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Opioid-free Accelerated Recovery Total Knee Arthroplasty

Opioid-Free Accelerated Recovery Total Knee Arthroplasty

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03647709
Enrollment
400
Registered
2018-08-27
Start date
2018-10-01
Completion date
2020-04-30
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee Joint

Brief summary

To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty.

Detailed description

All study patients will receive a standardized protocol * All surgical procedures performed by single surgeon using same implants, approach, pre-op and post-op optimization, and simplified pain protocol at a single hospital or surgery center * Will attempt to minimize the number of anesthesiologists to further control variability in care Methods: 1. Pre-op Optimization * All patients enroll in education program * All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure 2. Total Joint Procedure * Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block 3. Data Collection * Electronic medical record chart review * Pre-op assessment and Post-op assessment (post anesthesia care unit (PACU), Phase II-prior to discharge * Phone calls after discharge * Follow-up assessment in surgeon's office * Swift path / KOOS JR surveys 4. Pain Management Regimen * pre-op physical therapy teaching * post-op multimodal pain regimen

Interventions

OTHERopioids

dosage frequency and duration

Sponsors

Halyard Health
CollaboratorINDUSTRY
St. Elizabeth Medical Center, Utica, NY
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Surgeries to be performed at hospital * Surgeries to be performed at surgery center * Ability to read and understand English * Primary care clearance for patients diagnosed with high blood pressure

Exclusion criteria

* Disease states, patient conditions to exclude: Schizophrenia Bipolar Disease Dementia * Known allergies to local anesthetics * Previous burn to affected extremity * BMI \> 40 * Nonoptimized anemia * Albumin less than 3.5 * A1C \> 8.0

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative12 weeksUsing a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols
Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative12 weeksThe total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative

Secondary

MeasureTime frameDescription
Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement6 weeksSwift path is an Educational tool (diary) for patients undergoing total joint replacement, that patients follow from the initial booking of surgery through their recovery. It guides patients through potential risks involved with joint surgery, through a multimodal pain management protocol for pain prevention and through recovery.
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14Postop Days10-14Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activitypostoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgeryPain level is measured by the Numerical Rating Scale (NRS) for pain utilizing minimum number 0 to maximum number 10 (0 represents no pain and 10 represents worst pain imaginable). The higher the number reported the worst the pain/outcome. This will be used to assess patient's level of pain relating to opioid use and recovery.
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6Postoperative 6 weeksExercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12Postoperative 12 weeksExercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3postoperative 3 weeksExercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgeryThe Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) is a survey that is an assessment and questionnaire that rates a patients joint pain, stiffness and function in daily living. Patients answer questions about joint stiffness, pain and daily activities using the following scoring values: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The values for all questions are added up to get a raw score that ranges from a minimum of 0 to a maximum of 28. This raw score is converted to an interval score using a provided table. The interval score ranges from a minimum of 0 to a maximum of 100 where 0 = total knee disability and 100 = perfect knee health. The higher the score on scale from 0 to 100 the better the outcome.

Countries

United States

Participant flow

Recruitment details

All patients to have total knee arthroplasty. All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C and blood pressure. All patients enrolled in educational program. All patients have pre-op physical therapy teaching.

Participants by arm

ArmCount
Total Knee Arthroplasty
Number of patients that had total knee arthroplasty after meeting study inclusion criteria
386
Total386

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up5
Overall StudyPhysician Decision6
Overall StudyWithdrawal by Subject3

Baseline characteristics

CharacteristicTotal Knee Arthroplasty
Age, Continuous69 years
ASA
I
8 participants
ASA
II
173 participants
ASA
III
200 participants
ASA
IV
5 participants
BMI31.6 kg/m²
STANDARD_DEVIATION 5.2
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
226 Participants
Sex: Female, Male
Male
160 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 386
other
Total, other adverse events
33 / 386
serious
Total, serious adverse events
4 / 386

Outcome results

Primary

Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative

The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative

Time frame: 12 weeks

Population: Number of Participants Stratified by Total Quantity of Opioid Tablets Taken Post Total Knee Replacement

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Total Knee ArthoplastyNumber of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperativeno opioids72 Participants
Total Knee ArthoplastyNumber of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative1-5 tablets159 Participants
Total Knee ArthoplastyNumber of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative6-10 tablets101 Participants
Total Knee ArthoplastyNumber of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative>10 tablets53 Participants
Primary

Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative

Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols

Time frame: 12 weeks

Population: Number of patents that took no opioids after total knee arthroplasty 12 weeks post surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Total Knee ArthoplastyNumber of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative73 Participants
Secondary

Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity

Pain level is measured by the Numerical Rating Scale (NRS) for pain utilizing minimum number 0 to maximum number 10 (0 represents no pain and 10 represents worst pain imaginable). The higher the number reported the worst the pain/outcome. This will be used to assess patient's level of pain relating to opioid use and recovery.

Time frame: postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery

Population: 386 patients analyzed through 6 weeks; 340 patients analyzed at 12 weeks only.

ArmMeasureGroupValue (MEAN)Dispersion
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 3- Best with Activity1.3 score on a scaleStandard Deviation 1.6
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 3 - Worst with Activity3.1 score on a scaleStandard Deviation 2.1
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 6 - Best at Rest0.1 score on a scaleStandard Deviation 0.6
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 12 - Best at Rest0.0 score on a scaleStandard Deviation 0.2
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 1 - Best with Rest1.0 score on a scaleStandard Deviation 1.8
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 1 - Worst with Rest2.4 score on a scaleStandard Deviation 2.3
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 1 - Best with Activity2.9 score on a scaleStandard Deviation 2.2
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 1 - Worst with Activity4.6 score on a scaleStandard Deviation 2.3
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 2 - Best at Rest1.8 score on a scaleStandard Deviation 2
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 2 - Worst at Rest3.4 score on a scaleStandard Deviation 2.3
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 2 - Best with Activity4.2 score on a scaleStandard Deviation 2
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 2 - Worst with Activity5.9 score on a scaleStandard Deviation 1.9
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 3 - Best at Rest1.0 score on a scaleStandard Deviation 1.6
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 3 - Worst at Rest2.4 score on a scaleStandard Deviation 2.1
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 3 - Best with Activity3.3 score on a scaleStandard Deviation 2.1
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Day 3 - Worst with Activity5.0 score on a scaleStandard Deviation 2
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Days 10-14 - Best at Rest0.5 score on a scaleStandard Deviation 1.2
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Days 10-14 - Worst at Rest2.1 score on a scaleStandard Deviation 2
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Days 10-14 - Best with Activity2.0 score on a scaleStandard Deviation 1.9
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Days 10-14 Worst with Activity4.0 score on a scaleStandard Deviation 2.1
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 3 - Best at Rest0.3 score on a scaleStandard Deviation 0.8
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 3 - Worst at Rest1.5 score on a scaleStandard Deviation 1.9
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 6 - Worst at Rest0.7 score on a scaleStandard Deviation 1.5
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 6 - Best with Activity0.5 score on a scaleStandard Deviation 1.2
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 6 - Worst with Activity1.9 score on a scaleStandard Deviation 2
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 12 - Worst at Rest0.2 score on a scaleStandard Deviation 0.7
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 12 - Best with Activity0.0 score on a scaleStandard Deviation 0.3
Total Knee ArthoplastyComparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With ActivityPostoperative Week 12 - Worst with Activity0.5 score on a scaleStandard Deviation 1.2
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.95% CI: [0.9, 1.2]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.95% CI: [2.2, 2.6]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [2.7, 3.1]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [4.4, 4.8]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [1.6, 2]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [3.2, 3.6]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [4, 4.4]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [5.7, 6.1]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [0.8, 1.2]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [2.2, 2.6]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [3.1, 3.5]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [4.8, 5.2]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [0.4, 0.7]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [1.9, 2.3]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [1.8, 2.2]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [3.8, 4.2]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [0.2, 0.4]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [1.3, 1.7]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [1.2, 1.5]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [2.9, 3.3]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [0, 0.2]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [0.5, 0.8]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [0.4, 0.6]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [1.7, 2]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [0, 0]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [0.1, 0.2]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [0, 0.1]
Comparison: Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity95% CI: [0.4, 0.7]
Secondary

Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)

The Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) is a survey that is an assessment and questionnaire that rates a patients joint pain, stiffness and function in daily living. Patients answer questions about joint stiffness, pain and daily activities using the following scoring values: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The values for all questions are added up to get a raw score that ranges from a minimum of 0 to a maximum of 28. This raw score is converted to an interval score using a provided table. The interval score ranges from a minimum of 0 to a maximum of 100 where 0 = total knee disability and 100 = perfect knee health. The higher the score on scale from 0 to 100 the better the outcome.

Time frame: Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery

Population: 311 patients reported KOOS JR scores at baseline which was prior to surgery. At 6 weeks 379 patients reported scores. At 12 weeks 341 patients reported scores.

ArmMeasureGroupValue (MEAN)Dispersion
Total Knee ArthoplastyKnee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)Baseline prior to surgery53.1 score on a scaleStandard Deviation 11.9
Total Knee ArthoplastyKnee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)Postoperative 6 Week71.8 score on a scaleStandard Deviation 11.8
Total Knee ArthoplastyKnee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)Postoperative 12 Week90.0 score on a scaleStandard Deviation 8.2
Secondary

Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement

Swift path is an Educational tool (diary) for patients undergoing total joint replacement, that patients follow from the initial booking of surgery through their recovery. It guides patients through potential risks involved with joint surgery, through a multimodal pain management protocol for pain prevention and through recovery.

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Total Knee ArthoplastyNumber of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement386 Participants
Secondary

Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14

Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.

Time frame: Postop Days10-14

Population: Physical therapy adherence for patients not taking opioids and taking opioids at 10-14 day follow-up visit

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Total Knee ArthoplastyNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14PT Adherence193 Participants
Total Knee ArthoplastyNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14PT Non-adherence76 Participants
Opiates and Physical Therapy AdherenceNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14PT Adherence64 Participants
Opiates and Physical Therapy AdherenceNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14PT Non-adherence53 Participants
p-value: 0.0015Fisher Exact
Secondary

Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3

Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.

Time frame: postoperative 3 weeks

Population: Physical therapy adherence for patients not taking opioids and taking opioids at 3 week follow-up visit

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Total Knee ArthoplastyNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3PT Adherence290 Participants
Total Knee ArthoplastyNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3PT Non-adherence59 Participants
Opiates and Physical Therapy AdherenceNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3PT Adherence28 Participants
Opiates and Physical Therapy AdherenceNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3PT Non-adherence7 Participants
p-value: 0.6398Fisher Exact
Secondary

Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6

Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.

Time frame: Postoperative 6 weeks

Population: Physical therapy adherence for patients not taking opioids and taking opioids at 6 week follow-up visit

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Total Knee ArthoplastyNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6PT Adherence361 Participants
Total Knee ArthoplastyNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6PT Non-adherence12 Participants
Opiates and Physical Therapy AdherenceNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6PT Non-adherence2 Participants
Opiates and Physical Therapy AdherenceNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6PT Adherence10 Participants
p-value: 0.0658Fisher Exact
Secondary

Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12

Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.

Time frame: Postoperative 12 weeks

Population: Physical therapy adherence for patients not taking opioids and taking opioids at 12 week follow-up visit

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Total Knee ArthoplastyNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12PT Adherence297 Participants
Total Knee ArthoplastyNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12PT Non-adherence38 Participants
Opiates and Physical Therapy AdherenceNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12PT Adherence2 Participants
Opiates and Physical Therapy AdherenceNumber of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12PT Non-adherence0 Participants
p-value: 1Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026