Trial Outcomes & Findings for Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application (NCT NCT02370420)

Last Updated: 2018-02-19

Results Overview

The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It measures five items of pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68); thus, the total score range is 0-96. A higher value indicates a worst outcome. Only the final measures (at 24 weeks) are presented as part of the final analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

56 participants

Primary outcome timeframe

Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks

Results posted on

2018-02-19

Participant Flow

The location of recruitment was the Orthopaedic and Traumatology consultation.

After the sign of the informed consent, the patients enrollment were assigned in the group of single injection or triple injection according to a randomization plan.

Participant milestones

Participant milestones
Measure	Unique Application of PRP Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home	Triple Application of PRP Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home
Overall Study STARTED	29	27
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	14	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Unique Application of PRP Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home	Triple Application of PRP Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home
Overall Study Physician Decision	3	3
Overall Study Lost to Follow-up	11	9

Baseline Characteristics

The values were obtained only form the patients who completed the study and that were included in the final analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unique Application of PRP n=15 Participants Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home	Triple Application of PRP n=15 Participants Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	54.46 years STANDARD_DEVIATION 10.68 • n=5 Participants	58.77 years STANDARD_DEVIATION 11.19 • n=7 Participants	56.61 years STANDARD_DEVIATION 10.93 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Mexico	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Physical Component of the Short Form-12 of the Health Survey (SF-12)	33.61 units on a scale STANDARD_DEVIATION 9.14 • n=5 Participants • The values were obtained only form the patients who completed the study and that were included in the final analysis.	37.25 units on a scale STANDARD_DEVIATION 7.19 • n=7 Participants • The values were obtained only form the patients who completed the study and that were included in the final analysis.	35.43 units on a scale STANDARD_DEVIATION 8.18 • n=5 Participants • The values were obtained only form the patients who completed the study and that were included in the final analysis.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	41.27 units on a scale STANDARD_DEVIATION 19 • n=5 Participants	41 units on a scale STANDARD_DEVIATION 16.50 • n=7 Participants	41.13 units on a scale STANDARD_DEVIATION 17.75 • n=5 Participants
Visual Analog Scale (VAS)	7.06 cm STANDARD_DEVIATION 2.21 • n=5 Participants	6.46 cm STANDARD_DEVIATION 2.47 • n=7 Participants	7.03 cm STANDARD_DEVIATION 2.34 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks

Outcome measures

Outcome measures
Measure	Unique Application of PRP n=15 Participants Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home	Triple Application of PRP n=15 Participants Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home
Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect)	28.53 units on a scale Standard Deviation 14	22.27 units on a scale Standard Deviation 19.07

SECONDARY outcome

Timeframe: Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks

SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100. The data obtained with the SF-12 has been developed, tested and validated by Quality Metric Incorporated. Only the final measures (at 24 weeks) from the physical domain are presented as part of the final analysis.

Outcome measures

Outcome measures
Measure	Unique Application of PRP n=15 Participants Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home	Triple Application of PRP n=15 Participants Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home
Change in the SF-12 Health Survey (Quality of Life)	41.79 units on a scale Standard Deviation 6.71	44.74 units on a scale Standard Deviation 10.65

SECONDARY outcome

Timeframe: Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks

The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Only the final measures (at 24 weeks) are presented as part of the final analysis.

Outcome measures

Outcome measures
Measure	Unique Application of PRP n=15 Participants Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home	Triple Application of PRP n=15 Participants Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home
Change in the Visual Analog Scale (VAS) (Global Pain)	4.46 cm Standard Deviation 2.06	3.26 cm Standard Deviation 3.12

Adverse Events

Triple Application of PRP

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Unique Application of PRP

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Triple Application of PRP n=15 participants at risk Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home	Unique Application of PRP n=15 participants at risk Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home Platelet-Rich Plasma: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections rehabilitation exercises: Patients would been shown rehabilitation exercises, to perform them at home
Skin and subcutaneous tissue disorders Pain, inflammation	6.7% 1/15 • Number of events 1 • Six months All patients were asked and evaluated for possibles adverse events at time-points of evaluation (most commonly pain at the site of injection). Specific attention was provided for platelet-rich plasma (PRP) treated patients.	6.7% 1/15 • Number of events 1 • Six months All patients were asked and evaluated for possibles adverse events at time-points of evaluation (most commonly pain at the site of injection). Specific attention was provided for platelet-rich plasma (PRP) treated patients.

Additional Information

Felix Vilchez Cavazos

Universidad Autonoma de Nuevo Leon

Phone: 811 049 80 70

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place