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Trial record 27 of 47 for:    "Prosthetic Joint Infection"

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

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ClinicalTrials.gov Identifier: NCT02547129
Recruitment Status : Terminated (Difficulty enrolling patients as patients wanted articulating spacers.)
First Posted : September 11, 2015
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Michael J. Taunton, M.D., Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prosthetic Joint Infection of the Knee
Interventions Device: Static Antibiotic Spacer Surgical Implant
Device: Articulating Antibiotic Spacer Surgical Implant
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Static Antibiotic Spacer Articulating Antibiotic Spacer
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 2 2
Completed 1 2
Not Completed 1 0
Reason Not Completed
Difficulty with ongoing infection             1             0
Arm/Group Title Static Antibiotic Spacer Articulating Antibiotic Spacer Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
2
 100.0%
2
 100.0%
4
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
1
  50.0%
1
  50.0%
2
  50.0%
Male
1
  50.0%
1
  50.0%
2
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White/Non-Hispanic or Latino Number Analyzed 2 participants 2 participants 4 participants
2
 100.0%
2
 100.0%
4
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2
 100.0%
2
 100.0%
4
 100.0%
1.Primary Outcome
Title Number of Subjects With Repeat Infections
Hide Description The rate of repeat infections after re-implantation Total Knee Arthroplasty.
Time Frame 1 year post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to difficulty enrolling patients.
Arm/Group Title Static Antibiotic Spacer Articulating Antibiotic Spacer
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change in Total Knee Replacement Functional Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to difficulty enrolling patients.
Arm/Group Title Static Antibiotic Spacer Articulating Antibiotic Spacer
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Pre-operative Range of Motion (ROM)
Hide Description The degree of knee flexion was measured pre-operatively.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to difficulty enrolling patients.
Arm/Group Title Static Antibiotic Spacer Articulating Antibiotic Spacer
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Post-operative Range of Motion (ROM)
Hide Description The degree of knee flexion was measured one year post-operatively.
Time Frame 1 year post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to difficulty enrolling patients.
Arm/Group Title Static Antibiotic Spacer Articulating Antibiotic Spacer
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Static Antibiotic Spacer Articulating Antibiotic Spacer
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Static Antibiotic Spacer Articulating Antibiotic Spacer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Static Antibiotic Spacer Articulating Antibiotic Spacer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Static Antibiotic Spacer Articulating Antibiotic Spacer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
The study was terminated early due to difficulty in enrolling patients, as patients wanted articulating spacers.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michael J. Taunton
Organization: Mayo Clinic
Phone: 507-284-7692
Responsible Party: Michael J. Taunton, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02547129     History of Changes
Other Study ID Numbers: 12-003291
First Submitted: August 18, 2015
First Posted: September 11, 2015
Results First Submitted: April 25, 2018
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019