Trial Outcomes & Findings for Risk Factors and Mechanisms for Persistent Postsurgical Pain After Total Knee Replacement (NCT NCT01320150)

Results Overview

PPP for this study will be defined as "pain in the operated knee at six months after Total Knee Replacement surgery, with other causes of pain excluded, and a reported intensity on 0-10 Numerical Response Scale (NRS) of ≥4 where higher pain scores indicate higher levels of pain. NRS scores range from 0 {No Pain} to 10 {Worst Imaginable Pain}.

Recruitment status

COMPLETED

Target enrollment

311 participants

Primary outcome timeframe

6 months postoperatively

Results posted on

2021-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants Study Subjects with and without Persistent Post-operative Pain (PPP) at followup
Overall Study STARTED	311
Overall Study PPP	34
Overall Study Non-PPP	211
Overall Study COMPLETED	245
Overall Study NOT COMPLETED	66

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Study Subjects with and without Persistent Post-operative Pain (PPP) at followup
Overall Study Protocol Violation	15
Overall Study Withdrawal by Subject	5
Overall Study Death	2
Overall Study Lost to Follow-up	44

Baseline Characteristics

Risk Factors and Mechanisms for Persistent Postsurgical Pain After Total Knee Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non PPP n=211 Participants Those without Persistent Post-surgical Pain (PPP)	Persistent Post Surgical Pain (PPP) n=34 Participants Those with Persistent Post-surgical Pain (PPP)	Total n=245 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	64 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	133 Participants n=5 Participants	27 Participants n=7 Participants	160 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	7 Participants n=7 Participants	85 Participants n=5 Participants
Race/Ethnicity, Customized White	159 Participants n=5 Participants	20 Participants n=7 Participants	179 Participants n=5 Participants
Race/Ethnicity, Customized African American	52 Participants n=5 Participants	14 Participants n=7 Participants	66 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months postoperatively

PPP for this study will be defined as "pain in the operated knee at six months after Total Knee Replacement surgery, with other causes of pain excluded, and a reported intensity on 0-10 Numerical Response Scale (NRS) of ≥4 where higher pain scores indicate higher levels of pain. NRS scores range from 0 {No Pain} to 10 {Worst Imaginable Pain}.

Outcome measures

Outcome measures
Measure	PPP and Non-PPP n=245 Participants Study Subjects with PPP and without PPP at followup
Number of Subjects With Post-Operative Persistent Pain (PPP) non PPP	211 Participants
Number of Subjects With Post-Operative Persistent Pain (PPP) PPP	34 Participants

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert McCarthy

Rush University Medical Center

Phone: (312) 563-0448

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place