Knee OsteoarthritisPhase 4NCT02176304
Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes.
A Phase 4 study testing Depomedrol and Lidocaine in people with Knee Osteoarthritis, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
Knee osteoarthritis is one of the most prevalent orthopedic conditions worldwide. With the aging population, a 40% patient increase is expected to present at clinics with complaints of primary osteoarthritis by 2025. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Depomedrol and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Jun 2014to Dec 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria include Early osteoarthritis as per Brandt grades, persistent joint pain warranting a clinic visit, no previous injections given, significant pain in visual analog scale, failure of exercise and oral analgesics.
Who cannot join
- Exclusion criteria include advanced knee osteoarthritis, patients with bloody effusions, the use of warfarin or antiplatelet therapy, presence of any infection, patients with arthritis other than primary osteoarthritis, patients younger than age 25 due to low likelihood of primary arthritis, pregnant females, diabetics with poor glucose control, and patients that have previously been injected in knee(s).
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Rico School Of Medicine Outpatient Clinics
San Juan, 00918
About this study
Knee osteoarthritis is one of the most prevalent orthopedic conditions worldwide. With the aging population, a 40% patient increase is expected to present at clinics with complaints of primary osteoarthritis by 2025. Multiple studies have attempted to establish non-surgical criteria for knee arthritis and usage of resources to avoid major surgery. It has long been accepted as a treatment option for patients who have failed to respond to NSAIDs and other non-surgical therapies to receive intra-articular injections of steroid and anesthesia mixtures to hold off disease progression.
Various studies have compared different sites of injection and the accuracy rate of the injection being within the joint. Recent studies report a 66% accuracy on palpation-guided injection on the anterolateral knee, 93% accuracy on palpation-guided injection on the superolateral portal of the knee, and new studies show an improvement of up to 98% with use of ultrasound guiding software. However, in a health care system with limited resources, providing patients with US-guided injections represented an increased cost of $178.35 per patient as per 2010 Medicare reports.
Read more
Therefore, assuming these accuracy rates, we will compare the anterolateral and superolateral portals for knee injection and their clinical effect to monitor if in fact there is a difference in patient reported outcomes. As a secondary analysis, if no difference is found, a strong case for palpation-guided injections versus ultrasound-guided injections can be made.
In this study we will prospectively enroll 60 patients to be divided into two 30 patient groups with primary knee osteoarthritis. Patients that qualify as subjects will be treated with an intraarticular knee injection through an anterolateral portal or a suprapatellar portal as per group in which they are placed. Scores will be given for pain of the injection and of the baseline illness and compared on a subsequent visit to assess self-reported functional outcomes.
- Conditions
- Knee Osteoarthritis
- Being tested
- Depomedrol, Lidocaine
- Keywords
- knee, arthritis, injections, corticosteroids
- Medical subject headings
- Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepomedrolDrug
Also called Depomedrol 40 mg/ml
Depomedrol 40 mg/ml, 1 ml injected to knee on day one of intervention.
LidocaineDrug
Also called Lidocaine 2%
Lidocaine 2% soln, 4 ml injected to knee on day 1 of intervention
| Study group | Role | What they receive |
|---|---|---|
| Suprapatellar Knee Injection Site | Active comparator | Patients will be injected specified dose of lidocaine and depomedrol through suprapatellar-lateral knee entry site. Receives: Drug: Depomedrol; Drug: Lidocaine |
| Anterolateral knee injection | Active comparator | Patients will be injected specified dose of lidocaine and depomedrol through anterolateral knee entry site. Receives: Drug: Depomedrol; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Term Pain improvement
Measured: 1 week
Medium Term Pain Improvement
Measured: 1 month
Self Reported Patient Scores Improvement
WOMAC and Visual Analog Scale will be used to monitor improvement
Measured: 1 month
Secondary outcomes (1)
Pain on injection site
Will compare pain on site of injection on study arms.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionDec 2014
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariel D. Davila Parrilla, MD, University of Puerto Rico
- Investigators
- Ariel D Davila-Parrilla, MD, Principal investigator, University of Puerto Rico Orthopedics DepartmentAntonio Otero-Lopez, MD, Study director, University of Puerto Rico Orthopedics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176304
- Sponsor's protocol ID
- Knee Injections
- Status last verified
- May 2017
- First submitted
- 25 Jun 2014
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes.
- ClinicalTrials.gov ID
- NCT02176304
- Acronym / sponsor ID
- Knee Injections
- Conditions
- Knee Osteoarthritis
- Keywords
- knee, arthritis, injections, corticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Jun 2014 (estimated)
- 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 is one of the most prevalent orthopedic conditions worldwide. With the aging population, a 40% patient increase is expected to present at clinics with complaints of primary osteoarthritis by 2025. Multiple studies have attempted to establish non-surgical criteria for knee arthritis and usage of resources to avoid major surgery. It has long been accepted as a treatment option for patients who have failed to respond to NSAIDs and other non-surgical therapies to receive intra-articular injections of steroid and anesthesia mixtures to hold off disease progression.
Various studies have compared different sites of injection and the accuracy rate of the injection being within the joint. Recent studies report a 66% accuracy on palpation-guided injection on the anterolateral knee, 93% accuracy on palpation-guided injection on the superolateral portal of the knee, and new studies show an improvement of up to 98% with use of ultrasound guiding software. However, in a health care system with limited resources, providing patients with US-guided injections represented an increased cost of $178.35 per patient as per 2010 Medicare reports.
Therefore, assuming these accuracy rates, we will compare the anterolateral and superolateral portals for knee injection and their clinical effect to monitor if in fact there is a difference in patient reported outcomes. As a secondary analysis, if no difference is found, a strong case for palpation-guided injections versus ultrasound-guided injections can be made.
In this study we will prospectively enroll 60 patients to be divided into two 30 patient groups with primary knee osteoarthritis. Patients that qualify as subjects will be treated with an intraarticular knee injection through an anterolateral portal or a suprapatellar portal as per group in which they are placed. Scores will be given for pain of the injection and of the baseline illness and compared on a subsequent visit to assess self-reported functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprapatellar Knee Injection Site | Active comparator | Drug: Depomedrol, Drug: LidocainePatients will be injected specified dose of lidocaine and depomedrol through suprapatellar-lateral knee entry site. |
| Anterolateral knee injection | Active comparator | Drug: Depomedrol, Drug: LidocainePatients will be injected specified dose of lidocaine and depomedrol through anterolateral knee entry site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria include Early osteoarthritis as per Brandt grades, persistent joint pain warranting a clinic visit, no previous injections given, significant pain in visual analog scale, failure of exercise and oral analgesics.
Key exclusion criteria (1 listed)
- Exclusion criteria include advanced knee osteoarthritis, patients with bloody effusions, the use of warfarin or antiplatelet therapy, presence of any infection, patients with arthritis other than primary osteoarthritis, patients younger than age 25 due to low likelihood of primary arthritis, pregnant females, diabetics with poor glucose control, and patients that have previously been injected in knee(s).
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 |
|---|---|---|
| DepomedrolAlso: Depomedrol 40 mg/mlDepomedrol 40 mg/ml, 1 ml injected to knee on day one of intervention. | Drug | Anterolateral knee injection, Suprapatellar Knee Injection Site |
| LidocaineAlso: Lidocaine 2%Lidocaine 2% soln, 4 ml injected to knee on day 1 of intervention | Drug | Anterolateral knee injection, Suprapatellar Knee Injection Site |
Primary outcome
Short Term Pain improvement
Time frame: 1 week
Medium Term Pain Improvement
Time frame: 1 month
Self Reported Patient Scores Improvement
Time frame: 1 month
WOMAC and Visual Analog Scale will be used to monitor improvement
1 secondary outcome
Pain on injection site
Time frame: baseline
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 1 Jun 2017.
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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.
Ariel D Davila-Parrilla, MD principal investigator
University of Puerto Rico Orthopedics Department
Antonio Otero-Lopez, MD study director
University of Puerto Rico Orthopedics Department
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 Depomedrol and Lidocaine in people with Knee Osteoarthritis, run by University of Puerto Rico at 1 site in Puerto Rico.
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 1 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 1 Jun 2017. 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 Puerto Rico. 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?
Short Term Pain improvement (time frame: 1 week). The study lists 3 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 1 Jun 2017.