Knee OsteoarthritisNCT06631456
Effects of Platelet-Rich Plasma and Ozone Therapy in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Knee osteoarthritis can frequently occur with advancing age. In cases of pain that persists despite hot/cold applications, drug therapy and exercise, intra-articular injections are considered. In advanced-stage gonarthrosis, steroid injections may respond. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PRP injection and Ozone therapy
- Type of treatment
- Injection or infusion
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Oct 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Stage 2-3 gonarthrosis according to KL who apply to our hospital\'s Physical Medicine and Rehabilitation out-patient clinic will be included.
Who may be able to join
- 30-70 years old, Stage 2-3 gonarthrosis according to KL
- Voluntariness to participate in the study
Who cannot join
- Cognitive dysfunction
- General medical condition is not suitable for injections and evaluations
- History of knee injections in the last 3 months
- History of previous knee surgery
- Bleeding disorders or those taking medications that may cause bleeding disorders after injections
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital, İstanbul
Istanbul
About this study
Official title: Effects of Platelet-Rich Plasma and Ozone Therapy on Pain and Quality of Life in Knee Osteoarthritis: A Retrospective Study
Knee osteoarthritis can frequently occur with advancing age. In cases of pain that persists despite hot/cold applications, drug therapy and exercise, intra-articular injections are considered. In advanced-stage gonarthrosis, steroid injections may respond. However, in mild and moderate knee arthritis, regenerative methods come to the forefront because the joint cartilage is still partially/completely intact. PRP and ozone therapy are frequently applied intra-articular treatments. This study will compare the effects of both injection methods on clinical outcomes.
Read the detailed description
Knee osteoarthritis is a common arthrosis that can be encountered frequently with increasing life expectancy. In mild-moderate stages, hot/cold applications, drug treatments and exercise applications are usually applied, while in those who do not respond, physical therapy or intra-articular injection treatments are applied. This retrospective study aims to examine the effects of intra-articular Platelet Rich Plasma (PRP) and ozone therapy on pain, functionality and quality of life in patients with Stage 2-3 gonarthrosis according to the Kelgren-Lawrence (KL) Classification.
- Conditions
- Knee Osteoarthritis
- Being tested
- PRP injection, Ozone therapy
- Keywords
- knee osteoarthritis, platelet rich plasma, ozone therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionOther
A total of 3 doses of intra-articular PRP were applied to the symptomatic knees of the patients under ultrasound guidance, once a week.
Ozone therapyOther
A total of 3 doses of intra-articular ozone therapy were applied to the symptomatic knees of the patients under ultrasound guidance, once a week.
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Patients who received intra-articular PRP due to gonarthrosis Receives: Other: PRP injection | |
| Ozone group | Patients who received intra-articular ozone therapy due to gonarthrosis Receives: Other: Ozone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-Numerical Rating Scale
Pain level will be evaluated with the Numerical Rating Scale. (minimum: 0, maximum: 10)
Measured: From enrollment to the end of treatment at 3rd month
Secondary outcomes (2)
Pain, stiffness and physical function-WOMAC
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each sub-scale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three sub-scales gives a total WOMAC score.
Measured: From enrollment to the end of treatment at 3rd month
Quality of life-SF-12
The 12-item short-form health survey (SF-12) quality of life scale was used to evaluate general quality of life. It was presented as a physical component score (PCS) and mental component score (MCS). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: From enrollment to the end of treatment at 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Aug 2024
- Primary completion30 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 54 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Çiftci, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Banu Kuran, Professor, Study director, Şişli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631456
- Sponsor's protocol ID
- 09/07/2024-4460
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Platelet-Rich Plasma and Ozone Therapy on Pain and Quality of Life in Knee Osteoarthritis: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06631456
- Acronym / sponsor ID
- 09/07/2024-4460
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, platelet rich plasma, ozone therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 8 Oct 2024 (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.
Knee osteoarthritis can frequently occur with advancing age. In cases of pain that persists despite hot/cold applications, drug therapy and exercise, intra-articular injections are considered. In advanced-stage gonarthrosis, steroid injections may respond. However, in mild and moderate knee arthritis, regenerative methods come to the forefront because the joint cartilage is still partially/completely intact. PRP and ozone therapy are frequently applied intra-articular treatments. This study will compare the effects of both injection methods on clinical outcomes.
Detailed description
Knee osteoarthritis is a common arthrosis that can be encountered frequently with increasing life expectancy. In mild-moderate stages, hot/cold applications, drug treatments and exercise applications are usually applied, while in those who do not respond, physical therapy or intra-articular injection treatments are applied. This retrospective study aims to examine the effects of intra-articular Platelet Rich Plasma (PRP) and ozone therapy on pain, functionality and quality of life in patients with Stage 2-3 gonarthrosis according to the Kelgren-Lawrence (KL) Classification.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | – | Other: PRP injectionPatients who received intra-articular PRP due to gonarthrosis |
| Ozone group | – | Other: Ozone therapyPatients who received intra-articular ozone therapy due to gonarthrosis |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Stage 2-3 gonarthrosis according to KL who apply to our hospital\'s Physical Medicine and Rehabilitation out-patient clinic will be included.
Key inclusion criteria (2 listed)
- 30-70 years old, Stage 2-3 gonarthrosis according to KL
- Voluntariness to participate in the study
Key exclusion criteria (5 listed)
- Cognitive dysfunction
- General medical condition is not suitable for injections and evaluations
- History of knee injections in the last 3 months
- History of previous knee surgery
- Bleeding disorders or those taking medications that may cause bleeding disorders after injections
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 |
|---|---|---|
| PRP injectionA total of 3 doses of intra-articular PRP were applied to the symptomatic knees of the patients under ultrasound guidance, once a week. | Other | PRP group |
| Ozone therapyA total of 3 doses of intra-articular ozone therapy were applied to the symptomatic knees of the patients under ultrasound guidance, once a week. | Other | Ozone group |
Primary outcome
Pain-Numerical Rating Scale
Time frame: From enrollment to the end of treatment at 3rd month
Pain level will be evaluated with the Numerical Rating Scale. (minimum: 0, maximum: 10)
2 secondary outcomes
Pain, stiffness and physical function-WOMAC
Time frame: From enrollment to the end of treatment at 3rd month
Quality of life-SF-12
Time frame: From enrollment to the end of treatment at 3rd month
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 8 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Banu Kuran, Professor study director
Şişli Hamidiye Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 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 8 Oct 2024. 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 Turkey (Türkiye). 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.
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?
Pain-Numerical Rating Scale (time frame: From enrollment to the end of treatment at 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2024.