Total Knee ArthroplastyPhase 4NCT05113901
Medrol Dosepak Taper for Delayed Post-op Recovery After TKA
A Phase 4 study testing Methylprednisolone in people with Total Knee Arthroplasty, run by Rush University Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Methylprednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 25 Jul 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Uncontrolled diabetes
- Immunosuppression
- ≤ 18 years old
- Inability to take oral medications
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University medical Center
Chicago, Illinois, 60612
About this study
Official title: Methylprednisolone Taper to Treat Delayed Post-Operative Recovery After Total Knee Arthroplasty: a Double-Blind Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Methylprednisolone, Placebo
- Keywords
- Methylprednisolone, Delayed recover, range of motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM <90° at 8 weeks
PlaceboDrug
21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM <90° at 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone taper | Active comparator | 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM <90° at 8 weeks Receives: Drug: Methylprednisolone |
| Placebo taper | Placebo comparator | 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM <90° at 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6 Following Treatment
Secondary outcomes (17)
Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)
Using daily defense and veterans pain rating scale (DVPRS) on a scale of 1 to 10, 10 being the worst.
Please note, only one patient made it to the 6 week post treatment mark of the 4 enrolled. The study was terminated and none of the patients were randomized to the placebo group. All other patients followed up but were not interested in continuing. No range could be provided given only one subject answered and completed this visit
Measured: 6 weeks post treatment
Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores
Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee
**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group.
Measured: pre treatment
Patient Reported Outcome Measures: Post Treatment Pain Scores
Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee.
**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group. At 3 weeks post treatment, only 3 of the 4 subjects enrolled were still part of the study.
Measured: 3 weeks post treatment
Patient Reported Outcome Measures: Post Treatment Pain Scores
Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee.
**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group. This is a standard of care survey available on all subjects.
Measured: 6 weeks post treatment
Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores
Using Daily Visual Analogue Scale (VAS) pain score, which measures intensity of pain on a scale of 0 (no pain) to 10 (worst pain possible).
**Please note, this study was terminated early, only enrolling 4 patients, none were randomized to the placebo group.
Measured: Days 1 through 6 following treatment
Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), a survey given to patients standard of care containing 7 questions. The score ranges from 0 to 100 where zero represents total disability and 100 represents a perfect knee health.
Measured: pre treatment
Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), a survey given to patients standard of care containing 7 questions. The score ranges from 0 to 100 where zero represents total disability and 100 represents a perfect knee health.
Measured: 6 weeks after treatment
Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
Veterans Rand 12-Item Health Survey (VR-12), a survey of 12 questions to measure health relating to patient's quality of life. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome.
Measured: pre treatment
Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome.
Measured: 6 weeks after treatment
Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
Single Assessment Numeric Evaluation (SANE), a single-question patient rating of 0-100, scoring their function to the area being treated. Zero represents a poor functional knee and 100 is the best functioning.
Measured: pre treatment
Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
Single Assessment Numeric Evaluation (SANE), a single-question patient rating of 0-100, scoring their function to the area being treated. Zero represents a poor functional knee and 100 is the best functioning.
Measured: 6 weeks after treatment
Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
Forgotten Joint Score (FJS) is a survey scored ranging from 0 to 100, where a high score indicates a high degree of a forgetting they have an artificial joint, which is an ideal outcome.
Measured: pre treatment
Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment
Forgotten Joint Score (FJS) is a survey scored ranging from 0 to 100, where a high score indicates a high degree of a forgetting they have an artificial joint, which is an ideal outcome.
Measured: 6 weeks after treatment
Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
UCLA activity score, on a scale of 1 to 10 where 10 is the most active patient with examples of activities
Measured: pre treatment
Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
UCLA activity score, on a scale of 1 to 10 where 10 is the most active patient with examples of activities
Measured: 6 weeks after treatment
Number of Participants With Complications Following Treatment
Manipulations under anesthesia (MUAs) following total knee arthroplasty surgery and treatment
Measured: within 90 days after initial total knee arthroplasty
Adverse Events or Outcomes Outside of Manipulations Under Anesthesia
Adverse outcomes including infection, avascular necrosis, and 90-day readmission rates
Measured: within 90 days after initial total knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start3 Mar 2022
- Primary completion1 Jul 2022
- Study completion25 Jul 2022
Why it stopped: Extremely low participation, decided to focus on similar study instead
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasili Karas, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113901
- Sponsor's protocol ID
- 21080501
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2021
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.
PubMed 28801208Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA, Jiranek WA, Berry DJ. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am. 2015 Sep 2;97(17):1386-97. doi: 10.2106/JBJS.N.01141.
PubMed 26333733Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.
PubMed 30180053Bayliss LE, Culliford D, Monk AP, Glyn-Jones S, Prieto-Alhambra D, Judge A, Cooper C, Carr AJ, Arden NK, Beard DJ, Price AJ. The effect of patient age at intervention on risk of implant revision after total replacement of the hip or knee: a population-based cohort study. Lancet. 2017 Apr 8;389(10077):1424-1430. doi: 10.1016/S0140-6736(17)30059-4. Epub 2017 Feb 14.
PubMed 28209371Evans JT, Evans JP, Walker RW, Blom AW, Whitehouse MR, Sayers A. How long does a hip replacement last? A systematic review and meta-analysis of case series and national registry reports with more than 15 years of follow-up. Lancet. 2019 Feb 16;393(10172):647-654. doi: 10.1016/S0140-6736(18)31665-9. Epub 2019 Feb 14.
PubMed 30782340Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994 May 4;271(17):1349-57.
PubMed 8158821Ethgen O, Bruyere O, Richy F, Dardennes C, Reginster JY. Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. J Bone Joint Surg Am. 2004 May;86(5):963-74. doi: 10.2106/00004623-200405000-00012.
PubMed 15118039Heath EL, Ackerman IN, Cashman K, Lorimer M, Graves SE, Harris IA. Patient-reported outcomes after hip and knee arthroplasty : results from a large national registry. Bone Jt Open. 2021 Jun;2(6):422-432. doi: 10.1302/2633-1462.26.BJO-2021-0053.R1.
PubMed 34182793Shan L, Shan B, Suzuki A, Nouh F, Saxena A. Intermediate and long-term quality of life after total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Am. 2015 Jan 21;97(2):156-68. doi: 10.2106/JBJS.M.00372.
PubMed 25609443Kane RL, Saleh KJ, Wilt TJ, Bershadsky B. The functional outcomes of total knee arthroplasty. J Bone Joint Surg Am. 2005 Aug;87(8):1719-24. doi: 10.2106/JBJS.D.02714.
PubMed 16085610Kagan R, Anderson MB, Christensen JC, Peters CL, Gililland JM, Pelt CE. The Recovery Curve for the Patient-Reported Outcomes Measurement Information System Patient-Reported Physical Function and Pain Interference Computerized Adaptive Tests After Primary Total Knee Arthroplasty. J Arthroplasty. 2018 Aug;33(8):2471-2474. doi: 10.1016/j.arth.2018.03.020. Epub 2018 Mar 17.
PubMed 29656980Deng Z, Li Y, Storm GR, Kotian RN, Sun X, Lei G, Gao S, Lu W. The efficiency and safety of steroid addition to multimodal cocktail periarticular injection in knee joint arthroplasty: a meta-analysis of randomized controlled trials. Sci Rep. 2019 May 7;9(1):7031. doi: 10.1038/s41598-019-43540-9.
PubMed 31065018Li Q, Mu G, Liu X, Chen M. Efficacy of additional corticosteroids to multimodal cocktail periarticular injection in total knee arthroplasty: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2021 Jan 22;16(1):77. doi: 10.1186/s13018-020-02144-0.
PubMed 33482865Mohammad HR, Hamilton TW, Strickland L, Trivella M, Murray D, Pandit H. Perioperative adjuvant corticosteroids for postoperative analgesia in knee arthroplasty. Acta Orthop. 2018 Feb;89(1):71-76. doi: 10.1080/17453674.2017.1391409. Epub 2017 Oct 25.
PubMed 29065753Yue C, Wei R, Liu Y. Perioperative systemic steroid for rapid recovery in total knee and hip arthroplasty: a systematic review and meta-analysis of randomized trials. J Orthop Surg Res. 2017 Jun 27;12(1):100. doi: 10.1186/s13018-017-0601-4.
PubMed 28655354
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylprednisolone Taper to Treat Delayed Post-Operative Recovery After Total Knee Arthroplasty: a Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05113901
- Acronym / sponsor ID
- 21080501
- Conditions
- Total Knee Arthroplasty
- Keywords
- Methylprednisolone, Delayed recover, range of motion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extremely low participation, decided to focus on similar study instead
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone taper | Active comparator | Drug: Methylprednisolone21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM <90° at 8 weeks |
| Placebo taper | Placebo comparator | Drug: Placebo21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM <90° at 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM <90° at 8 weeks | Drug | Methylprednisolone taper |
| Placebo21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM <90° at 8 weeks | Drug | Placebo taper |
Primary outcome
Range of Motion in Degrees at Pre and Post Treatment
Time frame: Baseline, Week 6 Following 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.
17 secondary outcomes
Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)
Time frame: 6 weeks post treatment
Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores
Time frame: pre treatment
Patient Reported Outcome Measures: Post Treatment Pain Scores
Time frame: 3 weeks post treatment
Patient Reported Outcome Measures: Post Treatment Pain Scores
Time frame: 6 weeks post treatment
Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores
Time frame: Days 1 through 6 following treatment
Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
Time frame: pre treatment
Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
Time frame: 6 weeks after treatment
Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
Time frame: pre treatment
Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
Time frame: 6 weeks after treatment
Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
Time frame: pre treatment
Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
Time frame: 6 weeks after treatment
Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
Time frame: pre treatment
Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment
Time frame: 6 weeks after treatment
Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
Time frame: pre treatment
Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
Time frame: 6 weeks after treatment
Number of Participants With Complications Following Treatment
Time frame: within 90 days after initial total knee arthroplasty
Adverse Events or Outcomes Outside of Manipulations Under Anesthesia
Time frame: within 90 days after initial total knee arthroplasty
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28801208Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.
- Background: PubMed 26333733Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA, Jiranek WA, Berry DJ. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am. 2015 Sep 2;97(17):1386-97. doi: 10.2106/JBJS.N.01141.
- Background: PubMed 30180053Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.
- Background: PubMed 28209371Bayliss LE, Culliford D, Monk AP, Glyn-Jones S, Prieto-Alhambra D, Judge A, Cooper C, Carr AJ, Arden NK, Beard DJ, Price AJ. The effect of patient age at intervention on risk of implant revision after total replacement of the hip or knee: a population-based cohort study. Lancet. 2017 Apr 8;389(10077):1424-1430. doi: 10.1016/S0140-6736(17)30059-4. Epub 2017 Feb 14.
- Background: PubMed 30782340Evans JT, Evans JP, Walker RW, Blom AW, Whitehouse MR, Sayers A. How long does a hip replacement last? A systematic review and meta-analysis of case series and national registry reports with more than 15 years of follow-up. Lancet. 2019 Feb 16;393(10172):647-654. doi: 10.1016/S0140-6736(18)31665-9. Epub 2019 Feb 14.
- Background: PubMed 8158821Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994 May 4;271(17):1349-57.
- Background: PubMed 15118039Ethgen O, Bruyere O, Richy F, Dardennes C, Reginster JY. Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. J Bone Joint Surg Am. 2004 May;86(5):963-74. doi: 10.2106/00004623-200405000-00012.
- Background: PubMed 34182793Heath EL, Ackerman IN, Cashman K, Lorimer M, Graves SE, Harris IA. Patient-reported outcomes after hip and knee arthroplasty : results from a large national registry. Bone Jt Open. 2021 Jun;2(6):422-432. doi: 10.1302/2633-1462.26.BJO-2021-0053.R1.
- Background: PubMed 25609443Shan L, Shan B, Suzuki A, Nouh F, Saxena A. Intermediate and long-term quality of life after total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Am. 2015 Jan 21;97(2):156-68. doi: 10.2106/JBJS.M.00372.
- Background: PubMed 16085610Kane RL, Saleh KJ, Wilt TJ, Bershadsky B. The functional outcomes of total knee arthroplasty. J Bone Joint Surg Am. 2005 Aug;87(8):1719-24. doi: 10.2106/JBJS.D.02714.
- Background: PubMed 29656980Kagan R, Anderson MB, Christensen JC, Peters CL, Gililland JM, Pelt CE. The Recovery Curve for the Patient-Reported Outcomes Measurement Information System Patient-Reported Physical Function and Pain Interference Computerized Adaptive Tests After Primary Total Knee Arthroplasty. J Arthroplasty. 2018 Aug;33(8):2471-2474. doi: 10.1016/j.arth.2018.03.020. Epub 2018 Mar 17.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone in people with Total Knee Arthroplasty, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion in Degrees at Pre and Post Treatment (time frame: Baseline, Week 6 Following Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05113901, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.