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

Overview

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.

Full Title of Study: “A Randomized Clinical Trial of Static Versus Articulating Antibiotic Spacer for Treatment of Periprosthetic Joint Infection in Total Knee Arthroplasty”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: January 23, 2017

Interventions

• Device: Static Antibiotic Spacer Surgical Implant
  • Joint spacer for treatment of joint infection
• Device: Articulating Antibiotic Spacer Surgical Implant
  • Joint spacer for treatment of joint infection

Arms, Groups and Cohorts

• 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.
• 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.

Clinical Trial Outcome Measures

Primary Measures

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

• Pre-operative Range of Motion (ROM)
  • Time Frame: baseline
  • The degree of knee flexion was measured pre-operatively.
• Post-operative Range of Motion (ROM)
  • Time Frame: 1 year post-operatively
  • The degree of knee flexion was measured one year post-operatively.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Mayo Clinic
• Provider of Information About this Clinical Study
  • Principal Investigator: Michael J. Taunton, M.D., Assistant Professor of Orthopedics, College of Medicine – Mayo Clinic
• Overall Official(s)
  • Michael Taunton, MD, Principal Investigator, Mayo Clinic