One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02734134|
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Procedure: One-stage exchange joint replacement surgery Procedure: Two-stage exchange joint replacement surgery||Not Applicable|
Total joint arthroplasty (TJA) is a very common and successful procedure, and is expected to become more prevalent in the upcoming years. However, despite its success, TJA is associated with some complications, including periprosthetic joint infection (PJI). PJI is a devastating complication that is associated with marked patient morbidity and mortality and is an immense economic burden. Although the rate of PJI following a TJA is low, the burden is rising exponentially due to health complications and treatment costs. There are two common types of surgical treatments that can be used to treat chronic PJI, a two-stage exchange arthroplasty and a one-stage exchange arthroplasty. During a two-stage exchange arthroplasty, the implants are removed, infected tissues are debrided and a temporary antibiotic impregnated spacer fashioned from polymethylmethacrylate is placed (stage one). Afterwards the patient undergoes many weeks of intravenous antibiotics, followed by reimplantation at a later date (stage two). During the time between the first and second stage of the revision patients are often immobile, experience severe pain due to a lack of functioning joint, and may experience systemic toxicity associated with the administration of antibiotics. In a one stage exchange arthroplasty, the infected prosthesis is removed, infected tissues are debrided, and a new prosthesis is reimplanted during the same procedure.
While the two-stage exchange arthroplasty is the preferred method of treatment for chronic PJI in North America, the one-stage exchange arthroplasty is the method of choice in Europe and some centers have reported comparable results in terms of success for one-stage exchange to two-stage exchange arthroplasty. However, there has been no randomized, prospective, controlled study to date that compares one-stage exchange to two-stage exchange arthroplasty. Because of the lack of comparative outcome reports, and the perceived higher rate of failure of one-stage exchange arthroplasty, surgeons in North America prefer to perform the traditional two-stage exchange arthroplasty for management of chronic PJI. Several teams have succeeded in performing a one-stage exchange arthroplasty in selected patients, but this procedure has not gained much popularity in the US.
The purpose of this study is to investigate the outcome of one-stage and two-stage exchange arthroplasty for the management of patients with chronic PJI. The hypothesis of this study is that one-stage exchange arthroplasty, if performed in the appropriate patient population, carries a similar success rate for the treatment of chronic PJI as two-stage exchange arthroplasty and avoids many of the problems associated with two-stage exchange arthroplasty.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||308 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Active Comparator: One-stage exchange
One surgery where the infected implants are removed and the hip or knee joint are 'washed out' before new joint replacement implants are re-implanted during the same surgical procedure.
Procedure: One-stage exchange joint replacement surgery
Active Comparator: Two-stage exchange
Two surgeries; during the first surgery the infected implants are removed and a spacer is placed in the hip or knee joint in place of the implants. A second surgery to re-implant the hip or knee joint replacement implants is performed if and when the infection has cleared.
Procedure: Two-stage exchange joint replacement surgery
- Recurrence of infection [ Time Frame: 1 year following treatment ]The primary outcome measured will be the recurrence of infection by the same organism or reinfection with a new organism as determined by the criteria using the International Consensus Meeting on PJI (1 year follow-up).
- Health Related Quality of Health [ Time Frame: 2 years following surgery ]All patients will complete the Veteran's Rand - 12 (VR-12) which is a general health measure. The VR-12 also yields a health utility measure that can be used to calculate quality-adjusted life years in an economic cost-utility analysis.
- Patient-Reported Functional Outcomes [ Time Frame: 2 years following surgery ]Hip patients will complete the Hip disability and Osteoarthritis Outcome Score (HOOS), Junior which is a region-specific measure of pain and function of the hip.
- Patient-Reported Functional Outcomes [ Time Frame: 2 years following surgery ]Knee patients will complete the Knee injury and Osteoarthritis Outcome Score (KOOS) Junior which is a region-specific measure of pain and function of the knee.
- Death [ Time Frame: 2 years ]Death within two years of surgical treatment for periprosthetic joint infection.
- Percentage of patients requiring surgical revision for causes other than infection [ Time Frame: Two years ]Revision of prosthetic joint for causes other than infection (e.g. hematoma, spacer dislocation).
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): NCT02734134
|Contact: Susan M Odum, PhDfirstname.lastname@example.org|
|Contact: Christi Cadd, MBAemail@example.com|
|United States, Illinois|
|Midwest Orthopaedics at Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Craig Della Valle, MD 877-632-6637|
|United States, New York|
|Hospital for Special Surgery||Recruiting|
|New York, New York, United States, 10021|
|Contact: Michael B Cross, MD 212-606-1000|
|United States, North Carolina|
|OrthoCarolina Research Institue||Recruiting|
|Charlotte, North Carolina, United States, 28207|
|Contact: Susan M Odum, PhD 704-323-2265 firstname.lastname@example.org|
|Contact: Christi Cadd, MBA 704-323-2260 email@example.com|
|Principal Investigator: Thomas K. Fehring, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Carlos Higuera, MD 216-444-2606|
|United States, Pennsylvania|
|Rothman Institute at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Javad Parvizi, MD 800-321-9999|
|Principal Investigator:||Thomas K Fehring, MD||Attending Hip & Knee Surgeon|