Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis (Pain+Stiffness)

December 23, 2024 updated by: Hospital for Special Surgery, New York
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Total Knee Arthroplasty
Patients will undergo total unilateral knee arthroplasty for osteoarthritis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months after date of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients Who Experienced Postoperative Joint Stiffness
Time Frame: 6 weeks after date of surgery
The number of patients that experienced postoperative joint stiffness, defined as ≤95 degrees range of motion.
6 weeks after date of surgery
Postoperative Knee Range of Motion
Time Frame: 6 weeks after date of surgery
Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees.
6 weeks after date of surgery
NRS Pain at Rest on POD1
Time Frame: 1 day after surgery
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.
1 day after surgery
NRS Pain With Movement on POD1
Time Frame: 1 day after surgery
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.
1 day after surgery
Worst NRS Pain on POD1
Time Frame: 1 day after surgery
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.
1 day after surgery
Least NRS Pain on POD1
Time Frame: 1 day after surgery
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.
1 day after surgery
NRS Pain at Rest on POD2
Time Frame: 2 days after surgery
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.
2 days after surgery
NRS Pain With Movement on POD2
Time Frame: 2 days after surgery
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.
2 days after surgery
Worst NRS Pain on POD2
Time Frame: 2 days after surgery
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.
2 days after surgery
Least NRS Pain on POD2
Time Frame: 2 days after surgery
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.
2 days after surgery
NRS Pain at Rest 4 Weeks After Surgery
Time Frame: 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.
4 weeks after surgery
NRS Pain With Movement 4 Weeks After Surgery
Time Frame: 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.
4 weeks after surgery
Worst NRS Pain 4 Weeks After Surgery
Time Frame: 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.
4 weeks after surgery
Least NRS Pain 4 Weeks After Surgery
Time Frame: 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.
4 weeks after surgery
NRS Pain at Rest 3 Months After Surgery
Time Frame: 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.
3 months after surgery
NRS Pain With Movement 3 Months After Surgery
Time Frame: 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.
3 months after surgery
Worst NRS Pain 3 Months After Surgery
Time Frame: 3 months after date of 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.
3 months after date of surgery
Least NRS Pain 3 Months After Surgery
Time Frame: 3 months after date of 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.
3 months after date of surgery
NRS Pain at Rest 6 Months After Surgery
Time Frame: 6 months after date of 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.
6 months after date of surgery
Least NRS Pain 6 Months After Surgery
Time Frame: 6 months after date of 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.
6 months after date of surgery
Worst NRS Pain 6 Months After Surgery
Time Frame: 6 months after date of 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.
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

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.
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

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.
4 weeks, 3 months, and 6 months after date of surgery
Types of Preoperative Medications
Time Frame: Before surgery
Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.
Before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital for Special Surgery, New York

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meghan Kirksey, MD, PhD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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