Osteoarthritis, KneeIPACKNCT06712394
Knee Osteoarthritis and IPACK
An observational study of Osteoarthritis, Knee, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- IPACK
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 10 Jun 2026
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 50-90 who underwent IPACK block treatment due to Knee OA
Who may be able to join
- Patients suffering from grade 3 and 4 knee osteoarthritis
Who cannot join
- Patients who have had previous knee surgery
- Patients who have had any knee injection in the last 3 months
- Malignancy
- Inflammatory disease
- Infectious disease (local or general)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interspace Between the Popliteal Artery and Capsule of the Posterior Knee-
Interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule.
The purpose of the study; To investigate the effectiveness of this block applied to knee osteoarthritis in clinical practice.
In this study, patients who underwent IPACK block by the practitioner; Demographic data, medications used, block success, block characteristics and block-related complications will be recorded observationally. Before and after the block procedure, patients' pain was measured with the Numeric Rating Scale (NRS) at 1st and 3rd months, their disability levels were measured with The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire and Short Form-12 (Short Form). Quality of life will be measured with the -SF-12) survey.
- Conditions
- Osteoarthritis, Knee
- Being tested
- IPACK
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPACKProcedure or surgery
The IPACK block involves infiltration of the space between the popliteal artery and the posterior knee joint capsule with 20 ml of 0.25% local anesthetic (bupivacain) under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| IPACK | IPACK block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule. Receives: Procedure: IPACK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
The Numeric Rating Scale (NRS) is a frequently used tool for assessing and monitoring the severity of pain. The pain scale measures on an 11-point rating system, where 0 indicates the absence of pain and 10 represents the most severe pain one can imagine. Patients are requested to assess their pain on a scale ranging from 0 to 10. The physician obtained from measurements at each visit by directly questioning the patient.
Measured: 1st and 3rd month after the procedure
Functional status
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The questionnaire evaluates activities of daily living and functional mobility. 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 subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 1st and 3rd month after the procedure
Secondary outcomes (1)
Quality of life assessment
The assessment of quality of life was conducted using the SF-12, a questionnaire specifically designed to measure health-related quality of life. The SF-12 consists of twelve items that evaluate eight different health domains, providing an evaluation of both physical and mental well-being. The SF-12 provides two summary scores: the mental component score (MCS-12) and the physical component score (PCS-12). A decrease in the questionnaire score indicates progression of disability. The questionnaire's validity and reliability were ensured, and the Turkish version of the questionnaire was filled out by the patients.
Measured: 1st and 3rd month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start2 Jan 2025
- Primary completion15 May 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rıdvan Isık, Study chair, sakarya training and research hospital, pain clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712394
- Sponsor's protocol ID
- isik eman ipack
- Acronym
- IPACK
- Status last verified
- Jul 2026
- First submitted
- 3 Sep 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interspace Between the Popliteal Artery and Capsule of the Posterior Knee-
- ClinicalTrials.gov ID
- NCT06712394
- Acronym / sponsor ID
- IPACK / isik eman ipack
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 2 Dec 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.
Interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule.
The purpose of the study; To investigate the effectiveness of this block applied to knee osteoarthritis in clinical practice.
In this study, patients who underwent IPACK block by the practitioner; Demographic data, medications used, block success, block characteristics and block-related complications will be recorded observationally. Before and after the block procedure, patients' pain was measured with the Numeric Rating Scale (NRS) at 1st and 3rd months, their disability levels were measured with The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire and Short Form-12 (Short Form). Quality of life will be measured with the -SF-12) survey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPACK | – | Procedure: IPACKIPACK block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 50-90 who underwent IPACK block treatment due to Knee OA
Key inclusion criteria (1 listed)
- Patients suffering from grade 3 and 4 knee osteoarthritis
Key exclusion criteria (5 listed)
- Patients who have had previous knee surgery
- Patients who have had any knee injection in the last 3 months
- Malignancy
- Inflammatory disease
- Infectious disease (local or general)
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 |
|---|---|---|
| IPACKThe IPACK block involves infiltration of the space between the popliteal artery and the posterior knee joint capsule with 20 ml of 0.25% local anesthetic (bupivacain) under ultrasound guidance. | Procedure or surgery | IPACK |
Primary outcome
Pain assessment
Time frame: 1st and 3rd month after the procedure
The Numeric Rating Scale (NRS) is a frequently used tool for assessing and monitoring the severity of pain. The pain scale measures on an 11-point rating system, where 0 indicates the absence of pain and 10 represents the most severe pain one can imagine. Patients are requested to assess their pain on a scale ranging from 0 to 10. The physician obtained from measurements at each visit by directly questioning the patient.
Functional status
Time frame: 1st and 3rd month after the procedure
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The questionnaire evaluates activities of daily living and functional mobility. 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 subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
1 secondary outcome
Quality of life assessment
Time frame: 1st and 3rd month after the procedure
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 6 Jul 2026.
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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.
Rıdvan Isık study chair
sakarya training and research hospital, pain clinic
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 Osteoarthritis, Knee, run by Sakarya University 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 1 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 6 Jul 2026. 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 assessment (time frame: 1st and 3rd month after the procedure). The study lists 2 primary outcomes in all. 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 6 Jul 2026.