Surgical Site InfectionNCT02734134
One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection
A study testing One-stage exchange joint replacement surgery and Two-stage exchange joint replacement surgery in people with Surgical Site Infection, run by OrthoCarolina Research Institute, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to compare the outcomes of two different treatment options commonly used to manage periprosthetic joint infection (PJI), an infection around the artificial knee or hip. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- One-stage exchange joint replacement surgery and Two-stage exchange joint replacement surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 May 2016to 7 Jan 2026
- 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
- Patients >18 years old
- Patients who speak English and are willing to sign the consent form
- Patients with chronic infection of a total knee or total hip arthroplasty, defined as:
- A sinus communicating with the prosthesis
- Two positive cultures obtained from the prosthesis
- 3 of 5 criteria: (i) Elevated erythrocyte sedimentation rate (ESR) (>30mm/jr) and c-reactive protein (CRP) (>10mg/L) (ii) Elevated synovial leukocyte count (>3000 cells/µL) or change of ++ on leukocyte esterase strip (iii) Elevated synovial neutrophil percentage (>80%) (iv) One positive culture (v) Positive histological analysis of periprosthetic tissue (>5 neutrophils per high power field in 5 high power fields x400)
- Patients with a previous irrigation and debridement for periprosthetic infection
Who cannot join
- Culture negative infections whereby the infecting organism has not identified
- Patients with systemic sepsis who require emergent surgery
- Patients with extensive soft tissue involvement that would preclude the closure of the wound after reimplantation, if the patient were to undergo the one-stage exchange
- Patients with acute PJI or acute hematogenous PJI, defined as:
- Presentation of systems <4 weeks from index procedure
- Presentation of systems <4 week duration
Show all 10Show fewer
- Fungal infections
- Resistant organisms not sensitive to available IV antibiotics, oral antibiotics, or heat stable antibiotic additives to bone cement with documented elution characteristics
- Revision surgery or previous two-stage reimplant
- HIV positive patients or patients on chemotherapy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
OrthoCarolina Research Institue
Charlotte, North Carolina, 28207
Midwest Orthopaedics at Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
Hospital for Special Surgery
New York, New York, 10021
Rothman Institute at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
The purpose of this study is to compare the outcomes of two different treatment options commonly used to manage periprosthetic joint infection (PJI), an infection around the artificial knee or hip.
Read the detailed description
Total joint arthroplasty (TJA) is a very common and successful procedure, and is expected to become more prevalent in the upcoming years. However, despite its success, TJA is associated with some complications, including periprosthetic joint infection (PJI). PJI is a devastating complication that is associated with marked patient morbidity and mortality and is an immense economic burden. Although the rate of PJI following a TJA is low, the burden is rising exponentially due to health complications and treatment costs. There are two common types of surgical treatments that can be used to treat chronic PJI, a two-stage exchange arthroplasty and a one-stage exchange arthroplasty. During a two-stage exchange arthroplasty, the implants are removed, infected tissues are debrided and a temporary antibiotic impregnated spacer fashioned from polymethylmethacrylate is placed (stage one). Afterwards the patient undergoes many weeks of intravenous antibiotics, followed by reimplantation at a later date (stage two). During the time between the first and second stage of the revision patients are often immobile, experience severe pain due to a lack of functioning joint, and may experience systemic toxicity associated with the administration of antibiotics. In a one stage exchange arthroplasty, the infected prosthesis is removed, infected tissues are debrided, and a new prosthesis is reimplanted during the same procedure.
While the two-stage exchange arthroplasty is the preferred method of treatment for chronic PJI in North America, the one-stage exchange arthroplasty is the method of choice in Europe and some centers have reported comparable results in terms of success for one-stage exchange to two-stage exchange arthroplasty. However, there has been no randomized, prospective, controlled study to date that compares one-stage exchange to two-stage exchange arthroplasty. Because of the lack of comparative outcome reports, and the perceived higher rate of failure of one-stage exchange arthroplasty, surgeons in North America prefer to perform the traditional two-stage exchange arthroplasty for management of chronic PJI. Several teams have succeeded in performing a one-stage exchange arthroplasty in selected patients, but this procedure has not gained much popularity in the US.
The purpose of this study is to investigate the outcome of one-stage and two-stage exchange arthroplasty for the management of patients with chronic PJI. The hypothesis of this study is that one-stage exchange arthroplasty, if performed in the appropriate patient population, carries a similar success rate for the treatment of chronic PJI as two-stage exchange arthroplasty and avoids many of the problems associated with two-stage exchange arthroplasty.
- Conditions
- Surgical Site Infection
- Being tested
- One-stage exchange joint replacement surgery, Two-stage exchange joint replacement surgery
- Keywords
- Periprosthetic joint infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-stage exchange joint replacement surgeryProcedure or surgery
Two-stage exchange joint replacement surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| One-stage exchange | Active comparator | One surgery where the infected implants are removed and the hip or knee joint are 'washed out' before new joint replacement implants are re-implanted during the same surgical procedure. Receives: Procedure: One-stage exchange joint replacement surgery |
| Two-stage exchange | Active comparator | Two surgeries; during the first surgery the infected implants are removed and a spacer is placed in the hip or knee joint in place of the implants. A second surgery to re-implant the hip or knee joint replacement implants is performed if and when the infection has cleared. Receives: Procedure: Two-stage exchange joint replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of infection
The primary outcome measured will be the recurrence of infection by the same organism or reinfection with a new organism as determined by the criteria using the International Consensus Meeting on PJI (1 year follow-up).
Measured: 1 year following treatment
Secondary outcomes (3)
Health Related Quality of Health
All patients will complete the Veteran's Rand - 12 (VR-12) which is a general health measure. The VR-12 also yields a health utility measure that can be used to calculate quality-adjusted life years in an economic cost-utility analysis.
Measured: 2 years following surgery
Patient-Reported Functional Outcomes
Hip patients will complete the Hip disability and Osteoarthritis Outcome Score (HOOS), Junior which is a region-specific measure of pain and function of the hip.
Measured: 2 years following surgery
Patient-Reported Functional Outcomes
Knee patients will complete the Knee injury and Osteoarthritis Outcome Score (KOOS) Junior which is a region-specific measure of pain and function of the knee.
Measured: 2 years following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start18 May 2016
- Primary completionDec 2024
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies 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
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, Hospital for Special Surgery, New York, Rothman Institute at Thomas Jefferson University, Midwest Orthopaedics Rush University Medical Center, Vanderbilt University, Emory University, University of Iowa, Carilion Clinic, University of Southern California, Ochsner Health System, Cleveland Clinic Florida, University of Utah, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Thomas K Fehring, MD, Principal investigator, Attending Hip & Knee Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734134
- Sponsor's protocol ID
- 1106
- Status last verified
- May 2026
- First submitted
- 23 Mar 2016
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zmistowski B, Karam JA, Durinka JB, Casper DS, Parvizi J. Periprosthetic joint infection increases the risk of one-year mortality. J Bone Joint Surg Am. 2013 Dec 18;95(24):2177-84. doi: 10.2106/JBJS.L.00789.
PubMed 24352771Luu A, Syed F, Raman G, Bhalla A, Muldoon E, Hadley S, Smith E, Rao M. Two-stage arthroplasty for prosthetic joint infection: a systematic review of acute kidney injury, systemic toxicity and infection control. J Arthroplasty. 2013 Oct;28(9):1490-8.e1. doi: 10.1016/j.arth.2013.02.035. Epub 2013 Apr 8.
PubMed 23578491Nickinson RS, Board TN, Gambhir AK, Porter ML, Kay PR. The microbiology of the infected knee arthroplasty. Int Orthop. 2010 Apr;34(4):505-10. doi: 10.1007/s00264-009-0797-y. Epub 2009 May 21.
PubMed 19458950El Helou OC, Berbari EF, Marculescu CE, El Atrouni WI, Razonable RR, Steckelberg JM, Hanssen AD, Osmon DR. Outcome of enterococcal prosthetic joint infection: is combination systemic therapy superior to monotherapy? Clin Infect Dis. 2008 Oct 1;47(7):903-9. doi: 10.1086/591536.
PubMed 18754743Parvizi J, Zmistowski B, Adeli B. Periprosthetic joint infection: treatment options. Orthopedics. 2010 Sep 7;33(9):659. doi: 10.3928/01477447-20100722-42.
PubMed 20839679Parkinson RW, Kay PR, Rawal A. A case for one-stage revision in infected total knee arthroplasty? Knee. 2011 Jan;18(1):1-4. doi: 10.1016/j.knee.2010.04.008. Epub 2010 Aug 17.
PubMed 20719522von Foerster G, Kluber D, Kabler U. [Mid- to long-term results after treatment of 118 cases of periprosthetic infections after knee joint replacement using one-stage exchange surgery]. Orthopade. 1991 Jun;20(3):244-52. German.
PubMed 1876406Buechel FF, Femino FP, D'Alessio J. Primary exchange revision arthroplasty for infected total knee replacement: a long-term study. Am J Orthop (Belle Mead NJ). 2004 Apr;33(4):190-8; discussion 198.
PubMed 15132327Singer J, Merz A, Frommelt L, Fink B. High rate of infection control with one-stage revision of septic knee prostheses excluding MRSA and MRSE. Clin Orthop Relat Res. 2012 May;470(5):1461-71. doi: 10.1007/s11999-011-2174-6. Epub 2011 Nov 12.
PubMed 22081299Ure KJ, Amstutz HC, Nasser S, Schmalzried TP. Direct-exchange arthroplasty for the treatment of infection after total hip replacement. An average ten-year follow-up. J Bone Joint Surg Am. 1998 Jul;80(7):961-8. doi: 10.2106/00004623-199807000-00004.
PubMed 9698000Leunig M, Chosa E, Speck M, Ganz R. A cement spacer for two-stage revision of infected implants of the hip joint. Int Orthop. 1998;22(4):209-14. doi: 10.1007/s002640050244.
PubMed 9795805Pattyn C, De Geest T, Ackerman P, Audenaert E. Preformed gentamicin spacers in two-stage revision hip arthroplasty: functional results and complications. Int Orthop. 2011 Oct;35(10):1471-6. doi: 10.1007/s00264-010-1172-8. Epub 2010 Nov 30.
PubMed 21116817Berend KR, Lombardi AV Jr, Morris MJ, Bergeson AG, Adams JB, Sneller MA. Two-stage treatment of hip periprosthetic joint infection is associated with a high rate of infection control but high mortality. Clin Orthop Relat Res. 2013 Feb;471(2):510-8. doi: 10.1007/s11999-012-2595-x.
PubMed 22983683Diaz-Ledezma C, Higuera CA, Parvizi J. Success after treatment of periprosthetic joint infection: a Delphi-based international multidisciplinary consensus. Clin Orthop Relat Res. 2013 Jul;471(7):2374-82. doi: 10.1007/s11999-013-2866-1. Epub 2013 Feb 26.
PubMed 23440616Berry DJ, Harmsen WS, Cabanela ME, Morrey BF. Twenty-five-year survivorship of two thousand consecutive primary Charnley total hip replacements: factors affecting survivorship of acetabular and femoral components. J Bone Joint Surg Am. 2002 Feb;84(2):171-7. doi: 10.2106/00004623-200202000-00002.
PubMed 11861721
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection
- ClinicalTrials.gov ID
- NCT02734134
- Acronym / sponsor ID
- 1106
- Conditions
- Surgical Site Infection
- Keywords
- Periprosthetic joint infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Collaborators
- The Cleveland Clinic, Hospital for Special Surgery, New York, Rothman Institute at Thomas Jefferson University, Midwest Orthopaedics Rush University Medical Center, Vanderbilt University, Emory University, University of Iowa, Carilion Clinic, University of Southern California, Ochsner Health System, Cleveland Clinic Florida, University of Utah, University of California, San Francisco
- Study start
- 18 May 2016 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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.
The purpose of this study is to compare the outcomes of two different treatment options commonly used to manage periprosthetic joint infection (PJI), an infection around the artificial knee or hip.
Detailed description
Total joint arthroplasty (TJA) is a very common and successful procedure, and is expected to become more prevalent in the upcoming years. However, despite its success, TJA is associated with some complications, including periprosthetic joint infection (PJI). PJI is a devastating complication that is associated with marked patient morbidity and mortality and is an immense economic burden. Although the rate of PJI following a TJA is low, the burden is rising exponentially due to health complications and treatment costs. There are two common types of surgical treatments that can be used to treat chronic PJI, a two-stage exchange arthroplasty and a one-stage exchange arthroplasty. During a two-stage exchange arthroplasty, the implants are removed, infected tissues are debrided and a temporary antibiotic impregnated spacer fashioned from polymethylmethacrylate is placed (stage one). Afterwards the patient undergoes many weeks of intravenous antibiotics, followed by reimplantation at a later date (stage two). During the time between the first and second stage of the revision patients are often immobile, experience severe pain due to a lack of functioning joint, and may experience systemic toxicity associated with the administration of antibiotics. In a one stage exchange arthroplasty, the infected prosthesis is removed, infected tissues are debrided, and a new prosthesis is reimplanted during the same procedure.
While the two-stage exchange arthroplasty is the preferred method of treatment for chronic PJI in North America, the one-stage exchange arthroplasty is the method of choice in Europe and some centers have reported comparable results in terms of success for one-stage exchange to two-stage exchange arthroplasty. However, there has been no randomized, prospective, controlled study to date that compares one-stage exchange to two-stage exchange arthroplasty. Because of the lack of comparative outcome reports, and the perceived higher rate of failure of one-stage exchange arthroplasty, surgeons in North America prefer to perform the traditional two-stage exchange arthroplasty for management of chronic PJI. Several teams have succeeded in performing a one-stage exchange arthroplasty in selected patients, but this procedure has not gained much popularity in the US.
The purpose of this study is to investigate the outcome of one-stage and two-stage exchange arthroplasty for the management of patients with chronic PJI. The hypothesis of this study is that one-stage exchange arthroplasty, if performed in the appropriate patient population, carries a similar success rate for the treatment of chronic PJI as two-stage exchange arthroplasty and avoids many of the problems associated with two-stage exchange arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-stage exchange | Active comparator | Procedure: One-stage exchange joint replacement surgeryOne surgery where the infected implants are removed and the hip or knee joint are 'washed out' before new joint replacement implants are re-implanted during the same surgical procedure. |
| Two-stage exchange | Active comparator | Procedure: Two-stage exchange joint replacement surgeryTwo surgeries; during the first surgery the infected implants are removed and a spacer is placed in the hip or knee joint in place of the implants. A second surgery to re-implant the hip or knee joint replacement implants is performed if and when the infection has cleared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients >18 years old
- Patients who speak English and are willing to sign the consent form
- Patients with chronic infection of a total knee or total hip arthroplasty, defined as:
- Patients with a previous irrigation and debridement for periprosthetic infection
Key exclusion criteria (10 listed)
- Culture negative infections whereby the infecting organism has not identified
- Patients with systemic sepsis who require emergent surgery
- Patients with extensive soft tissue involvement that would preclude the closure of the wound after reimplantation, if the patient were to undergo the one-stage exchange
- Patients with acute PJI or acute hematogenous PJI, defined as:
- Fungal infections
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 |
|---|---|---|
| One-stage exchange joint replacement surgery | Procedure or surgery | One-stage exchange |
| Two-stage exchange joint replacement surgery | Procedure or surgery | Two-stage exchange |
Primary outcome
Recurrence of infection
Time frame: 1 year following treatment
The primary outcome measured will be the recurrence of infection by the same organism or reinfection with a new organism as determined by the criteria using the International Consensus Meeting on PJI (1 year follow-up).
3 secondary outcomes
Health Related Quality of Health
Time frame: 2 years following surgery
Patient-Reported Functional Outcomes
Time frame: 2 years following surgery
Patient-Reported Functional Outcomes
Time frame: 2 years following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 24352771Zmistowski B, Karam JA, Durinka JB, Casper DS, Parvizi J. Periprosthetic joint infection increases the risk of one-year mortality. J Bone Joint Surg Am. 2013 Dec 18;95(24):2177-84. doi: 10.2106/JBJS.L.00789.
- Background: PubMed 23578491Luu A, Syed F, Raman G, Bhalla A, Muldoon E, Hadley S, Smith E, Rao M. Two-stage arthroplasty for prosthetic joint infection: a systematic review of acute kidney injury, systemic toxicity and infection control. J Arthroplasty. 2013 Oct;28(9):1490-8.e1. doi: 10.1016/j.arth.2013.02.035. Epub 2013 Apr 8.
- Background: PubMed 19458950Nickinson RS, Board TN, Gambhir AK, Porter ML, Kay PR. The microbiology of the infected knee arthroplasty. Int Orthop. 2010 Apr;34(4):505-10. doi: 10.1007/s00264-009-0797-y. Epub 2009 May 21.
- Background: PubMed 18754743El Helou OC, Berbari EF, Marculescu CE, El Atrouni WI, Razonable RR, Steckelberg JM, Hanssen AD, Osmon DR. Outcome of enterococcal prosthetic joint infection: is combination systemic therapy superior to monotherapy? Clin Infect Dis. 2008 Oct 1;47(7):903-9. doi: 10.1086/591536.
- Background: PubMed 20839679Parvizi J, Zmistowski B, Adeli B. Periprosthetic joint infection: treatment options. Orthopedics. 2010 Sep 7;33(9):659. doi: 10.3928/01477447-20100722-42.
- Background: PubMed 20719522Parkinson RW, Kay PR, Rawal A. A case for one-stage revision in infected total knee arthroplasty? Knee. 2011 Jan;18(1):1-4. doi: 10.1016/j.knee.2010.04.008. Epub 2010 Aug 17.
- Background: PubMed 1876406von Foerster G, Kluber D, Kabler U. [Mid- to long-term results after treatment of 118 cases of periprosthetic infections after knee joint replacement using one-stage exchange surgery]. Orthopade. 1991 Jun;20(3):244-52. German.
- Background: PubMed 15132327Buechel FF, Femino FP, D'Alessio J. Primary exchange revision arthroplasty for infected total knee replacement: a long-term study. Am J Orthop (Belle Mead NJ). 2004 Apr;33(4):190-8; discussion 198.
- Background: PubMed 22081299Singer J, Merz A, Frommelt L, Fink B. High rate of infection control with one-stage revision of septic knee prostheses excluding MRSA and MRSE. Clin Orthop Relat Res. 2012 May;470(5):1461-71. doi: 10.1007/s11999-011-2174-6. Epub 2011 Nov 12.
- Background: PubMed 9698000Ure KJ, Amstutz HC, Nasser S, Schmalzried TP. Direct-exchange arthroplasty for the treatment of infection after total hip replacement. An average ten-year follow-up. J Bone Joint Surg Am. 1998 Jul;80(7):961-8. doi: 10.2106/00004623-199807000-00004.
- Background: PubMed 9795805Leunig M, Chosa E, Speck M, Ganz R. A cement spacer for two-stage revision of infected implants of the hip joint. Int Orthop. 1998;22(4):209-14. doi: 10.1007/s002640050244.
- Background: PubMed 21116817Pattyn C, De Geest T, Ackerman P, Audenaert E. Preformed gentamicin spacers in two-stage revision hip arthroplasty: functional results and complications. Int Orthop. 2011 Oct;35(10):1471-6. doi: 10.1007/s00264-010-1172-8. Epub 2010 Nov 30.
- 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.
Thomas K Fehring, MD principal investigator
Attending Hip & Knee Surgeon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-stage exchange joint replacement surgery and Two-stage exchange joint replacement surgery in people with Surgical Site Infection, run by OrthoCarolina Research Institute, Inc. at 5 sites in United States.
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 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of infection (time frame: 1 year following treatment). 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 NCT02734134, which also lists 17 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 22 May 2026.