Prosthetic Joint Infection of the KneeNCT02547129
Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty
A study testing Static Antibiotic Spacer Surgical Implant and Articulating Antibiotic Spacer Surgical Implant in people with Prosthetic Joint Infection of the Knee, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Prosthetic Joint Infection of the Knee
- What is being tested?
- Static Antibiotic Spacer Surgical Implant and Articulating Antibiotic Spacer Surgical Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 23 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18 to 100 years of age.
- Preoperative diagnosis of bacterial infection by culture which would include a preoperative aspiration and at least three intraoperative cultures. The preoperative aspiration would also be sent for a cell count with differential. All patients would have an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) drawn in the preoperative phase. Patients with a negative preoperative aspiration, but an actively draining wound or draining sinus tract, would be considered as infected. Intraoperative histopathology would also be obtained in all cases of infected total knee replacement at the time of the resection.
- Intact extensor mechanism.
- Adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft)
- Adequate bone stock for knee reconstruction
- Medical fitness for staged knee reconstruction
Who cannot join
- Known Atypical infection (mycobacterial or fungal)
- Extensor mechanism disruption
- Inadequate soft tissue envelope requiring muscle flap or skin grafting
- Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (AORI) classification)
- Medical status precluding staged knee reconstruction
- Requirement for hinged knee reconstruction at the time of reimplantation
- Pregnant women - for women of child bearing age, a negative pregnancy test will be needed prior to enrollment to the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Clinical Trial of Static Versus Articulating Antibiotic Spacer for Treatment of Periprosthetic Joint Infection in Total Knee Arthroplasty
The primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer.
- Conditions
- Prosthetic Joint Infection of the Knee
- Being tested
- Static Antibiotic Spacer Surgical Implant, Articulating Antibiotic Spacer Surgical Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Antibiotic Spacer Surgical ImplantDevice
Joint spacer for treatment of joint infection
Articulating Antibiotic Spacer Surgical ImplantDevice
Joint spacer for treatment of joint infection
| Study group | Role | What they receive |
|---|---|---|
| Static Antibiotic Spacer | Active comparator | Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Static Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated. Receives: Device: Static Antibiotic Spacer Surgical Implant |
| Articulating Antibiotic Spacer | Active comparator | Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Articulating Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated. Receives: Device: Articulating Antibiotic Spacer Surgical Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Repeat Infections
The rate of repeat infections after re-implantation Total Knee Arthroplasty.
Measured: 1 year post-operatively
Change in Total Knee Replacement Functional Scores
Functional scores were measured using the Knee Society Score, a clinical standard for rating the outcome of total knee replacements. Scores range from 0 -100, where a higher score reflects a more positive outcome for the subject.
Measured: baseline, 1 year post-operatively
Secondary outcomes (2)
Pre-operative Range of Motion (ROM)
The degree of knee flexion was measured pre-operatively.
Measured: baseline
Post-operative Range of Motion (ROM)
The degree of knee flexion was measured one year post-operatively.
Measured: 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion23 Jan 2017
- Study completion23 Jan 2017
Why it stopped: Difficulty enrolling patients as patients wanted articulating spacers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prosthetic Joint Infection of the KneeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Taunton, M.D., Mayo Clinic
- Investigators
- Michael Taunton, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547129
- Sponsor's protocol ID
- 12-003291
- Status last verified
- Apr 2019
- First submitted
- 18 Aug 2015
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Static Versus Articulating Antibiotic Spacer for Treatment of Periprosthetic Joint Infection in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02547129
- Acronym / sponsor ID
- 12-003291
- Conditions
- Prosthetic Joint Infection of the Knee
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling patients as patients wanted articulating spacers.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 23 Jan 2017 (actual)
- Study completion
- 23 Jan 2017 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Posted 15 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static Antibiotic Spacer | Active comparator | Device: Static Antibiotic Spacer Surgical ImplantPatient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Static Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated. |
| Articulating Antibiotic Spacer | Active comparator | Device: Articulating Antibiotic Spacer Surgical ImplantPatient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Articulating Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female age 18 to 100 years of age.
- Preoperative diagnosis of bacterial infection by culture which would include a preoperative aspiration and at least three intraoperative cultures. The preoperative aspiration would also be sent for a cell count with differential. All patients would have an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) drawn in the preoperative phase. Patients with a negative preoperative aspiration, but an actively draining wound or draining sinus tract, would be considered as infected. Intraoperative histopathology would also be obtained in all cases of infected total knee replacement at the time of the resection.
- Intact extensor mechanism.
- Adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft)
- Adequate bone stock for knee reconstruction
Key exclusion criteria (7 listed)
- Known Atypical infection (mycobacterial or fungal)
- Extensor mechanism disruption
- Inadequate soft tissue envelope requiring muscle flap or skin grafting
- Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (AORI) classification)
- Medical status precluding staged knee reconstruction
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 |
|---|---|---|
| Static Antibiotic Spacer Surgical ImplantJoint spacer for treatment of joint infection | Device | Static Antibiotic Spacer |
| Articulating Antibiotic Spacer Surgical ImplantJoint spacer for treatment of joint infection | Device | Articulating Antibiotic Spacer |
Primary outcome
Number of Subjects With Repeat Infections
Time frame: 1 year post-operatively
The rate of repeat infections after re-implantation Total Knee Arthroplasty.
Change in Total Knee Replacement Functional Scores
Time frame: baseline, 1 year post-operatively
Functional scores were measured using the Knee Society Score, a clinical standard for rating the outcome of total knee replacements. Scores range from 0 -100, where a higher score reflects a more positive outcome for the subject.
2 secondary outcomes
Pre-operative Range of Motion (ROM)
Time frame: baseline
Post-operative Range of Motion (ROM)
Time frame: 1 year post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Prosthetic Joint Infection of the Knee
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CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
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A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
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Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
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Evaluation of Arthroplasty Treatment
Surgery, Knee Arthropathy
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.
Michael Taunton, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Antibiotic Spacer Surgical Implant and Articulating Antibiotic Spacer Surgical Implant in people with Prosthetic Joint Infection of the Knee, run by Mayo Clinic at 1 site 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 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: stopped early, as of the sponsor's last update on 15 May 2019. 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 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?
Yes. Results are posted in the registry (first posted 15 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Repeat Infections (time frame: 1 year 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?
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 15 May 2019.