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Medrol Dosepak Taper for Delayed Post-op Recovery After TKA

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Status and phase

Terminated
Phase 4

Conditions

Total Knee Arthroplasty

Treatments

Drug: Methylprednisolone
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05113901
21080501

Details and patient eligibility

About

To evaluate the efficacy of a methylprednisolone taper on patients with decreased range of motion (ROM) or delayed recovery in the acute postoperative period following total knee arthroplasty (TKA).

Patients with decreased ROM or delayed recovery six weeks to three months post-TKA will improve ROM and patient-reported outcomes at two weeks post-treatment initiation of methylprednisolone taper, as compared to similar patients who receive a placebo taper.

Full description

Total knee arthroplasty (TKA) is one of the most performed and efficacious orthopaedic procedures, with an estimated 7 million people living with a total knee prosthesis in 2010.1 The number of annual TKAs is predicted to increase by 85% by 2030 and 143% by 2050, equating to 1.26 million2 and 1.5 million3 procedures per year, respectively. In recent studies, knee prostheses have demonstrated their efficacy in 10-, 20-, and 25-year survival rates of 96.1%, 89.7%4, and 82.3%5, respectively. Similarly, comparing functional and patient-reported outcomes before and after surgery have confirmed the high success rate achieved with this procedure.6-10 However, recovery following total knee arthroplasty (TKA) in the acute postoperative period is variable. Most clinical improvements are achieved within the first three months postoperatively but can continue up to one year.11 There is currently a paucity of data evaluating the efficacy of oral corticosteroids in the six-week to three-month postoperative period in slowly recovering patients.

Few treatments have been studied for patients who fail to achieve early range of motion or pain reduction milestones in the perioperative period. Periarticular and systemic corticosteroids improve pain and function in the immediate postoperative period, without an increase in adverse events.12-16 Additional doses of corticosteroids administered at 24 and 48 hours postoperatively have demonstrated greater improvements in pain and ROM compared to perioperative administration, with no difference in complication rates.17-20 However, few studies have evaluated the use of oral corticosteroids within a multimodal pain management regimen. Gardiner et al. evaluated low-dose steroids 10 days immediately following lumbar laminectomy and/or discectomy, in addition to a standard opioid regimen, and reported decreased subjective pain scores.21 Gottshalk et al. reported decreased patient reported pain from postoperative days 4-7 in early published results of a randomized controlled trial investigating administration of a methylprednisolone taper immediately following distal radius repair.22 Importantly, the current literature demonstrates low- and short-dose corticosteroids are safe.23 Intraoperative corticosteroids have been shown to improve pain and function in the acute postoperative period, and additional doses in the immediate postoperative period can potentiate and prolong this beneficiary effect, without increasing adverse events. Therefore, a methylprednisolone taper six weeks post-TKA may benefit patients experiencing decreased ROM or delayed recovery, including residual pain.

Following TKA, care is taken to control pain, swelling, and stiffness, all of which may contribute to delayed recovery. For instance, more than 20% of TKA patients develop postoperative stiffness,24 known as arthrofibrosis, accounting for an estimated 28% of 90-day hospital readmissions.25 In treating patients with delayed recovery, corticosteroids are of particular interest because of its potent anti-inflammatory effect, evidenced by its ability to decrease postoperative levels of IL-6 and CRP.15 Corticosteroids block prostaglandin synthesis, which is responsible for sensitizing nociceptive pain receptors, and reduce vascular permeability, which causes edema following surgery.26, 27 Therefore, by reducing pain and edema, corticosteroids may allow for more effective physical therapy sessions and more rapid improvement in ROM and recovery following TKA.

To the best of our knowledge, this is the first study to investigate the utility of a methylprednisolone taper six weeks to three months postoperatively following TKA. The authors present a double-blinded, randomized-controlled trial evaluating the role of a methylprednisolone taper on patients with decreased ROM or delayed recovery in the acute postoperative period.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Any patient undergoing primary TKA with a diagnosis of osteoarthritis
  • ≥ 18 years old
  • ROM <90° by 3 weeks postoperatively without improvement to >90° by 6 weeks
  • Requiring a 30-pill oxycodone refill
  • NSAID allergy
  • Thigh circumference discrepancy >2cm between legs from 3 to 6 weeks
  • Defense and Veterans Pain Rating Scale (DVPRS) > 5 between 3 and 6 weeks
  • Willingness to undergo randomization

Exclusion criteria

  • Reported chronic corticosteroid or opiate use
  • Suspected or confirmed periprosthetic joint infection
  • Revision TKA
  • Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, or post-traumatic arthritis
  • American Society of Anesthesiologists (ASA) score ≥ 4
  • Reported history of liver or renal disease
  • Uncontrolled diabetes
  • Immunosuppression
  • ≤ 18 years old
  • Inability to take oral medications
  • Unable to provide consent

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

4 participants in 2 patient groups, including a placebo group

Methylprednisolone taper
Active Comparator group
Description:
21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks
Treatment:
Drug: Methylprednisolone
Placebo taper
Placebo Comparator group
Description:
21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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