PainNCT02626533
Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis
An observational study of Pain and Joint Stiffness, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Joint Stiffness
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 28 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.
Who may be able to join
- Elective primary unilateral total knee arthroplasty
- Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
- Patients of surgeons who have agreed to participate in the study
- Age > 18 years
- American Society of Anesthesiologists (ASA) Physical Status 1-3
- Regional anesthesia
- Epidural patient-controlled analgesia (PCA) for postoperative pain
- Adductor canal block for postoperative pain
Who cannot join
- Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
- Use of general anesthesia
- History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids
- Preoperative oral steroid use in the past 6 months
- Intra-articular steroid injection within one month of scheduled surgery in affected joint
- Non-English speakers
Show all 12Show fewer
- Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
- Peri-articular injections or infusions for postoperative pain
- Diagnosis of crystalline arthropathy
- Diagnosis of osteonecrosis
- Active infection or use of antibiotics
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. There is growing evidence that inflammation as well as other medical and psychological factors may be associated with osteoarthritis severity, progression, and associated pain severity. This study aims to identify clinical, biological, and psychological factors that contribute to and predict the development of these complications. Identification of such factors may allow us to target preventative measures to the patients at highest risk of persistent postoperative pain and joint stiffness.
- Conditions
- Pain, Joint Stiffness
- Being tested
- Total Knee Arthroplasty
- Keywords
- Cytokines
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Patients will undergo total unilateral knee arthroplasty for osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty patients | Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study.
Blood and joint fluid samples will be obtained from patients. Pain type and severity will be assessed at baseline (enrollment), 4 weeks, 3 months, and 6 months postoperatively. Receives: Procedure: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS)
Defined as numeric rating scale (NRS) pain score ≥4 with activity in the operated joint. A lower score is a better outcome. 0 is no pain, and 10 is worst pain imaginable.
Measured: 6 months after date of surgery
Secondary outcomes (24)
Patients Who Experienced Postoperative Joint Stiffness
The number of patients that experienced postoperative joint stiffness, defined as ≤95 degrees range of motion.
Measured: 6 weeks after date of surgery
Postoperative Knee Range of Motion
Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees.
Measured: 6 weeks after date of surgery
NRS Pain at Rest on POD1
NRS pain at rest on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 1 day after surgery
NRS Pain With Movement on POD1
NRS pain with movement on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 1 day after surgery
Worst NRS Pain on POD1
Worst NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 1 day after surgery
Least NRS Pain on POD1
Least numerical rating scale (NRS) pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 1 day after surgery
NRS Pain at Rest on POD2
Numerical rating scale (NRS) pain at rest on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 2 days after surgery
NRS Pain With Movement on POD2
Numerical rating scale (NRS) pain with movement on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 2 days after surgery
Worst NRS Pain on POD2
Worst numerical rating scale (NRS) pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 2 days after surgery
Least NRS Pain on POD2
Least numerical rating scale (NRS) pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 2 days after surgery
NRS Pain at Rest 4 Weeks After Surgery
Numerical rating scale (NRS) pain at rest on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 4 weeks after surgery
NRS Pain With Movement 4 Weeks After Surgery
Numerical rating scale (NRS) pain with movement on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 4 weeks after surgery
Worst NRS Pain 4 Weeks After Surgery
Worst numerical rating scale (NRS) pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 4 weeks after surgery
Least NRS Pain 4 Weeks After Surgery
Least numerical rating scale (NRS) pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 4 weeks after surgery
NRS Pain at Rest 3 Months After Surgery
Numerical rating scale (NRS) pain at rest 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Measured: 3 months after surgery
NRS Pain With Movement 3 Months After Surgery
Numerical rating scale (NRS) pain with movement 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
The average NRS pain for all participants who completed the survey at 3 months is reported.
Measured: 3 months after surgery
Worst NRS Pain 3 Months After Surgery
Worst numerical rating scale (NRS) pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
The average worst NRS pain for all participants who completed the survey at 3 months is reported.
Measured: 3 months after date of surgery
Least NRS Pain 3 Months After Surgery
Least numerical pain rating (NRS) pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
The average least NRS pain for all participants who completed the survey at 3 months is reported.
Measured: 3 months after date of surgery
NRS Pain at Rest 6 Months After Surgery
NRS pain at rest 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
The average NRS pain at rest for all participants who completed the survey at 6 months is reported.
Measured: 6 months after date of surgery
Least NRS Pain 6 Months After Surgery
Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
The average least NRS pain for all participants who completed the survey at 6 months is reported.
Measured: 6 months after date of surgery
Worst NRS Pain 6 Months After Surgery
Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
The average worst NRS pain for all participants who completed the survey at 6 months is reported.
Measured: 6 months after date of surgery
Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A higher score is a better outcome.
The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Although collected at different timepoints, the average score for each participant is calculated and then the average score for all patients is reported.
Measured: 4 weeks, 3 months, and 6 months after date of surgery
Postoperative painDETECT Scores
PainDETECT is a 9-item self-report screening questionnaire developed to detect NeP in conditions like chronic low back pain. PD-Q measures 7 aspects of the quality of the pain experienced, the chronological pattern (time course), and whether or not the pain radiates.
It is scored from 0 to 38, with total scores of <12 considered = nociceptive pain, 13-18 = possible NeP, and >19 = >90% likelihood of NeP. A lower score is a better outcome.
Although measured at multiple time points, the average score for each participant is analyzed, and then the average scores for all participants is calculated and reported.
Measured: 4 weeks, 3 months, and 6 months after date of surgery
Types of Preoperative Medications
Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion28 Aug 2017
- Study completion28 Feb 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 PainStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan Kirksey, MD, PhD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626533
- Sponsor's protocol ID
- 2015-361
- Status last verified
- Feb 2024
- First submitted
- 8 Dec 2015
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sideris A, Malahias MA, Birch G, Zhong H, Rotundo V, Like BJ, Otero M, Sculco PK, Kirksey M. Identification of biological risk factors for persistent postoperative pain after total knee arthroplasty. Reg Anesth Pain Med. 2022 Mar;47(3):161-166. doi: 10.1136/rapm-2021-102953. Epub 2021 Dec 17.
PubMed 34921052
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis
- ClinicalTrials.gov ID
- NCT02626533
- Acronym / sponsor ID
- 2015-361
- Conditions
- Pain, Joint Stiffness
- Keywords
- Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Posted 19 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. There is growing evidence that inflammation as well as other medical and psychological factors may be associated with osteoarthritis severity, progression, and associated pain severity. This study aims to identify clinical, biological, and psychological factors that contribute to and predict the development of these complications. Identification of such factors may allow us to target preventative measures to the patients at highest risk of persistent postoperative pain and joint stiffness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty patients | – | Procedure: Total Knee ArthroplastyPatients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients. Pain type and severity will be assessed at baseline (enrollment), 4 weeks, 3 months, and 6 months postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.
Key inclusion criteria (8 listed)
- Elective primary unilateral total knee arthroplasty
- Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
- Patients of surgeons who have agreed to participate in the study
- Age > 18 years
- American Society of Anesthesiologists (ASA) Physical Status 1-3
Key exclusion criteria (12 listed)
- Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
- Use of general anesthesia
- History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids
- Preoperative oral steroid use in the past 6 months
- Intra-articular steroid injection within one month of scheduled surgery in affected joint
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 |
|---|---|---|
| Total Knee ArthroplastyPatients will undergo total unilateral knee arthroplasty for osteoarthritis. | Procedure or surgery | Total knee arthroplasty patients |
Primary outcome
Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS)
Time frame: 6 months after date of surgery
Defined as numeric rating scale (NRS) pain score ≥4 with activity in the operated joint. A lower score is a better outcome. 0 is no pain, and 10 is worst pain imaginable.
24 secondary outcomes
Patients Who Experienced Postoperative Joint Stiffness
Time frame: 6 weeks after date of surgery
Postoperative Knee Range of Motion
Time frame: 6 weeks after date of surgery
NRS Pain at Rest on POD1
Time frame: 1 day after surgery
NRS Pain With Movement on POD1
Time frame: 1 day after surgery
Worst NRS Pain on POD1
Time frame: 1 day after surgery
Least NRS Pain on POD1
Time frame: 1 day after surgery
NRS Pain at Rest on POD2
Time frame: 2 days after surgery
NRS Pain With Movement on POD2
Time frame: 2 days after surgery
Worst NRS Pain on POD2
Time frame: 2 days after surgery
Least NRS Pain on POD2
Time frame: 2 days after surgery
NRS Pain at Rest 4 Weeks After Surgery
Time frame: 4 weeks after surgery
NRS Pain With Movement 4 Weeks After Surgery
Time frame: 4 weeks after surgery
Worst NRS Pain 4 Weeks After Surgery
Time frame: 4 weeks after surgery
Least NRS Pain 4 Weeks After Surgery
Time frame: 4 weeks after surgery
NRS Pain at Rest 3 Months After Surgery
Time frame: 3 months after surgery
NRS Pain With Movement 3 Months After Surgery
Time frame: 3 months after surgery
Worst NRS Pain 3 Months After Surgery
Time frame: 3 months after date of surgery
Least NRS Pain 3 Months After Surgery
Time frame: 3 months after date of surgery
NRS Pain at Rest 6 Months After Surgery
Time frame: 6 months after date of surgery
Least NRS Pain 6 Months After Surgery
Time frame: 6 months after date of surgery
Worst NRS Pain 6 Months After Surgery
Time frame: 6 months after date of surgery
Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores
Time frame: 4 weeks, 3 months, and 6 months after date of surgery
Postoperative painDETECT Scores
Time frame: 4 weeks, 3 months, and 6 months after date of surgery
Types of Preoperative Medications
Time frame: Before surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34921052Sideris A, Malahias MA, Birch G, Zhong H, Rotundo V, Like BJ, Otero M, Sculco PK, Kirksey M. Identification of biological risk factors for persistent postoperative pain after total knee arthroplasty. Reg Anesth Pain Med. 2022 Mar;47(3):161-166. doi: 10.1136/rapm-2021-102953. Epub 2021 Dec 17.
- 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.
Meghan Kirksey, MD, PhD principal investigator
Hospital for Special Surgery, New York
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 Pain and Joint Stiffness, run by Hospital for Special Surgery, New York 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 12 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 27 Dec 2024. 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 19 Jul 2024). 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?
Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS) (time frame: 6 months after date of surgery). 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 NCT02626533, 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 27 Dec 2024.