that ranges from 0 to 10. Straight line with the endpoints defining extreme limits such as 'no pain at all' (zero) and 'pain as bad as it could be' (ten)
Measured: Pain scale will be assessed before the surgery and at 24 and 48 hours, 6 weeks, 3,6, 9, 12 and 24 months after surgery
Hospital readmission
If patients who were discharged after surgery have an unplanned readmission for any cause to an hospital, the reason for readmission being related or not to the surgery
Measured: Will be assessed within 30 days of discharge
Hospital length of stay
The duration of a single episode of hospitalization (in days)
Measured: Will be assessed from admission to discharge (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study startApr 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Total Hip ReplacementStudies 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
- Model description
- This is a study is a multicentre, prospective, parallel, two-arm, randomized controlled trial aiming to assess the efficacy of single stage revision peri-prosthetic joint infection of hip arthroplasty in adult's patients, compared to the current gold standard of care, two-stage revision.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Atrey, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741296
- Sponsor's protocol ID
- 18-0278
- Acronym
- REVISITS
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kunutsor SK, Whitehouse MR, Blom AW, Beswick AD; INFORM Team. Re-Infection Outcomes following One- and Two-Stage Surgical Revision of Infected Hip Prosthesis: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 25;10(9):e0139166. doi: 10.1371/journal.pone.0139166. eCollection 2015.
PubMed 26407003Lopez D, Leach I, Moore E, Norrish AR. Management of the Infected Total Hip Arthroplasty. Indian J Orthop. 2017 Jul-Aug;51(4):397-404. doi: 10.4103/ortho.IJOrtho_307_16.
PubMed 28790468Kapadia BH, Berg RA, Daley JA, Fritz J, Bhave A, Mont MA. Periprosthetic joint infection. Lancet. 2016 Jan 23;387(10016):386-394. doi: 10.1016/S0140-6736(14)61798-0. Epub 2015 Jun 28.
PubMed 26135702Dale H, Fenstad AM, Hallan G, Havelin LI, Furnes O, Overgaard S, Pedersen AB, Karrholm J, Garellick G, Pulkkinen P, Eskelinen A, Makela K, Engesaeter LB. Increasing risk of prosthetic joint infection after total hip arthroplasty. Acta Orthop. 2012 Oct;83(5):449-58. doi: 10.3109/17453674.2012.733918.
PubMed 23083433Blom AW, Taylor AH, Pattison G, Whitehouse S, Bannister GC. Infection after total hip arthroplasty. The Avon experience. J Bone Joint Surg Br. 2003 Sep;85(7):956-9. doi: 10.1302/0301-620x.85b7.14095.
PubMed 14516026Phillips JE, Crane TP, Noy M, Elliott TS, Grimer RJ. The incidence of deep prosthetic infections in a specialist orthopaedic hospital: a 15-year prospective survey. J Bone Joint Surg Br. 2006 Jul;88(7):943-8. doi: 10.1302/0301-620X.88B7.17150.
PubMed 16799001Lenguerrand E, Whitehouse MR, Beswick AD, Jones SA, Porter ML, Blom AW. Revision for prosthetic joint infection following hip arthroplasty: Evidence from the National Joint Registry. Bone Joint Res. 2017 Jun;6(6):391-398. doi: 10.1302/2046-3758.66.BJR-2017-0003.R1.
PubMed 28642256Chen SY, Hu CC, Chen CC, Chang YH, Hsieh PH. Two-Stage Revision Arthroplasty for Periprosthetic Hip Infection: Mean Follow-Up of Ten Years. Biomed Res Int. 2015;2015:345475. doi: 10.1155/2015/345475. Epub 2015 Apr 29.
PubMed 26064901Kunutsor SK, Whitehouse MR, Blom AW, Board T, Kay P, Wroblewski BM, Zeller V, Chen SY, Hsieh PH, Masri BA, Herman A, Jenny JY, Schwarzkopf R, Whittaker JP, Burston B, Huang R, Restrepo C, Parvizi J, Rudelli S, Honda E, Uip DE, Bori G, Munoz-Mahamud E, Darley E, Ribera A, Canas E, Cabo J, Cordero-Ampuero J, Redo MLS, Strange S, Lenguerrand E, Gooberman-Hill R, Webb J, MacGowan A, Dieppe P, Wilson M, Beswick AD; Global Infection Orthopaedic Management Collaboration. One- and two-stage surgical revision of peri-prosthetic joint infection of the hip: a pooled individual participant data analysis of 44 cohort studies. Eur J Epidemiol. 2018 Oct;33(10):933-946. doi: 10.1007/s10654-018-0377-9. Epub 2018 Apr 5.
PubMed 29623671Kunutsor SK, Whitehouse MR, Lenguerrand E, Blom AW, Beswick AD; INFORM Team. Re-Infection Outcomes Following One- And Two-Stage Surgical Revision of Infected Knee Prosthesis: A Systematic Review and Meta-Analysis. PLoS One. 2016 Mar 11;11(3):e0151537. doi: 10.1371/journal.pone.0151537. eCollection 2016.
PubMed 26967645
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVISITS Trial: Revision Single or Two Stage Surgery for Periprosthetic Hip Infection - a Multicentre Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03741296
- Acronym / sponsor ID
- REVISITS / 18-0278
- Conditions
- Total Hip Replacement, Arthroplasty Complications
- Keywords
- Hip replacement, periprosthetic hip infection, single stage revision, two-stage revision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 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.
Hip replacement surgery is common, with over 60,000 cases in Canada annually. After hip replacement, about 1-2% patients develop a deep infection in their artificial hip implant, called a periprosthetic joint infection (PJI). It can results in severe pain, disability and death.
There are two types of surgical treatment: a single-stage revision that involves removing the joint, thoroughly cleaning the infected area and implanting a new joint, all in the same surgical procedure; a two-stage revision involves removing the joint, waiting at least 8 weeks while treating the patients with antibiotics and then doing re-implantation of the joint.
Detailed description
Peri-prosthetic infection is an uncommon but severe complication of joint replacement (arthroplasty) with a reported rate between 0.6 to 2.2%. Although the likelihood of infection is relatively small, the psychological and economic impact, as well as long-term implications to both the patient and healthcare system, can be catastrophic.
The current gold standard treatment for peri-prosthetic infection is a two-stage strategy, where the artificial hip joint is removed and a new replacement delayed for at least 8 weeks until clear evidence of infection eradication is obtained. During this time the patient may be non-ambulatory, non- or partial-weight bearing and then a wait for re-listing for the second surgery.
An alternative treatment that has recently been more widely used is to perform a single stage revision. That involves removing the implants and then irrigating and debriding and finally implanting the new replacements prostheses. This is all done in one surgery. The advantage of this technique is that there is only one procedure and usually the patient is allowed to bear weight on the joint.
Primary Objective:
To compare pain and physical function assessed by the Oxford hip score, between the single and two-stage revision surgery for a periprosthetic hip infection in adults
Secondary Objectives:
To compare pain, function, quality of life, rates of reinfection, complications, cost-effectiveness and health economic impact.
Tertiary Objectives:
To involve building partnerships between patients, researchers and clinicians. Patients will be engaged in the trial development and knowledge translation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a study is a multicentre, prospective, parallel, two-arm, randomized controlled trial aiming to assess the efficacy of single stage revision peri-prosthetic joint infection of hip arthroplasty in adult's patients, compared to the current gold standard of care, two-stage revision.
| Arm | Type | Receives |
|---|---|---|
| single stage revision | Active comparator | Procedure: Single stage revisionOne surgery where the infected artificial joint will be removed along with all components, cement, and any potentially infected material. The surgical site will be debrided and washed out before a new artificial hip joint (prosthesis) is implanted. All the procedures will be done in a single surgery. |
| two-stage revision | Active comparator | Procedure: Two-stage revisionPatients will undergo 2 separated surgeries. In the first operation, the infected artificial joint will be removed along with all components, cement, and any potentially infected material. The surgical site will be debrided, washed out and a spacer will be placed in the hip (temporarily replace prosthesis). A secondary surgery to re-implant the hip will be performed with an interval period of 4-10 weeks when the infection is cleared. The site will be debrided and irrigated, and any component/spacer will be removed. A new artificial joint will then be implanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 18 years or above
- A clinical diagnosis of deep hip periprosthetic joint infection according to the Musculoskeletal Infection Society criteria
- Require revision surgery (either single-or two-stage revision) for hip periprosthetic joint infection in the opinion of the treating consultant orthopaedic surgeon
- The patient is not a candidate for Debridement, Antibiotics and Implant Retention (DAIR) treatment with retention of the implant
- Willing and able to sign the written consent, follow the protocol and attend follow-up
Key exclusion criteria (7 listed)
- Culture-negative infection (organism not identified)
- Patients with systemic sepsis who require emergent surgery
- Resistant organisms not sensitive to available intravenous antibiotics
- Revision surgery or previous two-stage reimplant
- Unable or unwilling to undergo either single-or two-stage revision surgery
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 |
|---|---|---|
| Single stage revisionOne-stage exchange hip joint replacement surgery | Procedure or surgery | single stage revision |
| Two-stage revisionTwo-stage exchange hip joint replacement surgery | Procedure or surgery | two-stage revision |
Primary outcome
Patient-reported hip function
Time frame: Questionnaire will be completed by patients at 9 months after surgery
Measured by means of the Oxford Hip Score - A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after hip replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function
6 secondary outcomes
Health status and quality of life
Time frame: Questionnaire will be completed by patients before the surgery and at 6, 9, 12 and 24 months after surgery
Reinfection rates
Time frame: will be assessed at 6 weeks, 3, 6, 9,12 and 24 months after surgery
Patient-reported hip function
Time frame: Questionnaire will be completed by patients at 12 and 24 months after surgery
Visual Analog Pain Scale
Time frame: Pain scale will be assessed before the surgery and at 24 and 48 hours, 6 weeks, 3,6, 9, 12 and 24 months after surgery
Hospital readmission
Time frame: Will be assessed within 30 days of discharge
Hospital length of stay
Time frame: Will be assessed from admission to discharge (up to 30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Background: PubMed 26407003Kunutsor SK, Whitehouse MR, Blom AW, Beswick AD; INFORM Team. Re-Infection Outcomes following One- and Two-Stage Surgical Revision of Infected Hip Prosthesis: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 25;10(9):e0139166. doi: 10.1371/journal.pone.0139166. eCollection 2015.
- Background: PubMed 28790468Lopez D, Leach I, Moore E, Norrish AR. Management of the Infected Total Hip Arthroplasty. Indian J Orthop. 2017 Jul-Aug;51(4):397-404. doi: 10.4103/ortho.IJOrtho_307_16.
- Background: PubMed 26135702Kapadia BH, Berg RA, Daley JA, Fritz J, Bhave A, Mont MA. Periprosthetic joint infection. Lancet. 2016 Jan 23;387(10016):386-394. doi: 10.1016/S0140-6736(14)61798-0. Epub 2015 Jun 28.
- Background: PubMed 23083433Dale H, Fenstad AM, Hallan G, Havelin LI, Furnes O, Overgaard S, Pedersen AB, Karrholm J, Garellick G, Pulkkinen P, Eskelinen A, Makela K, Engesaeter LB. Increasing risk of prosthetic joint infection after total hip arthroplasty. Acta Orthop. 2012 Oct;83(5):449-58. doi: 10.3109/17453674.2012.733918.
- Background: PubMed 14516026Blom AW, Taylor AH, Pattison G, Whitehouse S, Bannister GC. Infection after total hip arthroplasty. The Avon experience. J Bone Joint Surg Br. 2003 Sep;85(7):956-9. doi: 10.1302/0301-620x.85b7.14095.
- Background: PubMed 16799001Phillips JE, Crane TP, Noy M, Elliott TS, Grimer RJ. The incidence of deep prosthetic infections in a specialist orthopaedic hospital: a 15-year prospective survey. J Bone Joint Surg Br. 2006 Jul;88(7):943-8. doi: 10.1302/0301-620X.88B7.17150.
- Background: PubMed 28642256Lenguerrand E, Whitehouse MR, Beswick AD, Jones SA, Porter ML, Blom AW. Revision for prosthetic joint infection following hip arthroplasty: Evidence from the National Joint Registry. Bone Joint Res. 2017 Jun;6(6):391-398. doi: 10.1302/2046-3758.66.BJR-2017-0003.R1.
- Background: PubMed 26064901Chen SY, Hu CC, Chen CC, Chang YH, Hsieh PH. Two-Stage Revision Arthroplasty for Periprosthetic Hip Infection: Mean Follow-Up of Ten Years. Biomed Res Int. 2015;2015:345475. doi: 10.1155/2015/345475. Epub 2015 Apr 29.
- Background: PubMed 29623671Kunutsor SK, Whitehouse MR, Blom AW, Board T, Kay P, Wroblewski BM, Zeller V, Chen SY, Hsieh PH, Masri BA, Herman A, Jenny JY, Schwarzkopf R, Whittaker JP, Burston B, Huang R, Restrepo C, Parvizi J, Rudelli S, Honda E, Uip DE, Bori G, Munoz-Mahamud E, Darley E, Ribera A, Canas E, Cabo J, Cordero-Ampuero J, Redo MLS, Strange S, Lenguerrand E, Gooberman-Hill R, Webb J, MacGowan A, Dieppe P, Wilson M, Beswick AD; Global Infection Orthopaedic Management Collaboration. One- and two-stage surgical revision of peri-prosthetic joint infection of the hip: a pooled individual participant data analysis of 44 cohort studies. Eur J Epidemiol. 2018 Oct;33(10):933-946. doi: 10.1007/s10654-018-0377-9. Epub 2018 Apr 5.
- Background: PubMed 26967645Kunutsor SK, Whitehouse MR, Lenguerrand E, Blom AW, Beswick AD; INFORM Team. Re-Infection Outcomes Following One- And Two-Stage Surgical Revision of Infected Knee Prosthesis: A Systematic Review and Meta-Analysis. PLoS One. 2016 Mar 11;11(3):e0151537. doi: 10.1371/journal.pone.0151537. eCollection 2016.
- Individual participant dataSharing planned: Undecided
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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.
Amit Atrey, MD principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Single stage revision and Two-stage revision in people with Total Hip Replacement and Arthroplasty Complications, run by Unity Health Toronto.
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 6 inclusion and 7 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Luana Melo, PhD (416-864-6060, melol@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported hip function (time frame: Questionnaire will be completed by patients at 9 months after surgery). 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 NCT03741296, which also lists 10 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 14 Nov 2018.