A Phase 3 interventional study of Platelet-Rich Plasma and rehabilitation exercises in Osteoarthritis, sponsored by Universidad Autonoma de Nuevo Leon. Completed at 1 site in Mexico. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Universidad Autonoma de Nuevo Leon · Phase 3, Interventional, and Treatment
The investigators include patients attending the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment is medical. Patients will be divided into two groups. In both groups, they will be given verbal, clear and detailed information on the approach to follow, the intra-articular application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first group will be held single application, while in the second group three applications will be made at an interval of two weeks each. Both groups will be assessed before and after application, together with outpatient follow-up by the SF-12 Health Survey (SF-12), Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analogue Scale (VAS).
Osteoarthritis (OA ) refers to a clinical syndrome of joint pain with a multifactorial etiology , with the gradual loss of articular cartilage, osteophytosis formation, subchondral bone remodeling and inflammation of the joint. Is the most common cause of knee pain, and one of the leading causes of disability and dependence of the adult population that generates large expenditures in the area of health.
The clinical diagnosis of OA is primarily clinical - radiological, based on a complete medical history and physical examination directed. No laboratory studies are routinely requested since there is no specific diagnostic test or pathognomonic for diagnosis. Physical examination is most important.
The ideal treatment is a multidisciplinary one, and must meet the objectives of achieving anesthesia, reduce disability and improve joint function and patient's quality life, with low toxicity of drugs. Several conservative treatments are recommended by clinical guidelines. Some nonpharmacologic measures are: patient education, exercise, weight loss, modification of footwear, using the local cryotherapy, acupuncture and electromagnetic therapy. Drug therapy can be summarized in paracetamol, NSAIDs, opioids, and slow-acting drugs. If these oral drugs do not work can be administered intra-articularly (corticosteroids, viscosupplementation products, and blood derivates).
Platelet-Rich Plasma (PRP) is a rich source of growth factors such as Platelet-derived growth factor (PDGF), transforming growth factor β (TGF- β ), vascular endothelial growth factor (VEGF), like growth factor type I insulin (IGF- I), vascular endothelial growth factor (EGF), among others. For these growth factors are released, the platelets need to be activated by substances such as calcium chloride, calcium gluconate or thrombin. Once activated , growth factors are secreted, reaching a peak concentration 10 minutes. It is known that GF, PDGF and TGF -B stimulate chondrogenesis helping solving clinical manifestations of patients studied.
The investigators include patients attending the outpatient clinic in the area of Orthopedics and Traumatology of our hospital with a diagnosis of knee osteoarthritis, which treatment is medical. Patients will be divided into two groups. In both groups, they will be given verbal, clear and detailed information on the approach to follow, the intra-articular application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first group will be held single application, while in the second group three applications will be made at an interval of two weeks each. Both groups will be assessed before and after application, together with outpatient follow-up by the SF-12, WOMAC and Visual Analogue Scale.
The PRP would be obtained through previous an asepsis and antisepsis of the patient's arm, 30cc of blood form the Basilic vein would be extracted.
Each sample will initially centrifuged at 1800 rpm for 10 minutes in a centrifuge and the sample would be separated into three layers : 1- Red Cell (lower) White 2- (plasma rich in growth factors) Yellow 3- ( plasma poor in growth factors ).1000 ul PRP ( yellow layer ) is extracted by placing it in 15 mL Falcon tubes for subsequently performing a second step of centrifugation at 3400 rpm for 12 minutes. The top layer of platelet poor plasma is removed and stayed with the lower layer, the PRP (3-5 mL ) . Before application in the patient's knee,calcium gluconate 10% was added, 0.15 mL per milliliter of PRP obtained. The sample then would be aspirated with a 10 mL syringe for the application to the patient.
After asepsis and antisepsis of where the puncture site , sterile drapes were placed clearing the workspace, the PRP is injected with a technique 45 ° at the corner superior- lateral patellar, reaching the joint capsule. Once injected the PRP, a sterile pad on the application area will be placed.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 56 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Exclusion Criteria:
Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home
Biological: Platelet-Rich Plasma · Behavioral: rehabilitation exercises
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
Biological: Platelet-Rich Plasma · Behavioral: rehabilitation exercises
Autologous Platelet-Rich Plasma will be applied by a intra-articular injections
Patients would been shown rehabilitation exercises, to perform them at home
Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect)
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.
Time frame: Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks
Change in the SF-12 Health Survey (Quality of Life)
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.
Time frame: Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks
Change in the Visual Analog Scale (VAS) (Global Pain)
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.
Time frame: Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks
The location of recruitment was the Orthopaedic and Traumatology consultation.
| Milestone | Unique Application of PRP | Triple Application of PRP |
|---|---|---|
| Started | 29 | 27 |
| Completed | 15 | 15 |
| Not completed | 14 | 12 |
| Withdrew: Physician decision | 3 | 3 |
| Withdrew: Lost to follow-up | 11 | 9 |
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.
| units on a scale | Unique Application of PRP | Triple Application of PRP |
|---|---|---|
| Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect) | 28.53 ± 14 | 22.27 ± 19.07 |
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.
| units on a scale | Unique Application of PRP | Triple Application of PRP |
|---|---|---|
| Change in the SF-12 Health Survey (Quality of Life) | 41.79 ± 6.71 | 44.74 ± 10.65 |
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.
| cm | Unique Application of PRP | Triple Application of PRP |
|---|---|---|
| Change in the Visual Analog Scale (VAS) (Global Pain) | 4.46 ± 2.06 | 3.26 ± 3.12 |
Collected over Six months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Triple Application of PRP | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| Unique Application of PRP | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| Event | Triple Application of PRP | Unique Application of PRP |
|---|---|---|
| Pain, inflammationSkin and subcutaneous tissue disorders | 1/15 | 1/15 |
The values were obtained only from the patients who completed the study and that were included in the final analysis.
| Age, Categorical(Participants) | Unique Application of PRP | Triple Application of PRP | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 10 | 23 |
| >=65 years | 2 | 5 | 7 |
| Age, Continuous(years) | Unique Application of PRP | Triple Application of PRP | Total |
|---|---|---|---|
| Mean | 54.46 ± 10.68 | 58.77 ± 11.19 | 56.61 ± 10.93 |
| Sex: Female, Male(Participants) | Unique Application of PRP | Triple Application of PRP | Total |
|---|---|---|---|
| Female | 14 | 11 | 25 |
| Male | 1 | 4 | 5 |
| Region of Enrollment(participants) | Unique Application of PRP | Triple Application of PRP | Total |
|---|---|---|---|
| Mexico | 15 | 15 | 30 |
| Physical Component of the Short Form-12 of the Health Survey (SF-12)(units on a scale) | Unique Application of PRP | Triple Application of PRP | Total |
|---|---|---|---|
| Mean | 33.61 ± 9.14 | 37.25 ± 7.19 | 35.43 ± 8.18 |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(units on a scale) | Unique Application of PRP | Triple Application of PRP | Total |
|---|---|---|---|
| Mean | 41.27 ± 19 | 41 ± 16.50 | 41.13 ± 17.75 |
| Visual Analog Scale (VAS)(cm) | Unique Application of PRP | Triple Application of PRP | Total |
|---|---|---|---|
| Mean | 7.06 ± 2.21 | 6.46 ± 2.47 | 7.03 ± 2.34 |
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Universidad Autonoma de Nuevo Leon