Prosthetic Joint Infection of the Knee
Conditions
Brief 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.
Interventions
DEVICEStatic Antibiotic Spacer Surgical Implant
Joint spacer for treatment of joint infection
DEVICEArticulating Antibiotic Spacer Surgical Implant
Joint spacer for treatment of joint infection
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female age 18 to 100 years of age. 2. 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. 3. Intact extensor mechanism. 4. Adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft) 5. Adequate bone stock for knee reconstruction 6. Medical fitness for staged knee reconstruction
Exclusion criteria
1. Known Atypical infection (mycobacterial or fungal) 2. Extensor mechanism disruption 3. Inadequate soft tissue envelope requiring muscle flap or skin grafting 4. Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (AORI) classification) 5. Medical status precluding staged knee reconstruction 6. Requirement for hinged knee reconstruction at the time of reimplantation 7. Pregnant women - for women of child bearing age, a negative pregnancy test will be needed prior to enrollment to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Repeat Infections | 1 year post-operatively | The rate of repeat infections after re-implantation Total Knee Arthroplasty. |
| Change in Total Knee Replacement Functional Scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-operative Range of Motion (ROM) | baseline | The degree of knee flexion was measured pre-operatively. |
| Post-operative Range of Motion (ROM) | 1 year post-operatively | The degree of knee flexion was measured one year post-operatively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Difficulty with ongoing infection | 1 | 0 |
Baseline characteristics
| Characteristic | Static Antibiotic Spacer | Articulating Antibiotic Spacer | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White/Non-Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
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.
Time frame: baseline, 1 year post-operatively
Population: Study was terminated early due to difficulty enrolling patients.
Primary
Number of Subjects With Repeat Infections
The rate of repeat infections after re-implantation Total Knee Arthroplasty.
Time frame: 1 year post-operatively
Population: Study was terminated early due to difficulty enrolling patients.
Secondary
Post-operative Range of Motion (ROM)
The degree of knee flexion was measured one year post-operatively.
Time frame: 1 year post-operatively
Population: Study was terminated early due to difficulty enrolling patients.
Secondary
Pre-operative Range of Motion (ROM)
The degree of knee flexion was measured pre-operatively.
Time frame: baseline
Population: Study was terminated early due to difficulty enrolling patients.