Platelet Rich Plasma Injection for Knee Osteoarthritis
Kata kunci
Abstrak
Deskripsi
The power analysis of this study was calculated based on the sample size studies of previous studies. The difference of d = 3 units between the two means is to have a standard deviation of 6 units. The sample size 200 required to detect with 95% power in the 95% confidence interval to detect.
This study covers 324 patients. All patients were selected according to predefined and established inclusion and exclusion criteria.
Inclusion criteria were: stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging, age between 18 and 80 years, mean Visual Analogue Score (VAS) of >4 of 10 (worst possible pain) over the course of 7 days during the previous month were included on a voluntary basis. Only one knee injection was made to the patients.
Exclusion criteria were OA secondary to joint inflammatory diseases; patients with generalized OA, metabolic diseases of the bone, coexisting backache, the presence of hematological disease (coagulopathy), bilateral symptomatic lesions and advanced stages (grade 4) of OA; patients who had received intra-articular injections within three months or arthroscopic lavage in the previous one year or who were receiving immunosuppressive; patients with current use of anticoagulant medications or NSAIDs used in the five days before blood donation, major axis deviation (more than 15 degree of varus or more than 5 degree of valgus deviation); and patients with a hemoglobin level less than 11.5 g/dL and platelets level less than 100,000/μL or associated co-morbidities, infection, tumor, crystal arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.
The voluntary patients included in this study were divided into four different groups with a computer-assisted randomization program. This groups; group A (n:67) were given a single injection of PRP, group B (n:69) were given a single injection of normal saline (physiological control/placebo), group C (n:66) were given three injection (one per month) of PRP, group D (n:65) were given three injection of normal saline (one per month) (physiological control/placebo).
All patients were evaluated by a blinded researcher with VAS, Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), KUJALA, knee range of motion (ROM) and knee circumference measurement at 1st, 3rd, 6th, 12th and 24th months after treatment.
tanggal
| Terakhir Diverifikasi: | 05/31/2020 |
| Pertama Dikirim: | 06/23/2020 |
| Perkiraan Pendaftaran Telah Dikirim: | 06/29/2020 |
| Pertama Diposting: | 06/30/2020 |
| Pembaruan Terakhir Dikirim: | 06/29/2020 |
| Pembaruan Terakhir Diposting: | 06/30/2020 |
| Tanggal Mulai Studi Sebenarnya: | 05/31/2018 |
| Perkiraan Tanggal Penyelesaian Utama: | 08/22/2019 |
| Perkiraan Tanggal Penyelesaian Studi: | 12/31/2019 |
Kondisi atau penyakit
Intervensi / pengobatan
Biological: PRP
Drug: Saline
Tahap
Kelompok Lengan
| Lengan | Intervensi / pengobatan |
|---|---|
| Experimental: PRP group Intraarticular 5 ml single PRP injection | |
| Placebo Comparator: Saline group Intraarticular 5 ml single saline injection | |
| Experimental: Multiple PRP group Intraarticular 3 dose of 5 ml PRP injection (0, 1, 3 month injection) | |
| Placebo Comparator: Multiple saline group Intraarticular 3 dose of 5 ml saline injection (0, 1, 3 month injection) |
Kriteria kelayakan
| Usia yang Layak untuk Belajar | 18 Years Untuk 18 Years |
| Jenis Kelamin yang Layak untuk Belajar | All |
| Menerima Relawan Sehat | Iya |
| Kriteria | Inclusion Criteria: - stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging - mean VAS pain score of >4 of 10 (worst possible pain) over the course of 7 days during the previous month Exclusion Criteria: - OA secondary to joint inflammatory diseases, - generalized OA, - metabolic diseases of the bone, - coexisting backache, - the presence of hematological disease (coagulopathy), - bilateral symptomatic lesions and advanced stages (grade 4) of OA, - patients who had received intra-articular injections within 3 months or arthroscopic lavage in the previous 1 year, - patients who were receiving immunosuppressive, - patients with current use of anticoagulant medications, - NSAIDs used in the 5 days before blood donation, - major axis deviation (more than 15 degree of varus or more than 5 degree of valgus deviation), - patients with a hemoglobin level less than 11.5 g/dL, - platelets level less than 100,000/μL, - associated comorbidities, infection, tumor, crystal arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy. |
Hasil
Ukuran Hasil Utama
1. VAS [Baseline VAS score]
2. VAS [VAS score at 1st months]
3. VAS [VAS score at 3th months]
4. VAS [VAS score at 6th months]
5. VAS [VAS score at 12th months]
6. VAS [VAS score at 24th months]
7. KOOS [Baseline KOOS score]
8. KOOS [KOOS score at 1st months]
9. KOOS [KOOS score at 3th months]
10. KOOS [KOOS score at 6th months]
11. KOOS [KOOS score at 12th months]
12. KOOS [KOOS score at 24th months]
13. WOMAC [Baseline WOMAC score]
14. WOMAC [WOMAC score at 1st months]
15. WOMAC [WOMAC score at 3th months]
16. WOMAC [WOMAC score at 6th months]
17. WOMAC [WOMAC score at 12th months]
18. WOMAC [WOMAC score at 24th months]
19. Kujala [Baseline Kujala score]
20. Kujala [Kujala score at 1st months]
21. Kujala [Kujala score at 3th months]
22. Kujala [Kujala score at 6th months]
23. Kujala [Kujala score at 12th months]
24. Kujala [Kujala score at 24th months]
Ukuran Hasil Sekunder
1. Knee movement [1st, 3rd, 6th, 12th and 24th months]
2. knee circumference [1st, 3rd, 6th, 12th and 24th months]
3. mechanical axis angle [baseline]
4. age [baseline]
5. stage [baseline]
6. BMI [baseline]
7. patient global satisfaction [24 months]
