Persistent Postsurgical PainPPP-TKANCT01320150
Risk Factors and Mechanisms for Persistent Postsurgical Pain After Total Knee Replacement
An observational study of Persistent Postsurgical Pain, run by Rush University Medical Center at 1 site in United States.
Trial summary
Osteoarthritis (OA) is the single most common cause of disability in mid and late life. About 27 million people in the United States suffer from this incurable process and 10 million have OA of the knee. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Persistent Postsurgical Pain
- How many people
- 311 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Apr 2018
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Osteoarthritis patients at the RUSH university medical center undergoing primary, unilateral TKR
Who may be able to join
- undergoing standard tricompartmental TKR;
- 18 to 85 yrs of age;
- patient has a diagnosis of osteoarthritis
- knee to be replaced is the primary source of patient's pain;
- patient agrees to preoperative and follow-up visits and to comply with the assessment tests;
- patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.
Who cannot join
- chronic opioid use ≥ 10 mg/day of morphine equivalents within one wk prior to the surgery, and duration of use > 4 wks;
- history of opioid abuse;
- inability to understand and communicate with the investigators to complete the study related questionnaires
- patient currently enrolled in another study;
- patient is planning to undergo another elective joint replacement procedure during the 6-mo period of participation;
- any co-morbidity which results in severe systemic disease limiting function {as defined by the American Society of Anesthesiology (ASA) physical status classification > 3}
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Osteoarthritis (OA) is the single most common cause of disability in mid and late life. About 27 million people in the United States suffer from this incurable process and 10 million have OA of the knee. Total knee replacement (TKR) is a reliable treatment option for patients disabled by knee OA who have failed non-operative treatment; 58% of these surgeries are performed on patients 65 years or older. Despite the overall success of TKR in most cases, persistent postsurgical pain (PPP) of the operated knee remains a common and often difficult to treat postoperative outcome affecting 13-20% of all patients at 6 months post-TKR, which amounts to 65,000-100,000 patients/year in the USA. Important secondary outcomes of PPP are restricted physical mobility and poor quality of life, especially in older patients.
Recent findings spanning the pre-, intra- and postoperative periods suggest that the development of PPP after TKR is a multi-factorial process, comprised of both neurophysiologic and psychosocial factors. Likely determinates include preoperative thermal pain sensitivity, anxiety, pain catastrophizing; and postoperative area of secondary mechanical hyperalgesia or hypoalgesia (numbness). There is already agreement that the intensity of early (acute) postoperative pain is one of the factors predicting PPP. To date, most studies have examined the role of risk factors in isolation and/or within a single domain, and no prospective study has comprehensively evaluated the interaction of neurophysiologic and psychosocial variables in the evolution of PPP following TKR. The lack of information regarding how neurophysiologic pathways and patient cognitive/affective states interact over time following otherwise successful TKR has greatly undermined the understanding of PPP after TKR.
The proposed project is a single-site, prospective study of 300 OA patients aged 18-85 yrs undergoing primary TKR. The study is designed to identify factors from the pre-, intra- and postoperative phases of TKR that contribute to PPP at 6 months. Specific risk factors were selected because they are potentially modifiable, and therefore may be amenable to intervention. Patients will be assessed from pre-surgery to 6 months post surgery. The proposed multi-factorial and prospective approach to investigating risk factors is a vital next step towards understanding the complex phenomenon of PPP.
Read the detailed description
Overall Strategy: The primary aim of this application is to investigate relationships of risk factors to the development of persistent postoperative pain (PPP) at 6 mo following TKR, through independently predictive and mediated models.
These risk factors are preoperative thermal pain sensitivity, pain anxiety and catastrophizing; postoperative area of secondary mechanical hyperalgesia or hypoalgesia (numbness) and pain intensity. PPP for this study will be defined as "pain in the operated knee at six months after TKR, with other causes of pain excluded and reported intensity on 0-10 Numerical Response Scale (NRS) scale of ≥4". The study will also evaluate the relationship of PPP incidence with the severity of functional impairment. This is a single-site prospective clinical investigation of 300 consented OA patients undergoing primary, unilateral TKR.
- Conditions
- Persistent Postsurgical Pain
- Keywords
- persistent postsurgical pain (PPP)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PPP and Non-PPP | Study Subjects with PPP and without PPP at followup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Post-Operative Persistent Pain (PPP)
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}.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2017
- Study completionApr 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Postsurgical PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Asokumar Buvanendran, Rush University Medical Center
- Investigators
- Asokumar Buvanendran, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320150
- Sponsor's protocol ID
- WS735224
- Acronym
- PPP-TKA
- Status last verified
- Aug 2021
- First submitted
- 18 Mar 2011
- Last updated
- 23 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Buvanendran A, Della Valle CJ, Kroin JS, Shah M, Moric M, Tuman KJ, McCarthy RJ. Acute postoperative pain is an independent predictor of chronic postsurgical pain following total knee arthroplasty at 6 months: a prospective cohort study. Reg Anesth Pain Med. 2019 Mar;44(3):e100036. doi: 10.1136/rapm-2018-100036. Epub 2019 Feb 15.
PubMed 30770420
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Mechanisms for Persistent Postsurgical Pain After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01320150
- Acronym / sponsor ID
- PPP-TKA / WS735224
- Conditions
- Persistent Postsurgical Pain
- Keywords
- persistent postsurgical pain (PPP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2011
- Primary completion
- Aug 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Posted 3 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is the single most common cause of disability in mid and late life. About 27 million people in the United States suffer from this incurable process and 10 million have OA of the knee. Total knee replacement (TKR) is a reliable treatment option for patients disabled by knee OA who have failed non-operative treatment; 58% of these surgeries are performed on patients 65 years or older. Despite the overall success of TKR in most cases, persistent postsurgical pain (PPP) of the operated knee remains a common and often difficult to treat postoperative outcome affecting 13-20% of all patients at 6 months post-TKR, which amounts to 65,000-100,000 patients/year in the USA. Important secondary outcomes of PPP are restricted physical mobility and poor quality of life, especially in older patients.
Recent findings spanning the pre-, intra- and postoperative periods suggest that the development of PPP after TKR is a multi-factorial process, comprised of both neurophysiologic and psychosocial factors. Likely determinates include preoperative thermal pain sensitivity, anxiety, pain catastrophizing; and postoperative area of secondary mechanical hyperalgesia or hypoalgesia (numbness). There is already agreement that the intensity of early (acute) postoperative pain is one of the factors predicting PPP. To date, most studies have examined the role of risk factors in isolation and/or within a single domain, and no prospective study has comprehensively evaluated the interaction of neurophysiologic and psychosocial variables in the evolution of PPP following TKR. The lack of information regarding how neurophysiologic pathways and patient cognitive/affective states interact over time following otherwise successful TKR has greatly undermined the understanding of PPP after TKR.
The proposed project is a single-site, prospective study of 300 OA patients aged 18-85 yrs undergoing primary TKR. The study is designed to identify factors from the pre-, intra- and postoperative phases of TKR that contribute to PPP at 6 months. Specific risk factors were selected because they are potentially modifiable, and therefore may be amenable to intervention. Patients will be assessed from pre-surgery to 6 months post surgery. The proposed multi-factorial and prospective approach to investigating risk factors is a vital next step towards understanding the complex phenomenon of PPP.
Detailed description
Overall Strategy: The primary aim of this application is to investigate relationships of risk factors to the development of persistent postoperative pain (PPP) at 6 mo following TKR, through independently predictive and mediated models.
These risk factors are preoperative thermal pain sensitivity, pain anxiety and catastrophizing; postoperative area of secondary mechanical hyperalgesia or hypoalgesia (numbness) and pain intensity. PPP for this study will be defined as "pain in the operated knee at six months after TKR, with other causes of pain excluded and reported intensity on 0-10 Numerical Response Scale (NRS) scale of ≥4". The study will also evaluate the relationship of PPP incidence with the severity of functional impairment. This is a single-site prospective clinical investigation of 300 consented OA patients undergoing primary, unilateral TKR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPP and Non-PPP | – | –Study Subjects with PPP and without PPP at followup |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Osteoarthritis patients at the RUSH university medical center undergoing primary, unilateral TKR
Key inclusion criteria (6 listed)
- undergoing standard tricompartmental TKR;
- 18 to 85 yrs of age;
- patient has a diagnosis of osteoarthritis
- knee to be replaced is the primary source of patient's pain;
- patient agrees to preoperative and follow-up visits and to comply with the assessment tests;
Key exclusion criteria (6 listed)
- chronic opioid use ≥ 10 mg/day of morphine equivalents within one wk prior to the surgery, and duration of use > 4 wks;
- history of opioid abuse;
- inability to understand and communicate with the investigators to complete the study related questionnaires
- patient currently enrolled in another study;
- patient is planning to undergo another elective joint replacement procedure during the 6-mo period of participation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Subjects With Post-Operative Persistent Pain (PPP)
Time frame: 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}.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30770420Buvanendran A, Della Valle CJ, Kroin JS, Shah M, Moric M, Tuman KJ, McCarthy RJ. Acute postoperative pain is an independent predictor of chronic postsurgical pain following total knee arthroplasty at 6 months: a prospective cohort study. Reg Anesth Pain Med. 2019 Mar;44(3):e100036. doi: 10.1136/rapm-2018-100036. Epub 2019 Feb 15.
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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.
Asokumar Buvanendran, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Postsurgical Pain, 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Sep 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2019). 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?
Number of Subjects With Post-Operative Persistent Pain (PPP) (time frame: 6 months postoperatively). 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 NCT01320150, which also lists 1 linked publication.
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 Sep 2021.