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

NCT02626533 | Completed Results

• 1 other identifier: 2015-361
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Cytokines

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after date of surgery

Secondary Outcomes (24)

• Patients Who Experienced Postoperative Joint Stiffness

  6 weeks after date of surgery

• Postoperative Knee Range of Motion

  6 weeks after date of surgery

• NRS Pain at Rest on POD1

  1 day after surgery

• NRS Pain With Movement on POD1

  1 day after surgery

• Worst NRS Pain on POD1

  1 day after surgery

Study Arms (1)

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

Interventions

Total Knee Arthroplasty PROCEDURE

Patients will undergo total unilateral knee arthroplasty for osteoarthritis.

Total knee arthroplasty patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 34921052 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, and joint fluid aspirate samples will be collected and stored for analysis.

MeSH Terms

Conditions

Pain

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Dr. Meghan Kirksey
• Organization: Hospital for Special Surgery, Anesthesiology

KirkseyM@hss.edu

2126061036

Study Officials

• Meghan Kirksey, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 10, 2015
• Study Start: December 1, 2015
• Primary Completion: August 28, 2017
• Study Completion: February 28, 2018
• Last Updated: December 27, 2024
• Results First Posted: July 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)