Joint Stiffness, Pain
Conditions
Keywords
Cytokines
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.
Interventions
PROCEDURETotal Knee Arthroplasty
Patients will undergo total unilateral knee arthroplasty for osteoarthritis.
Sponsors
Hospital for Special Surgery, New York
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain With Movement on POD2 | 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. |
| Worst NRS Pain on POD2 | 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. |
| Least NRS Pain on POD2 | 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. |
| Patients Who Experienced Postoperative Joint Stiffness | 6 weeks after date of surgery | The number of patients that experienced postoperative joint stiffness, defined as ≤95 degrees range of motion. |
| Postoperative Knee Range of Motion | 6 weeks after date of surgery | Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees. |
| NRS Pain at Rest on POD1 | 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. |
| NRS Pain With Movement on POD1 | 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. |
| Worst NRS Pain on POD1 | 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. |
| Least NRS Pain on POD1 | 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. |
| NRS Pain at Rest 4 Weeks After Surgery | 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. |
| NRS Pain With Movement 4 Weeks After Surgery | 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. |
| NRS Pain at Rest on POD2 | 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. |
| Least NRS Pain 4 Weeks After Surgery | 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. |
| NRS Pain at Rest 3 Months After Surgery | 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. |
| NRS Pain With Movement 3 Months After Surgery | 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. |
| Worst NRS Pain 3 Months After Surgery | 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. |
| Least NRS Pain 3 Months After Surgery | 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. |
| NRS Pain at Rest 6 Months After Surgery | 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. |
| Least NRS Pain 6 Months After Surgery | 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. |
| Worst NRS Pain 6 Months After Surgery | 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. |
| Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | 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. |
| Postoperative painDETECT Scores | 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. |
| Types of Preoperative Medications | Before surgery | Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications. |
| Worst NRS Pain 4 Weeks After Surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 32 |
| 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). | 130 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patients were found have meet criteria under the exclusion criterion | 2 |
| Overall Study | Protocol Violation | 14 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Total Knee Arthroplasty Patients (Stiff) | Total Knee Arthroplasty Patients (Non-Stiff) | Total |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 8.9 | 67.3 years STANDARD_DEVIATION 7.9 | 66.9 years STANDARD_DEVIATION 8.2 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 11 Participants | 15 Participants |
| Race/Ethnicity, Customized Declined/Unknown | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 26 Participants | 116 Participants | 142 Participants |
| Sex: Female, Male Female | 17 Participants | 75 Participants | 92 Participants |
| Sex: Female, Male Male | 15 Participants | 55 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 162 |
| other Total, other adverse events | 0 / 162 |
| serious Total, serious adverse events | 0 / 162 |
Outcome results
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.
Time frame: 6 months after date of surgery
Population: Some patients lost to follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Knee Arthroplasty Patients | Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS) | 10 Participants |
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.
Time frame: 3 months after date of surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Least NRS Pain 3 Months After Surgery | 0.8 score on a scale | Standard Deviation 1.3 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Least NRS Pain 3 Months After Surgery | 0.3 score on a scale | Standard Deviation 0.9 |
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.
Time frame: 4 weeks after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Least NRS Pain 4 Weeks After Surgery | 1.5 score on a scale | Standard Deviation 1.6 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Least NRS Pain 4 Weeks After Surgery | 0.8 score on a scale | Standard Deviation 1.3 |
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.
Time frame: 6 months after date of surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Least NRS Pain 6 Months After Surgery | 0.7 score on a scale | Standard Deviation 1.3 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Least NRS Pain 6 Months After Surgery | 0.1 score on a scale | Standard Deviation 0.4 |
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.
Time frame: 1 day after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Least NRS Pain on POD1 | 1.5 units on a scale | Standard Deviation 2.3 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Least NRS Pain on POD1 | 1.2 units on a scale | Standard Deviation 1.7 |
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.
Time frame: 2 days after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Least NRS Pain on POD2 | 3.1 score on a scale | Standard Deviation 2.4 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Least NRS Pain on POD2 | 1.8 score on a scale | Standard Deviation 2 |
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.
Time frame: 3 months after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | NRS Pain at Rest 3 Months After Surgery | 2.4 score on a scale | Standard Deviation 2.8 |
| Total Knee Arthroplasty Patients (Non-Stiff) | NRS Pain at Rest 3 Months After Surgery | 0.8 score on a scale | Standard Deviation 1.5 |
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.
Time frame: 4 weeks after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | NRS Pain at Rest 4 Weeks After Surgery | 2.9 score on a scale | Standard Deviation 2.3 |
| Total Knee Arthroplasty Patients (Non-Stiff) | NRS Pain at Rest 4 Weeks After Surgery | 2 score on a scale | Standard Deviation 1.7 |
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.
Time frame: 6 months after date of surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | NRS Pain at Rest 6 Months After Surgery | 2.4 score on a scale | Standard Deviation 2.4 |
| Total Knee Arthroplasty Patients (Non-Stiff) | NRS Pain at Rest 6 Months After Surgery | 0.4 score on a scale | Standard Deviation 0.8 |
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.
Time frame: 1 day after surgery
Population: some lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | NRS Pain at Rest on POD1 | 4.9 units on a scale | Standard Deviation 3.6 |
| Total Knee Arthroplasty Patients (Non-Stiff) | NRS Pain at Rest on POD1 | 3.2 units on a scale | Standard Deviation 2.5 |
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.
Time frame: 2 days after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | NRS Pain at Rest on POD2 | 5.3 score on a scale | Standard Deviation 3 |
| Total Knee Arthroplasty Patients (Non-Stiff) | NRS Pain at Rest on POD2 | 3.2 score on a scale | Standard Deviation 2.2 |
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.
Time frame: 3 months after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | NRS Pain With Movement 3 Months After Surgery | 3.4 score on a scale | Standard Deviation 2.7 |
| Total Knee Arthroplasty Patients (Non-Stiff) | NRS Pain With Movement 3 Months After Surgery | 1.5 score on a scale | Standard Deviation 1.9 |
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.
Time frame: 4 weeks after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | NRS Pain With Movement 4 Weeks After Surgery | 4.3 score on a scale | Standard Deviation 2.9 |
| Total Knee Arthroplasty Patients (Non-Stiff) | NRS Pain With Movement 4 Weeks After Surgery | 3.3 score on a scale | Standard Deviation 2.2 |
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.
Time frame: 1 day after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | NRS Pain With Movement on POD1 | 7.6 units on a scale | Standard Deviation 2.8 |
| Total Knee Arthroplasty Patients (Non-Stiff) | NRS Pain With Movement on POD1 | 4.9 units on a scale | Standard Deviation 2.7 |
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.
Time frame: 2 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | NRS Pain With Movement on POD2 | 7.4 score on a scale | Standard Deviation 2.1 |
| Total Knee Arthroplasty Patients (Non-Stiff) | NRS Pain With Movement on POD2 | 6.2 score on a scale | Standard Deviation 2.2 |
Secondary
Patients Who Experienced Postoperative Joint Stiffness
The number of patients that experienced postoperative joint stiffness, defined as ≤95 degrees range of motion.
Time frame: 6 weeks after date of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Knee Arthroplasty Patients | Patients Who Experienced Postoperative Joint Stiffness | 32 Participants |
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.
Time frame: 4 weeks, 3 months, and 6 months after date of surgery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Knee Arthroplasty Patients | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Symptoms 4 weeks | 37 score on a scale | Standard Deviation 11 |
| Total Knee Arthroplasty Patients | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Quality of Life 4 weeks | 18 score on a scale | Standard Deviation 15 |
| Total Knee Arthroplasty Patients | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Symptoms 3 month | 32 score on a scale | Standard Deviation 14 |
| Total Knee Arthroplasty Patients | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Quality of Life 3 month | 19 score on a scale | Standard Deviation 26 |
| Total Knee Arthroplasty Patients | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Symptoms 6 month | 34 score on a scale | Standard Deviation 15 |
| Total Knee Arthroplasty Patients | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Quality of Life 6 month | 41 score on a scale | Standard Deviation 21 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Symptoms 6 month | 34 score on a scale | Standard Deviation 13 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Symptoms 4 weeks | 32 score on a scale | Standard Deviation 12 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Quality of Life 3 month | 37 score on a scale | Standard Deviation 20 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Quality of Life 4 weeks | 20 score on a scale | Standard Deviation 17 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Quality of Life 6 month | 48 score on a scale | Standard Deviation 21 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores | KOOS Symptoms 3 month | 33 score on a scale | Standard Deviation 13 |
Secondary
Postoperative Knee Range of Motion
Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees.
Time frame: 6 weeks after date of surgery
Population: some patients did not answer the questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Postoperative Knee Range of Motion | 84 degrees | Standard Deviation 15.6 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Postoperative Knee Range of Motion | 115.3 degrees | Standard Deviation 8.5 |
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.
Time frame: 4 weeks, 3 months, and 6 months after date of surgery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Knee Arthroplasty Patients | Postoperative painDETECT Scores | 4 weeks | 6.7 score on a scale | Standard Deviation 4.1 |
| Total Knee Arthroplasty Patients | Postoperative painDETECT Scores | 3 months | 6.2 score on a scale | Standard Deviation 4.5 |
| Total Knee Arthroplasty Patients | Postoperative painDETECT Scores | 6 months | 4.9 score on a scale | Standard Deviation 7 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Postoperative painDETECT Scores | 4 weeks | 7 score on a scale | Standard Deviation 4.3 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Postoperative painDETECT Scores | 3 months | 3.5 score on a scale | Standard Deviation 4 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Postoperative painDETECT Scores | 6 months | 1.4 score on a scale | Standard Deviation 2.4 |
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.
Time frame: Before surgery
Population: some patients did not answer the questionnaire
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Types of Preoperative Medications | used statins | 73 Participants |
| Total Knee Arthroplasty Patients | Types of Preoperative Medications | used gabapentin | 0 Participants |
| Total Knee Arthroplasty Patients | Types of Preoperative Medications | used anticonvulsants | 4 Participants |
| Total Knee Arthroplasty Patients | Types of Preoperative Medications | used selective serotonin reuptake inhibitors | 20 Participants |
| Total Knee Arthroplasty Patients | Types of Preoperative Medications | used tricyclic antidepressants | 1 Participants |
| Total Knee Arthroplasty Patients | Types of Preoperative Medications | used serotonin-norepinephrine reuptake inhibitors | 4 Participants |
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.
Time frame: 3 months after date of surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Worst NRS Pain 3 Months After Surgery | 4.1 score on a scale | Standard Deviation 2.5 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Worst NRS Pain 3 Months After Surgery | 2.3 score on a scale | Standard Deviation 2.2 |
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.
Time frame: 4 weeks after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Worst NRS Pain 4 Weeks After Surgery | 5.9 score on a scale | Standard Deviation 2.2 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Worst NRS Pain 4 Weeks After Surgery | 5.4 score on a scale | Standard Deviation 2.3 |
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.
Time frame: 6 months after date of surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Worst NRS Pain 6 Months After Surgery | 6.5 score on a scale | Standard Deviation 2.4 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Worst NRS Pain 6 Months After Surgery | 1.4 score on a scale | Standard Deviation 1.6 |
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.
Time frame: 1 day after surgery
Population: Some patients lost to follow up or did not answer questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Worst NRS Pain on POD1 | 7.7 score on a scale | Standard Deviation 2.6 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Worst NRS Pain on POD1 | 6 score on a scale | Standard Deviation 2.7 |
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.
Time frame: 2 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Knee Arthroplasty Patients | Worst NRS Pain on POD2 | 9.1 score on a scale | Standard Deviation 1.4 |
| Total Knee Arthroplasty Patients (Non-Stiff) | Worst NRS Pain on POD2 | 7.7 score on a scale | Standard Deviation 2 |