Not provided
Not provided
Not provided
Not provided
Not provided
Difficulty enrolling patients as patients wanted articulating spacers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Static Antibiotic Spacer Surgical Implant | Device | Joint spacer for treatment of joint infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Repeat Infections | The rate of repeat infections after re-implantation Total Knee Arthroplasty. | 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. | baseline, 1 year post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-operative Range of Motion (ROM) | The degree of knee flexion was measured pre-operatively. | baseline |
| Post-operative Range of Motion (ROM) | The degree of knee flexion was measured one year post-operatively. |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Taunton, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Static Antibiotic Spacer | 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. |
| FG001 | Articulating Antibiotic Spacer | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Static Antibiotic Spacer | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Repeat Infections | The rate of repeat infections after re-implantation Total Knee Arthroplasty. | Study was terminated early due to difficulty enrolling patients. | Posted | 1 year post-operatively |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Static Antibiotic Spacer | 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. |
Not provided
Not provided
The study was terminated early due to difficulty in enrolling patients, as patients wanted articulating spacers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael J. Taunton | Mayo Clinic | 507-284-7692 | Taunton.Michael@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2018 | Jan 2, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Articulating Antibiotic Spacer Surgical Implant | Device | Joint spacer for treatment of joint infection |
|
| 1 year post-operatively |
| Articulating Antibiotic Spacer |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | 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. | Study was terminated early due to difficulty enrolling patients. | Posted | baseline, 1 year post-operatively |
|
|
| Secondary | Pre-operative Range of Motion (ROM) | The degree of knee flexion was measured pre-operatively. | Study was terminated early due to difficulty enrolling patients. | Posted | baseline |
|
|
| Secondary | Post-operative Range of Motion (ROM) | The degree of knee flexion was measured one year post-operatively. | Study was terminated early due to difficulty enrolling patients. | Posted | 1 year post-operatively |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Articulating Antibiotic Spacer | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
Not provided