Trial Outcomes & Findings for Comparison of Acetaminophen and PRP Therapy for Knee OA (NCT NCT01782885)

NCT ID: NCT01782885

Last Updated: 2015-11-20

Results Overview

The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 543 participants
• Primary outcome timeframe: 0 weeks
• Results posted on: 2015-11-20

Participant Flow

Patients diagnosed with degenerative osteoarthritis were recruited from May 2013 to November 2015 in the Service of Orthopedics and Traumatology at the University Hospital "Dr. José Eleuterio González" of the Autonomous University of Nuevo León in Monterrey, México.

Only patients meeting inclusion criteria were assigned to a group (radiographic grade I and II osteoarthritis, mainly). Importantly, patients with previous surgical interventions, with concomitant diseases or with Hb values of <11 g/dL and platelet values of <150,000/µL were excluded prior to group assignment.

Participant milestones

Measure	Acetaminophen Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Study STARTED	36	39
Overall Study COMPLETED	32	33
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Measure	Acetaminophen Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Study Lost to Follow-up	4	6

Baseline Characteristics

Comparison of Acetaminophen and PRP Therapy for Knee OA

Baseline characteristics by cohort

Measure	Acetaminophen n=32 Participants Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 Participants Intra-articular injection of PRP: Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks treatment).	Total n=65 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 11.4 • n=5 Participants	57.2 years STANDARD_DEVIATION 8.1 • n=7 Participants	56.4 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Body Mass Index (BMI)	29.5 kg/m2 STANDARD_DEVIATION 3.8 • n=5 Participants	32.2 kg/m2 STANDARD_DEVIATION 6.2 • n=7 Participants	30.9 kg/m2 STANDARD_DEVIATION 5.0 • n=5 Participants
Grade of Osteoarthritis Kellgren-Lawrence Grade I	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants
Grade of Osteoarthritis Kellgren-Lawrence Grade II	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants
Visual Analog Scale (VAS)	5.9 cm STANDARD_DEVIATION 2.2 • n=5 Participants	4.9 cm STANDARD_DEVIATION 2.4 • n=7 Participants	5.4 cm STANDARD_DEVIATION 2.3 • n=5 Participants
Western Ontario and McMaster Universities Arthritis Index (WOMAC)	35.5 units on a scale STANDARD_DEVIATION 19.0 • n=5 Participants	35.7 units on a scale STANDARD_DEVIATION 19.5 • n=7 Participants	35.6 units on a scale STANDARD_DEVIATION 19.3 • n=5 Participants

PRIMARY outcome

Timeframe: 0 weeks

The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Outcome measures

Measure	Acetaminophen n=32 Participants Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 Participants Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness (0 weeks)	3.0 units on a scale Standard Deviation 2.1	2.9 units on a scale Standard Deviation 2.0
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (0 weeks)	8.0 units on a scale Standard Deviation 4.3	7.4 units on a scale Standard Deviation 4.0
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Functional capacity (0 weeks)	24.4 units on a scale Standard Deviation 13.7	25.3 units on a scale Standard Deviation 14.3
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total score (0 weeks)	35.5 units on a scale Standard Deviation 19.0	35.7 units on a scale Standard Deviation 19.5

PRIMARY outcome

Timeframe: 6 weeks

The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Outcome measures

Measure	Acetaminophen n=32 Participants Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 Participants Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Functional capacity (6 weeks)	18.2 units on a scale Standard Deviation 12.0	8.7 units on a scale Standard Deviation 8.0
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness (6 weeks)	2.3 units on a scale Standard Deviation 1.8	1.1 units on a scale Standard Deviation 1.1
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (6 weeks)	5.8 units on a scale Standard Deviation 2.9	3.1 units on a scale Standard Deviation 2.6
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total score (6 weeks)	26.2 units on a scale Standard Deviation 16.0	12.8 units on a scale Standard Deviation 11.0

PRIMARY outcome

Timeframe: 12 weeks

The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Outcome measures

Measure	Acetaminophen n=32 Participants Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 Participants Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness (12 weeks)	2.2 units on a scale Standard Deviation 2.2	0.9 units on a scale Standard Deviation 1.3
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (12 weeks)	5.7 units on a scale Standard Deviation 4.1	2.7 units on a scale Standard Deviation 2.4
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Functional capacity (12 weeks)	18.4 units on a scale Standard Deviation 13.1	8.1 units on a scale Standard Deviation 7.2
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total score (12 weeks)	26.3 units on a scale Standard Deviation 17.8	12.0 units on a scale Standard Deviation 10.6

PRIMARY outcome

Timeframe: 24 weeks

The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Outcome measures

Measure	Acetaminophen n=32 Participants Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 Participants Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness (24 weeks)	1.9 units on a scale Standard Deviation 1.9	0.8 units on a scale Standard Deviation 1.1
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (24 weeks)	5.3 units on a scale Standard Deviation 3.9	2.9 units on a scale Standard Deviation 2.2
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Functional capacity (24 weeks)	16.7 units on a scale Standard Deviation 13.3	7.9 units on a scale Standard Deviation 7.7
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total score (24 weeks)	23.5 units on a scale Standard Deviation 18.4	11.7 units on a scale Standard Deviation 10.0

SECONDARY outcome

Timeframe: 0-24 weeks

The visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their current level of pain by indicating a position along a continuous line of 10 cm. Subject is asked: on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what you rate your current pain?

Outcome measures

Measure	Acetaminophen n=32 Participants Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 Participants Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Change in Visual Analog Scale (VAS) VAS (0 weeks)	5.9 Centimeters Standard Deviation 2.2	4.9 Centimeters Standard Deviation 2.4
Change in Visual Analog Scale (VAS) VAS (6 weeks)	3.8 Centimeters Standard Deviation 2.2	1.9 Centimeters Standard Deviation 1.6
Change in Visual Analog Scale (VAS) VAS (12 weeks)	4.1 Centimeters Standard Deviation 2.6	1.9 Centimeters Standard Deviation 2.0
Change in Visual Analog Scale (VAS) VAS (24 weeks)	3.7 Centimeters Standard Deviation 2.7	2.2 Centimeters Standard Deviation 2.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 weeks

The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Acetaminophen n=32 Participants Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 Participants Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Change in SF-12v2 Health Survey Mental Component Summary	50.8 units on a scale Standard Deviation 9.9	44.2 units on a scale Standard Deviation 11.8
Change in SF-12v2 Health Survey Physical Component Summary	37.7 units on a scale Standard Deviation 9.3	38.0 units on a scale Standard Deviation 8.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Acetaminophen n=32 Participants Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 Participants Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Change in SF-12v2 Health Survey Mental Component Summary	49.8 units on a scale Standard Deviation 9.3	55.4 units on a scale Standard Deviation 8.7
Change in SF-12v2 Health Survey Physical Component Summary	41.1 units on a scale Standard Deviation 9.9	47.6 units on a scale Standard Deviation 7.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Acetaminophen n=32 Participants Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 Participants Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Change in SF-12v2 Health Survey Mental Component Summary	50.7 units on a scale Standard Deviation 8.7	55.9 units on a scale Standard Deviation 7.9
Change in SF-12v2 Health Survey Physical Component Summary	41.7 units on a scale Standard Deviation 8.5	48.8 units on a scale Standard Deviation 7.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Acetaminophen n=32 Participants Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 Participants Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Change in SF-12v2 Health Survey Mental Component Summary	52.3 units on a scale Standard Deviation 7.2	54.3 units on a scale Standard Deviation 7.6
Change in SF-12v2 Health Survey Physical Component Summary	41.4 units on a scale Standard Deviation 7.4	49.9 units on a scale Standard Deviation 8.1

Adverse Events

Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intra-articular Injection of PRP

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acetaminophen n=32 participants at risk Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.	Intra-articular Injection of PRP n=33 participants at risk Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Skin and subcutaneous tissue disorders Pain, inflammation	0.00% 0/32 • 6 months All patients were asked and evaluated for possibles adverse events at time-points of evaluation. Specific attention was provided for PRP treated patients.	12.1% 4/33 • Number of events 4 • 6 months All patients were asked and evaluated for possibles adverse events at time-points of evaluation. Specific attention was provided for PRP treated patients.

Additional Information

M Sc Mario Simental-Mendía

Universidad Autónoma de Nuevo León

Phone: +52 (81) 8329 4174

Email: mario.simental@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place