Use of Corticosteroid in Intraopertive Injections in Total Knee Replacement Surgery.
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWalter Reed National Military Medical Center
About this trial
The goal of this clinical trial is to find out which type of steroid medicine, when added to a standard pain-control injection during total knee replacement surgery, works best at reducing pain, limiting opioid use, and improving recovery in adults undergoing surgery for severe knee arthritis or injury.
The main questions it aims to answer are:
Does adding a steroid to the injection improve pain control and reduce opioid use after surgery? Is the newer extended-release steroid (Zilretta) more effective and safer-especially for patients with diabetes-than the traditional steroid (methylprednisolone)?
Researchers will compare:
Standard pain-control injection alone Standard injection plus methylprednisolone Standard injection plus Zilretta to see which option provides better pain relief, less opioid use, and improved knee function.
(Patients with diabetes or prediabetes will only be in the standard injection or Zilretta groups so researchers can study whether Zilretta is safer for blood sugar control.)
Participants will:
Be randomly assigned to one of the study groups during their total knee replacement surgery Receive the assigned pain-control injection around the knee joint
Be followed after surgery to measure:
Pain levels Opioid pain medication use Knee movement (range of motion) Whether another procedure (such as manipulation under anesthesia) is needed if the knee becomes too stiff Patient-reported outcome surveys about pain and function
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients within the MHS who are DEERS eligible undergoing primary TKA at Walter Reed National Military Medical Center (WRNMMC), Surgery Center of Chevy Chase or District Surgery Center
Age 18 or older
successful surgical intervention
Disqualifiers
Unicompartmental knee arthroplasty (UKA)
Revision total knee arthroplasty (rTKA)
Females who are pregnant or nursing
Allergic to ingredients in PAI or previous adverse reaction to steroids being used in this study
Trial design
Design model
Parallel
Treatments tested in this trial
PAI
DrugStandard PAI: 30 mg Toradol/ketorolac (30mg/ml), 49.25ml 0.5% ropivacaine (5mg/ml), and 0.5 mg
PAI + steroid
DrugStandard PAI + 40mg methylprednisolone (n = 40)
PAI + zilretta
DrugStandard PAI + 32mg Zilretta (triamcinolone acetonide extended release injectable suspension)
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: Standard PAIActive comparator 1 intervention
Group B: MethylprednisoloneActive comparator 1 intervention
Group C: ZilrettaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The primary outcome is to determine whether total knee arthroplasty outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone.
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Improvement in pain levels postoperatively based on measurement of pain intensity using a Visual Analogue Scale (VAS) at 24hrs, 72 hours, and 7 days (all phone call), and 28 days
Time frame
24 hours, 72 hours, 7 days, and 28 days post2
Postoperative ROM
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: Change in range of motion (ROM) at 28, 120 and 365 days postop
Time frame
28, 120 and 365 days postop3
Patient reported outcome measure
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) score at 120 and 365 days postoperatively
Time frame
120 and 365 days postoperatively4
Patient reported outcome measures 2
The following outcomes after total knee arthroplasty will be compared to determine whether outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone: • Change in Single Assessment Numeric Evaluation (SANE) score at 120 and 365 days postop
Time frame
120 and 365 days postopSecondary outcomes
1
Adverse events and subgroup analysis
To determine whether the adverse event rates associated with Zilretta and methylprednisolone are significantly less than the adverse event rates for standard PAI.
Time frame
28 days, 120 days, 365 days postopSponsors and contacts
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Source ClinicalTrials.gov