Knee OsteoarthritisPhase 4NCT04557943
Prolotherapy Intervention Effect in Patient With Knee Osteoarthritis
A Phase 4 study testing Prolotherapy and Sodium Hyaluronate in people with Knee Osteoarthritis, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
Introduction : Prolotherapy is regenerative tissue therapy which is considered to be efficacious in reducing symptoms and morbidity of Knee Osteoarthritis (KOA), but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Cartilage Oligomeric Matrix Protein… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Prolotherapy and Sodium Hyaluronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2019to 1 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient provides consent to be part of the research.
- The diagnosis of Knee Osteoarthritis was made based on clinical criteria/radiology American College of Rheumatology (ACR) 2012 with radiology grading according to Kellgren-Lawrence 2-3
Who cannot join
- The Patient has received other forms of intraarticular injection therapy.
- The patient has received Non Steroid Anti inflammation drug (NSAID) therapy for one week before the start of the intervention.
- The patient has one or more contraindications for prolotherapy (e.g., Abscess, cellulitis, or septic arthritis).
- Drop Out Criteria :
- The patient has undergone a strenuous physical activity that precipitates a degree of complication (i.e., joint effusion).
- The use of NSAID within one week after the intervention.
- The patient does not adhere to the intervention.
- The patient developed or being diagnosed with osteoarthritis or other forms of inflammatory disease in other joints.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Hasanuddin University, Faculty of Medicine
Makassar, South Sulawesi, 90245
About this study
Official title: The Level of Cartilage Oligomeric Matrix Protein (COMP) and Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II) After Prolotherapy Intervention and The Functional Outcome in Patient With Knee Osteoarthritis
Introduction :
Prolotherapy is regenerative tissue therapy which is considered to be efficacious in reducing symptoms and morbidity of Knee Osteoarthritis (KOA), but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Cartilage Oligomeric Matrix Protein (COMP), and Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II) as the biomarkers of cartilage repair.
Read more
Objective:
To determine the effect of prolotherapy on COMP and uCTX-II levels, and functional outcomes in KOA patients.
Method:
a double-blind randomized controlled trial study involving 36 participants who had been diagnosed with KOA. History taking, functional outcome assessment, COMP, and uCTX-II were measured. The prolotherapy via intraarticular and extraarticular was performed at Day-1, Day-29, and Day-57 followed by the evaluation of functional outcome, COMP, and uCTX-II at day 78
Alternative Hypothesis :
Prolotherapy provides improvement of cartilage based on COMP and UCTX-II levels and functional outcome among KOA patients
Read the detailed description
Design :
Double-blind randomized trial
Randomization :
Simple Randomization generated by an online randomizer
Sample Size :
Difference between two means of primary outcome where
- mean difference (μ 1 - μ 2 ) = 0.05
- pool variance = 0.09
- Z 1-α/2 = 1.95 with type 1 error 5%
- 1-β = 1.282 with power 90%. Yielding 16 patients for each arm
Time Period of Recruitment September 2019- August 2020
Detailed Intervention
- Intervention group : Prolotherapy given three times (Day-1, Day-29, and Day-57 )
- Comparison group : Hyaluronate given five times (Day-1, Day-8, Day-15, Day-22, and Day-29.)
Outcome Measurement :
- Cartilage Oligomeric Matrix Protein (COMP) Source of Sample : Median Cubital Vein Whole Blood Measurement : Enzyme-linked Immunoassay
- Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II) Source of Sample : 50 cc of random urine sample Measurement : Enzyme-linked Immunoassay
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional Outcome (self-reported assessment)
Domains :
- five elements of pain (score range 0-20),
- two for stiffness (score range 0-8),
- 17 for functional limitation (score range 0-68)
Classification :
0 - 24 : Mild 25 - 48 : Moderate 49 - 72 : Severe 73 - 96 : Extremely Severe
Statistical analysis :
- Descriptive statistic to elaborate baseline characteristic
- Assuming the baseline characteristic between groups are similar, the independent t-test will be conducted to see the differences between group, whereas Mann Whitney will be performed for non parametric data
- Difference within group (baseline and last day) will be measured by paired-t test or wilcoxon for non parametric scenario
- Conditions
- Knee Osteoarthritis
- Being tested
- Prolotherapy, Sodium Hyaluronate
- Keywords
- Knee Osteoarthritis, COMP, uCTX-II, Prolotherapy, Functional Outcome
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlotherapyDrug
Also called Prolotherapy Dextrose
Prolotherapy injection is performed intra-articularly and extra-articularly by a physician. Intra-articular injection with 25% dextrose will be carried out with the following details: 5 mL of 40% dextrose, 2 mL of lidocaine, and 1 mL of aqua dest are inserted into the 10-mL syringe, then 5 mL are injected with the superolateral approach. An extra-articular injection with 15% dextrose will be carried out with the following details:
in the 10-mL syringe 4 mL of 40% dextrose, 2 mL lidocaine, and 4 mL of distilled water are injected, to make a total of 30-40 mL injections. Treatment will be carried out on day 1st, 29th, and 57th.
Sodium HyaluronateDrug
Also called 2 mL Sodium Hyaluronate
Hyaluronan sodium injection is performed intra-articularly using 2 mL of Adant® Disposable. The treatment will be given five times, on day 1st, 8th, 15th, 22nd, and 29th
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hyaluronate | Active comparator | Hyaluronate sodium injection is performed intra-articularly using 2 mL of Adant® Disposable. The treatment will be given five times, on day 1st, 8th, 15th, 22nd, and 29th Receives: Drug: Sodium Hyaluronate |
| Prolotherapy | Experimental | Prolotherapy injection is performed intra-articularly and extra-articularly by a physician. Intra-articular injection with 25% dextrose will be carried out with the following details: 5 mL of 40% dextrose, 2 mL of lidocaine, and 1 mL of aqua dest are inserted into the 10-mL syringe, then 5 mL are injected with the superolateral approach. An extra-articular injection with 15% dextrose will be carried out with the following details:
in the 10-mL syringe 4 mL of 40% dextrose, 2 mL lidocaine, and 4 mL of distilled water are injected, to make a total of 30-40 mL injections. Treatment will be carried out on day 1st, 29th, and 57th. Receives: Drug: Prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cartilage Oligomeric Matrix Protein (COMP)
cartilage oligomeric matrix protein from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed
Measured: Measured on the first day before intervention and day 78 after the first dose of treatment in all groups
Secondary outcomes (2)
Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II)
Urinary C-Terminal Telopeptides of Type II Collagen from urine sample measured using Enzyme-linked Immunoassay (ELISA)
Measured: Measured on the first day before intervention and day 78 after the first injection on the prolotherapy group and Day 50 after the first injection for the hyaluronate group
Functional Outcome
the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index ) measuring three domains (pain, function limitation and stiffness) ranging from 0-96 of total score.
Measured: Measured on the first day before intervention and day 78 after the first injection on the prolotherapy group and Day 50 after the first injection for the hyaluronate group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Sep 2019
- Primary completion30 Apr 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study involves two arms assigned randomly for receiving different treatment. One arm for Prolotherapy and Sodium Hyaluronate in the comparison group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bumi Herman, Hasanuddin University
- Investigators
- Yose Waluyo, MD, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557943
- Sponsor's protocol ID
- 2708201904
- Status last verified
- Nov 2020
- First submitted
- 7 Sep 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rabago D, Zgierska A, Fortney L, Kijowski R, Mundt M, Ryan M, Grettie J, Patterson JJ. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14. doi: 10.1089/acm.2011.0030.
PubMed 22515800Eslamian F, Amouzandeh B. Therapeutic effects of prolotherapy with intra-articular dextrose injection in patients with moderate knee osteoarthritis: a single-arm study with 6 months follow up. Ther Adv Musculoskelet Dis. 2015 Apr;7(2):35-44. doi: 10.1177/1759720X14566618.
PubMed 25829954Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504.
PubMed 23690322Arias-Vazquez PI, Tovilla-Zarate CA, Legorreta-Ramirez BG, Burad Fonz W, Magana-Ricardez D, Gonzalez-Castro TB, Juarez-Rojop IE, Lopez-Narvaez ML. Prolotherapy for knee osteoarthritis using hypertonic dextrose vs other interventional treatments: systematic review of clinical trials. Adv Rheumatol. 2019 Aug 19;59(1):39. doi: 10.1186/s42358-019-0083-7.
PubMed 31426856Scarpellini M, Lurati A, Vignati G, Marrazza MG, Telese F, Re K, Bellistri A. Biomarkers, type II collagen, glucosamine and chondroitin sulfate in osteoarthritis follow-up: the "Magenta osteoarthritis study". J Orthop Traumatol. 2008 Jun;9(2):81-7. doi: 10.1007/s10195-008-0007-5. Epub 2008 May 28.
PubMed 19384621Garnero P, Conrozier T, Christgau S, Mathieu P, Delmas PD, Vignon E. Urinary type II collagen C-telopeptide levels are increased in patients with rapidly destructive hip osteoarthritis. Ann Rheum Dis. 2003 Oct;62(10):939-43. doi: 10.1136/ard.62.10.939.
PubMed 12972471Huang M, Zhao J, Huang Y, Dai L, Zhang X. Meta-analysis of urinary C-terminal telopeptide of type II collagen as a biomarker in osteoarthritis diagnosis. J Orthop Translat. 2017 Aug 15;13:50-57. doi: 10.1016/j.jot.2017.06.005. eCollection 2018 Apr.
PubMed 29662791Hoch JM, Mattacola CG, Medina McKeon JM, Howard JS, Lattermann C. Serum cartilage oligomeric matrix protein (sCOMP) is elevated in patients with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2011 Dec;19(12):1396-404. doi: 10.1016/j.joca.2011.09.005. Epub 2011 Oct 5.
PubMed 22001901Verma P, Dalal K. Serum cartilage oligomeric matrix protein (COMP) in knee osteoarthritis: a novel diagnostic and prognostic biomarker. J Orthop Res. 2013 Jul;31(7):999-1006. doi: 10.1002/jor.22324. Epub 2013 Feb 19.
PubMed 23423905Shewale AR, Barnes CL, Fischbach LA, Ounpraseuth ST, Painter JT, Martin BC. Comparison of Low-, Moderate-, and High-Molecular-Weight Hyaluronic Acid Injections in Delaying Time to Knee Surgery. J Arthroplasty. 2017 Oct;32(10):2952-2957.e21. doi: 10.1016/j.arth.2017.04.041. Epub 2017 May 2.
PubMed 28606459Topol GA, Podesta LA, Reeves KD, Giraldo MM, Johnson LL, Grasso R, Jamin A, Clark T, Rabago D. Chondrogenic Effect of Intra-articular Hypertonic-Dextrose (Prolotherapy) in Severe Knee Osteoarthritis. PM R. 2016 Nov;8(11):1072-1082. doi: 10.1016/j.pmrj.2016.03.008. Epub 2016 Apr 4.
PubMed 27058744Hung CY, Hsiao MY, Chang KV, Han DS, Wang TG. Comparative effectiveness of dextrose prolotherapy versus control injections and exercise in the management of osteoarthritis pain: a systematic review and meta-analysis. J Pain Res. 2016 Oct 18;9:847-857. doi: 10.2147/JPR.S118669. eCollection 2016.
PubMed 27799816
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Level of Cartilage Oligomeric Matrix Protein (COMP) and Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II) After Prolotherapy Intervention and The Functional Outcome in Patient With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04557943
- Acronym / sponsor ID
- 2708201904
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, COMP, uCTX-II, Prolotherapy, Functional Outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction :
Prolotherapy is regenerative tissue therapy which is considered to be efficacious in reducing symptoms and morbidity of Knee Osteoarthritis (KOA), but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Cartilage Oligomeric Matrix Protein (COMP), and Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II) as the biomarkers of cartilage repair.
Objective:
To determine the effect of prolotherapy on COMP and uCTX-II levels, and functional outcomes in KOA patients.
Method:
a double-blind randomized controlled trial study involving 36 participants who had been diagnosed with KOA. History taking, functional outcome assessment, COMP, and uCTX-II were measured. The prolotherapy via intraarticular and extraarticular was performed at Day-1, Day-29, and Day-57 followed by the evaluation of functional outcome, COMP, and uCTX-II at day 78
Alternative Hypothesis :
Prolotherapy provides improvement of cartilage based on COMP and UCTX-II levels and functional outcome among KOA patients
Detailed description
Design :
Double-blind randomized trial
Randomization :
Simple Randomization generated by an online randomizer
Sample Size :
Difference between two means of primary outcome where
- mean difference (μ 1 - μ 2 ) = 0.05
- pool variance = 0.09
- Z 1-α/2 = 1.95 with type 1 error 5%
- 1-β = 1.282 with power 90%. Yielding 16 patients for each arm
Time Period of Recruitment September 2019- August 2020
Detailed Intervention
- Intervention group : Prolotherapy given three times (Day-1, Day-29, and Day-57 )
- Comparison group : Hyaluronate given five times (Day-1, Day-8, Day-15, Day-22, and Day-29.)
Outcome Measurement :
- Cartilage Oligomeric Matrix Protein (COMP) Source of Sample : Median Cubital Vein Whole Blood Measurement : Enzyme-linked Immunoassay
- Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II) Source of Sample : 50 cc of random urine sample Measurement : Enzyme-linked Immunoassay
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional Outcome (self-reported assessment)
Domains :
- five elements of pain (score range 0-20),
- two for stiffness (score range 0-8),
- 17 for functional limitation (score range 0-68)
Classification :
0 - 24 : Mild 25 - 48 : Moderate 49 - 72 : Severe 73 - 96 : Extremely Severe
Statistical analysis :
- Descriptive statistic to elaborate baseline characteristic
- Assuming the baseline characteristic between groups are similar, the independent t-test will be conducted to see the differences between group, whereas Mann Whitney will be performed for non parametric data
- Difference within group (baseline and last day) will be measured by paired-t test or wilcoxon for non parametric scenario
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study involves two arms assigned randomly for receiving different treatment. One arm for Prolotherapy and Sodium Hyaluronate in the comparison group.
| Arm | Type | Receives |
|---|---|---|
| Sodium Hyaluronate | Active comparator | Drug: Sodium HyaluronateHyaluronate sodium injection is performed intra-articularly using 2 mL of Adant® Disposable. The treatment will be given five times, on day 1st, 8th, 15th, 22nd, and 29th |
| Prolotherapy | Experimental | Drug: ProlotherapyProlotherapy injection is performed intra-articularly and extra-articularly by a physician. Intra-articular injection with 25% dextrose will be carried out with the following details: 5 mL of 40% dextrose, 2 mL of lidocaine, and 1 mL of aqua dest are inserted into the 10-mL syringe, then 5 mL are injected with the superolateral approach. An extra-articular injection with 15% dextrose will be carried out with the following details: in the 10-mL syringe 4 mL of 40% dextrose, 2 mL lidocaine, and 4 mL of distilled water are injected, to make a total of 30-40 mL injections. Treatment will be carried out on day 1st, 29th, and 57th. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient provides consent to be part of the research.
- The diagnosis of Knee Osteoarthritis was made based on clinical criteria/radiology American College of Rheumatology (ACR) 2012 with radiology grading according to Kellgren-Lawrence 2-3
Key exclusion criteria (8 listed)
- The Patient has received other forms of intraarticular injection therapy.
- The patient has received Non Steroid Anti inflammation drug (NSAID) therapy for one week before the start of the intervention.
- The patient has one or more contraindications for prolotherapy (e.g., Abscess, cellulitis, or septic arthritis).
- The patient has undergone a strenuous physical activity that precipitates a degree of complication (i.e., joint effusion).
- The use of NSAID within one week after the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProlotherapyAlso: Prolotherapy DextroseProlotherapy injection is performed intra-articularly and extra-articularly by a physician. Intra-articular injection with 25% dextrose will be carried out with the following details: 5 mL of 40% dextrose, 2 mL of lidocaine, and 1 mL of aqua dest are inserted into the 10-mL syringe, then 5 mL are injected with the superolateral approach. An extra-articular injection with 15% dextrose will be carried out with the following details: in the 10-mL syringe 4 mL of 40% dextrose, 2 mL lidocaine, and 4 mL of distilled water are injected, to make a total of 30-40 mL injections. Treatment will be carried out on day 1st, 29th, and 57th. | Drug | Prolotherapy |
| Sodium HyaluronateAlso: 2 mL Sodium HyaluronateHyaluronan sodium injection is performed intra-articularly using 2 mL of Adant® Disposable. The treatment will be given five times, on day 1st, 8th, 15th, 22nd, and 29th | Drug | Sodium Hyaluronate |
Primary outcome
Cartilage Oligomeric Matrix Protein (COMP)
Time frame: Measured on the first day before intervention and day 78 after the first dose of treatment in all groups
cartilage oligomeric matrix protein from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed
2 secondary outcomes
Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II)
Time frame: Measured on the first day before intervention and day 78 after the first injection on the prolotherapy group and Day 50 after the first injection for the hyaluronate group
Functional Outcome
Time frame: Measured on the first day before intervention and day 78 after the first injection on the prolotherapy group and Day 50 after the first injection for the hyaluronate group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Background: PubMed 22515800Rabago D, Zgierska A, Fortney L, Kijowski R, Mundt M, Ryan M, Grettie J, Patterson JJ. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14. doi: 10.1089/acm.2011.0030.
- Background: PubMed 25829954Eslamian F, Amouzandeh B. Therapeutic effects of prolotherapy with intra-articular dextrose injection in patients with moderate knee osteoarthritis: a single-arm study with 6 months follow up. Ther Adv Musculoskelet Dis. 2015 Apr;7(2):35-44. doi: 10.1177/1759720X14566618.
- Background: PubMed 23690322Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504.
- Background: PubMed 31426856Arias-Vazquez PI, Tovilla-Zarate CA, Legorreta-Ramirez BG, Burad Fonz W, Magana-Ricardez D, Gonzalez-Castro TB, Juarez-Rojop IE, Lopez-Narvaez ML. Prolotherapy for knee osteoarthritis using hypertonic dextrose vs other interventional treatments: systematic review of clinical trials. Adv Rheumatol. 2019 Aug 19;59(1):39. doi: 10.1186/s42358-019-0083-7.
- Background: PubMed 19384621Scarpellini M, Lurati A, Vignati G, Marrazza MG, Telese F, Re K, Bellistri A. Biomarkers, type II collagen, glucosamine and chondroitin sulfate in osteoarthritis follow-up: the "Magenta osteoarthritis study". J Orthop Traumatol. 2008 Jun;9(2):81-7. doi: 10.1007/s10195-008-0007-5. Epub 2008 May 28.
- Background: PubMed 12972471Garnero P, Conrozier T, Christgau S, Mathieu P, Delmas PD, Vignon E. Urinary type II collagen C-telopeptide levels are increased in patients with rapidly destructive hip osteoarthritis. Ann Rheum Dis. 2003 Oct;62(10):939-43. doi: 10.1136/ard.62.10.939.
- Background: PubMed 29662791Huang M, Zhao J, Huang Y, Dai L, Zhang X. Meta-analysis of urinary C-terminal telopeptide of type II collagen as a biomarker in osteoarthritis diagnosis. J Orthop Translat. 2017 Aug 15;13:50-57. doi: 10.1016/j.jot.2017.06.005. eCollection 2018 Apr.
- Background: PubMed 22001901Hoch JM, Mattacola CG, Medina McKeon JM, Howard JS, Lattermann C. Serum cartilage oligomeric matrix protein (sCOMP) is elevated in patients with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2011 Dec;19(12):1396-404. doi: 10.1016/j.joca.2011.09.005. Epub 2011 Oct 5.
- Background: PubMed 23423905Verma P, Dalal K. Serum cartilage oligomeric matrix protein (COMP) in knee osteoarthritis: a novel diagnostic and prognostic biomarker. J Orthop Res. 2013 Jul;31(7):999-1006. doi: 10.1002/jor.22324. Epub 2013 Feb 19.
- Background: PubMed 28606459Shewale AR, Barnes CL, Fischbach LA, Ounpraseuth ST, Painter JT, Martin BC. Comparison of Low-, Moderate-, and High-Molecular-Weight Hyaluronic Acid Injections in Delaying Time to Knee Surgery. J Arthroplasty. 2017 Oct;32(10):2952-2957.e21. doi: 10.1016/j.arth.2017.04.041. Epub 2017 May 2.
- Background: PubMed 27058744Topol GA, Podesta LA, Reeves KD, Giraldo MM, Johnson LL, Grasso R, Jamin A, Clark T, Rabago D. Chondrogenic Effect of Intra-articular Hypertonic-Dextrose (Prolotherapy) in Severe Knee Osteoarthritis. PM R. 2016 Nov;8(11):1072-1082. doi: 10.1016/j.pmrj.2016.03.008. Epub 2016 Apr 4.
- Background: PubMed 27799816Hung CY, Hsiao MY, Chang KV, Han DS, Wang TG. Comparative effectiveness of dextrose prolotherapy versus control injections and exercise in the management of osteoarthritis pain: a systematic review and meta-analysis. J Pain Res. 2016 Oct 18;9:847-857. doi: 10.2147/JPR.S118669. eCollection 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yose Waluyo, MD principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prolotherapy and Sodium Hyaluronate in people with Knee Osteoarthritis, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cartilage Oligomeric Matrix Protein (COMP) (time frame: Measured on the first day before intervention and day 78 after the first dose of treatment in all groups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04557943, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.