Medrol Dosepak Taper for Delayed Post-op Recovery After TKA

NCT05113901 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 21080501
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty

Keywords

Methylprednisolone; Delayed recover; range of motion

Outcome Measures

Primary Outcomes (1)

• Range of Motion in Degrees at Pre and Post Treatment

  Range of motion (ROM) from pre-treatment to six weeks following treatment. Patients started treatment after total knee replacement surgery and presented to clinic with at least one inclusion criteria to be enrolled. Range of motion in degrees is taken at each visit by a clinician (standard of care), starting at zero degrees (straight leg) to about 135 degrees. The ROM was documented as part of consenting and enrollment into study. Subjects returned to the office at 6 weeks post treatment where ROM was performed in a clinic setting once again and documented. ROM is done using a goniometer by a clinician in each clinic. This study was terminated early, therefore of the 4 enrolled, zero were randomized to the placebo group. Only 1 of the four subjects completed the 6 weeks, however, ROM was captured on all as standard of care.

  Baseline, Week 6 Following Treatment

Secondary Outcomes (17)

• Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)

  6 weeks post treatment

• Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores

  pre treatment

• Patient Reported Outcome Measures: Post Treatment Pain Scores

  3 weeks post treatment

• Patient Reported Outcome Measures: Post Treatment Pain Scores

  6 weeks post treatment

• Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores

  Days 1 through 6 following treatment

Study Arms (2)

Methylprednisolone taper

ACTIVE COMPARATOR

21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks

Drug: Methylprednisolone

Placebo taper

PLACEBO COMPARATOR

21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks

Drug: Placebo

Interventions

Methylprednisolone DRUG

21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks

Methylprednisolone taper

Placebo DRUG

21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks

Placebo taper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (38)

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MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Methylprednisolone Taper to Treat Delayed Post-Operative Recovery After Total Knee Arthroplasty: a D
• Organization: Rush University Medical Center

anne.debenedetti@rushortho.com

3124322468

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopedic Surgery

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: November 9, 2021
• Study Start: March 3, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 25, 2022
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)