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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

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.

Condition or disease Intervention/treatment Phase
Prosthetic Joint Infection of the Knee Device: Static Antibiotic Spacer Surgical Implant Device: Articulating Antibiotic Spacer Surgical Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Static Versus Articulating Antibiotic Spacer for Treatment of Periprosthetic Joint Infection in Total Knee Arthroplasty
Study Start Date : September 2015
Actual Primary Completion Date : January 23, 2017
Actual Study Completion Date : January 23, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: Static Antibiotic Spacer Surgical Implant
Joint spacer for treatment of joint infection

Active Comparator: 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.
Device: Articulating Antibiotic Spacer Surgical Implant
Joint spacer for treatment of joint infection




Primary Outcome Measures :
  1. Number of Subjects With Repeat Infections [ Time Frame: 1 year post-operatively ]
    The rate of repeat infections after re-implantation Total Knee Arthroplasty.

  2. 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.


Secondary Outcome Measures :
  1. Pre-operative Range of Motion (ROM) [ Time Frame: baseline ]
    The degree of knee flexion was measured pre-operatively.

  2. Post-operative Range of Motion (ROM) [ Time Frame: 1 year post-operatively ]
    The degree of knee flexion was measured one year post-operatively.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547129


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael Taunton, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Michael J. Taunton, M.D., Mayo Clinic:

Additional Information:
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Responsible Party: Michael J. Taunton, M.D., Assistant Professor of Orthopedics, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02547129     History of Changes
Other Study ID Numbers: 12-003291
First Posted: September 11, 2015    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents