Trial Outcomes & Findings for Medrol Dosepak Taper for Delayed Post-op Recovery After TKA (NCT NCT05113901)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

Baseline, Week 6 Following Treatment

Results posted on

2023-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Methylprednisolone Taper 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Overall Study STARTED	4	0
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Medrol Dosepak Taper for Delayed Post-op Recovery After TKA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methylprednisolone Taper n=4 Participants 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	63.31 years n=5 Participants	—	63.31 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	—	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6 Following Treatment

Population: \*\*Please note, this study was terminated early, only enrolling 4 patients, none were randomized to the placebo group.

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.

Outcome measures

Outcome measures
Measure	Methylprednisolone Taper n=4 Participants 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Range of Motion in Degrees at Pre and Post Treatment Pre treatment	82.5 Range of Motion in Degrees Interval 50.0 to 95.0	—
Range of Motion in Degrees at Pre and Post Treatment Post treatment	112 Range of Motion in Degrees Interval 105.0 to 120.0	—

SECONDARY outcome

Timeframe: 6 weeks post treatment

Population: This study was terminated early, only 1 of the 4 enrolled subjects reached the 6 week mark.

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

Outcome measures

Outcome measures
Measure	Methylprednisolone Taper n=1 Participants 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)	1.93 score on a scale	—

SECONDARY outcome

Timeframe: pre treatment

Population: \*\*Please note, this study was terminated early, only enrolling 4 patients, none were randomized to the placebo group.

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.

Outcome measures

Outcome measures
Measure	Methylprednisolone Taper n=4 Participants 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores	66.25 score on a scale Interval 55.0 to 90.0	—

SECONDARY outcome

Timeframe: 3 weeks post treatment

Population: \*\*Please note, this study was terminated early, only enrolling 4 patients, none were randomized to the placebo group.

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.

Outcome measures

Outcome measures
Measure	Methylprednisolone Taper n=3 Participants 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Patient Reported Outcome Measures: Post Treatment Pain Scores	68.33 score on a scale Interval 60.0 to 85.0	—

SECONDARY outcome

Timeframe: 6 weeks post treatment

Population: \*\*Please note, this study was terminated early, only enrolling 4 patients, none were randomized to the placebo group.

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.

Outcome measures

Outcome measures
Measure	Methylprednisolone Taper n=3 Participants 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Patient Reported Outcome Measures: Post Treatment Pain Scores	78.75 score on a scale Interval 55.0 to 90.0	—

SECONDARY outcome

Timeframe: Days 1 through 6 following treatment

Population: \*\*Please note, this study was terminated early, only enrolling 4 patients, none were randomized to the placebo group.

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.

Outcome measures

Outcome measures
Measure	Methylprednisolone Taper n=4 Participants 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores Day 1	2.33 score on a scale Interval 0.0 to 4.0	—
Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores Day 2	3 score on a scale Interval 0.0 to 8.0	—
Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores Day 3	1.33 score on a scale Interval 0.0 to 3.0	—
Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores Day 4	1.33 score on a scale Interval 0.0 to 3.0	—
Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores Day 5	1.67 score on a scale Interval 1.0 to 3.0	—
Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores Day 6	2.3 score on a scale Interval 1.0 to 3.0	—

SECONDARY outcome

Timeframe: pre treatment

Population: Please note, the study was terminated early and only 4 patients were enrolled. Of the 4 enrolled, none were randomized to the placebo group.

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.

Outcome measures

Outcome measures
Measure	Methylprednisolone Taper n=4 Participants 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment	50.04 score on a scale Interval 28.0 to 68.28	—

SECONDARY outcome

Timeframe: 6 weeks after treatment

Population: Please note, this study was terminated early where we only enrolled 4 subjects. Of the 4, none were randomized to the placebo group.

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.

Outcome measures

Outcome measures
Measure	Methylprednisolone Taper n=4 Participants 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment	72.12 score on a scale Interval 61.58 to 91.98	—

SECONDARY outcome

Timeframe: pre treatment

Population: Please note, this study was terminated early where we only enrolled 4 subjects. Of the 4, none were randomized to the placebo group.

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.

Outcome measures

Outcome measures
Measure	Methylprednisolone Taper n=4 Participants 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks Methylprednisolone: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks	Placebo Taper 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks Placebo: 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment	38.73 score on a scale Interval 30.19 to 44.62	—

SECONDARY outcome

Timeframe: 6 weeks after treatment

Population: This study was terminated early after only 4 subjects were enrolled. None of these patients were randomized to the placebo group.

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.