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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Arthroplasty | Procedure | Patients will undergo total unilateral knee arthroplasty for osteoarthritis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Who Experienced Postoperative Joint Stiffness | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.
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| Name | Affiliation | Role |
|---|---|---|
| Meghan Kirksey, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34921052 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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, and questionnaires will be administered to assess pain and stiffness. Total Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Knee Arthroplasty Patients (Stiff) | Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness. Total Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis. Stiffness was defined as ≤ 95° ROM measured with a goniometer at 6 weeks (± 2 weeks). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Some patients lost to follow up | Posted | Count of Participants | Participants | 6 months after date of surgery |
|
up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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, and questionnaires will be administered to assess pain and stiffness. Total Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meghan Kirksey | Hospital for Special Surgery, Anesthesiology | 2126061036 | KirkseyM@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2019 | Apr 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Whole blood, serum, and joint fluid aspirate samples will be collected and stored for analysis.
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications. | Before surgery |
| BG001 | Total Knee Arthroplasty Patients (Non-Stiff) | Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness. Total Knee Arthroplasty: Patients will undergo total unilateral knee arthroplasty for osteoarthritis. Stiffness was defined as ≤ 95° ROM measured with a goniometer at 6 weeks (± 2 weeks). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Patients Who Experienced Postoperative Joint Stiffness | The number of patients that experienced postoperative joint stiffness, defined as ≤95 degrees range of motion. | Posted | Count of Participants | Participants | 6 weeks after date of surgery |
|
|
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| Secondary | Postoperative Knee Range of Motion | Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees. | some patients did not answer the questionnaire | Posted | Mean | Standard Deviation | degrees | 6 weeks after date of surgery |
|
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|
| Secondary | 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. | some lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 1 day after surgery |
|
|
|
| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | units on a scale | 1 day after surgery |
|
|
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| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 1 day after surgery |
|
|
|
| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | units on a scale | 1 day after surgery |
|
|
|
| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 2 days after surgery |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 days after surgery |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 days after surgery |
|
|
|
| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 2 days after surgery |
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|
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| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after surgery |
|
|
|
| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after surgery |
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|
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| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after surgery |
|
|
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| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after surgery |
|
|
|
| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 3 months after surgery |
|
|
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| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 3 months after surgery |
|
|
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| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 3 months after date of surgery |
|
|
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| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 3 months after date of surgery |
|
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| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months after date of surgery |
|
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| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months after date of surgery |
|
|
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| Secondary | 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. | Some patients lost to follow up or did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months after date of surgery |
|
|
|
| Secondary | 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. | This outcome was measured at three different timepoints (4 weeks, 3 months, and 6 months). Some participants could not be reached for follow-up at certain timepoints, therefore the number of patients analyzed for each timepoint differs. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks, 3 months, and 6 months after date of surgery |
|
|
|
| Secondary | 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. | This outcome was measured at three different timepoints (4 weeks, 3 months, and 6 months). Some participants could not be reached for follow-up at certain timepoints, therefore the number of patients analyzed for each timepoint differs. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks, 3 months, and 6 months after date of surgery |
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| Secondary | 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. | some patients did not answer the questionnaire | Posted | Count of Participants | Participants | Before surgery |
|
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|
| 0 |
| 162 |
| 0 |
| 162 |
| 0 |
| 162 |
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| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| KOOS Quality of Life 4 weeks |
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| KOOS Symptoms 3 month |
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| KOOS Quality of Life 3 month |
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| KOOS Symptoms 6 month |
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| KOOS Quality of Life 6 month |
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| 3 months |
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| 6 months |
|
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| used anticonvulsants |
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| used selective serotonin reuptake inhibitors |
|
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| used tricyclic antidepressants |
|
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| used serotonin-norepinephrine reuptake inhibitors |
|
|