Trial Outcomes & Findings for Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty (NCT NCT02547129)

Results Overview

The rate of repeat infections after re-implantation Total Knee Arthroplasty.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

1 year post-operatively

Results posted on

2019-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	2	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Difficulty with ongoing infection	1	0

Baseline Characteristics

Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Static Antibiotic Spacer n=2 Participants 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 n=2 Participants 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.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White/Non-Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year post-operatively

Population: Study was terminated early due to difficulty enrolling patients.

The rate of repeat infections after re-implantation Total Knee Arthroplasty.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: baseline, 1 year post-operatively

Population: Study was terminated early due to difficulty enrolling patients.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline

Population: Study was terminated early due to difficulty enrolling patients.

The degree of knee flexion was measured pre-operatively.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year post-operatively

Population: Study was terminated early due to difficulty enrolling patients.

The degree of knee flexion was measured one year post-operatively.

Outcome measures

Outcome data not reported

Adverse Events

Static Antibiotic Spacer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Articulating Antibiotic Spacer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael J. Taunton

Mayo Clinic

Phone: 507-284-7692

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place