An observational study in Pain and Joint Stiffness, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Hospital for Special Surgery, New York · Observational
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.
4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 179 is above the median of 100 across 792 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.
Exclusion Criteria:
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Total Knee Arthroplasty Patients |
|---|---|
| Started | 179 |
| Pod 1 follow up | 162 |
| Pod 2 follow up | 162 |
| 4 weeks post-op | 162 |
| 6 weeks post-op | 162 |
| 3 month post-op | 162 |
| 6 months post-op | 162 |
| Stratified to "stiff" group | 32 |
| Stratified to "non-stiff" group | 130 |
| Completed | 162 |
| Not completed | 17 |
| Withdrew: Protocol violation | 14 |
| Withdrew: Patients were found have meet criteria under the exclusion criterion | 2 |
| Withdrew: Withdrawal by subject | 1 |
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.
| Participants | Total Knee Arthroplasty Patients |
|---|---|
| Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS) | 10 |
The number of patients that experienced postoperative joint stiffness, defined as ≤95 degrees range of motion.
| Participants | Total Knee Arthroplasty Patients |
|---|---|
| Patients Who Experienced Postoperative Joint Stiffness | 32 |
Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees.
| degrees | Total Knee Arthroplasty Patients (Stiff) | Total Knee Arthroplasty Patients (Non-Stiff) |
|---|---|---|
| Postoperative Knee Range of Motion | 84 ± 15.6 | 115.3 ± 8.5 |
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.
| units on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| NRS Pain at Rest on POD1 | 4.9 ± 3.6 | 3.2 ± 2.5 |
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.
| units on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| NRS Pain With Movement on POD1 | 7.6 ± 2.8 | 4.9 ± 2.7 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| Worst NRS Pain on POD1 | 7.7 ± 2.6 | 6 ± 2.7 |
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.
| units on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| Least NRS Pain on POD1 | 1.5 ± 2.3 | 1.2 ± 1.7 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| NRS Pain at Rest on POD2 | 5.3 ± 3 | 3.2 ± 2.2 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| NRS Pain With Movement on POD2 | 7.4 ± 2.1 | 6.2 ± 2.2 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| Worst NRS Pain on POD2 | 9.1 ± 1.4 | 7.7 ± 2 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| Least NRS Pain on POD2 | 3.1 ± 2.4 | 1.8 ± 2 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| NRS Pain at Rest 4 Weeks After Surgery | 2.9 ± 2.3 | 2 ± 1.7 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| NRS Pain With Movement 4 Weeks After Surgery | 4.3 ± 2.9 | 3.3 ± 2.2 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| Worst NRS Pain 4 Weeks After Surgery | 5.9 ± 2.2 | 5.4 ± 2.3 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| Least NRS Pain 4 Weeks After Surgery | 1.5 ± 1.6 | 0.8 ± 1.3 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| NRS Pain at Rest 3 Months After Surgery | 2.4 ± 2.8 | 0.8 ± 1.5 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 3 Months Post-op |
|---|---|---|
| NRS Pain With Movement 3 Months After Surgery | 3.4 ± 2.7 | 1.5 ± 1.9 |
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.
| score on a scale | NRS Pain is >=4 With Activity 3 Months Post-op | NRS Pain is NOT >4 With Activity 3 Months Post-op |
|---|---|---|
| Worst NRS Pain 3 Months After Surgery | 4.1 ± 2.5 | 2.3 ± 2.2 |
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.
| score on a scale | NRS Pain is >=4 With Activity 3 Months Post-op | NRS Pain is NOT >4 With Activity 3 Months Post-op |
|---|---|---|
| Least NRS Pain 3 Months After Surgery | 0.8 ± 1.3 | 0.3 ± 0.9 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| NRS Pain at Rest 6 Months After Surgery | 2.4 ± 2.4 | 0.4 ± 0.8 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| Least NRS Pain 6 Months After Surgery | 0.7 ± 1.3 | 0.1 ± 0.4 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| Worst NRS Pain 6 Months After Surgery | 6.5 ± 2.4 | 1.4 ± 1.6 |
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.
| score on a scale | Total Knee Arthroplasty Patients (Stiff) | Total Knee Arthroplasty Patients (Non-Stiff) |
|---|---|---|
| KOOS Symptoms 4 weeks | 37 ± 11 | 32 ± 12 |
| KOOS Quality of Life 4 weeks | 18 ± 15 | 20 ± 17 |
| KOOS Symptoms 3 month | 32 ± 14 | 33 ± 13 |
| KOOS Quality of Life 3 month | 19 ± 26 | 37 ± 20 |
| KOOS Symptoms 6 month | 34 ± 15 | 34 ± 13 |
| KOOS Quality of Life 6 month | 41 ± 21 | 48 ± 21 |
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.
| score on a scale | NRS Pain is >=4 With Activity 6 Months Post-op | NRS Pain is NOT >4 With Activity 6 Months Post-op |
|---|---|---|
| 4 weeks | 6.7 ± 4.1 | 7 ± 4.3 |
| 3 months | 6.2 ± 4.5 | 3.5 ± 4 |
| 6 months | 4.9 ± 7 | 1.4 ± 2.4 |
Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.
| Participants | Total Knee Arthroplasty Patients |
|---|---|
| used statins | 73 |
| used gabapentin | 0 |
| used anticonvulsants | 4 |
| used selective serotonin reuptake inhibitors | 20 |
| used tricyclic antidepressants | 1 |
| used serotonin-norepinephrine reuptake inhibitors | 4 |
Collected over up to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Knee Arthroplasty Patients | 0/162 (0%) | 0/162 (0%) | 0/162 (0%) |
| Age, Continuous(years) | Total Knee Arthroplasty Patients (Stiff) | Total Knee Arthroplasty Patients (Non-Stiff) | Total |
|---|---|---|---|
| Mean | 65.8 ± 8.9 | 67.3 ± 7.9 | 66.9 ± 8.2 |
| Sex: Female, Male(Participants) | Total Knee Arthroplasty Patients (Stiff) | Total Knee Arthroplasty Patients (Non-Stiff) | Total |
|---|---|---|---|
| Female | 17 | 75 | 92 |
| Male | 15 | 55 | 70 |
| Race/Ethnicity, Customized(Participants) | Total Knee Arthroplasty Patients (Stiff) | Total Knee Arthroplasty Patients (Non-Stiff) | Total |
|---|---|---|---|
| Asian | 1 | 1 | 2 |
| Black or African American | 4 | 11 | 15 |
| White | 26 | 116 | 142 |
| Declined/Unknown | 1 | 2 | 3 |
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Hospital for Special Surgery, New York