Knee Pain ChronicEarly Phase 1NCT03225092
Platelet-rich Plasma Injections for Persistent Medial Knee Pain After Total Knee Arthroplasty
A Early Phase 1 study testing Ultrasound-guided platelet rich plasma injection in people with Knee Pain Chronic and Pes Anserinus Bursitis, run by Ohio State University at 1 site in United States.
Trial summary
This study will investigate the potential effects of platelet rich plasma for the treatment of persistent medial knee pain after total knee arthroplasty. All study participants will receive PRP injections and will be followed up to see if any benefit in regards to pain and/or function is achieved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Pain Chronic, Pes Anserinus Bursitis, Status-Post Total Knee Arthroplasty
- What is being tested?
- Ultrasound-guided platelet rich plasma injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2017to 30 Jun 2019
- Phase
- Early Phase 1
- 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
- Person has had a total knee arthroplasty (total knee replacement)
- Has experienced persistent medial knee pain beyond six months after surgery
- Has the presumed diagnosis of pes anserine bursitis
- No pain relief with conventional treatments such as arch supports (if one is flatfooted), NSAID's, and at least two local steroid injections
Who cannot join
- Person has had a prior knee surgical procedure other than the total knee arthroplasty or an arthroscopic debridement procedure
- Evidence of knee instability, prosthetic loosening, knee infection, radiculopathy, or hip or back pain
- Personal history of chronic narcotic or recreational drug use, smoking, psychiatric disorders, or a total hip arthroplasty on the same side of the knee arthroplasty
- Body mass index (BMI) of greater than 35
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43202
About this study
Official title: Efficacy of Platelet-rich Plasma Injections for the Treatment of Persistent Medial Knee Pain After Total Knee Arthroplasty
This study will investigate the potential effects of platelet rich plasma for the treatment of persistent medial knee pain after total knee arthroplasty. All study participants will receive PRP injections and will be followed up to see if any benefit in regards to pain and/or function is achieved.
Read the detailed description
This study aims to investigate the efficacy of platelet-rich plasma (PRP) injections for the treatment of persistent medial knee pain after total knee arthroplasty (TKA). The investigators hypothesize that PRP injections will provide meaningful pain relief and improved functionality for patients suffering from post-TKA residual pain. The incidence of residual pain after TKA ranges between 10-34%. Many of these patients can be effectively managed by physical therapy, orthotics, and pes anserine bursa corticosteroid injections. However, there remain a number of refractory cases that are frustrating for both the patient and physician. With the advent of interventional pain management, advanced interventions for this clinical problem have focused on selective nerve blocks and ablations targeting the infrapatellar branch of the saphenous nerve. More recently, attention has been paid to the role of patient biology and inflammatory mediators in the development of post-arthroplasty pain (including IL-6 and CRP). If individual patient biology is the foundation of post-TKA pain, then biologic interventions aimed at restoring the balance of these mediators (such as PRP), rather than ablative procedures, seems preferable. Furthermore, while intra-operative PRP has been studied for its effects on wound healing, blood loss, and post-operative pain control, no study has investigated its utility in treating residual medial knee pain after TKA.
All injections will be performed by the same board-certified sports medicine and musculoskeletal ultrasound physician. There will be no activity restrictions following the procedure.
Descriptive statistics will be used to report mean changes in outcome scores. Data will be analyzed with a 2-sample t-test.
- Being tested
- Ultrasound-guided platelet rich plasma injection
- Keywords
- Chronic Knee Pain, Status-Post Total Knee Arthroplasty, Platelet Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided platelet rich plasma injectionBiological
Each participant will receive a single injection into the pes anserine bursa (using the Arthrex Angel system with a setting of 180cc of peripheral blood and 1% hematocrit concentration) under sterile technique
| Study group | Role | What they receive |
|---|---|---|
| PRP Injection | Experimental | Ultrasound-guided platelet rich plasma injection Receives: Biological: Ultrasound-guided platelet rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Knee Society Scores, a score measurement created by The Knee Society, will be collected as below.
Measured: Change from baseline to 6 months is primary outcome. Additional outcomes will be collected at 1 and 3 months after procedure.
Secondary outcomes (2)
The Hospital for Special Surgery (HSS) Knee Score
Knee Scores, a score measurement created by The Hospital for Special Surgery, will be collected as below.
Measured: Recorded as a baseline and then at 1, 3, and 6 months post intervention
Visual Analog Scale (VAS) for Pain
A patient-reported measurement where the subjects will rate their knee pain level by placing a mark along a 100 millimeter line (with each millimeter corresponding to a number, from 0 to 100, 0 meaning no pain at all and 100 meaning the worst pain possible).
Measured: Recorded as a baseline and then at 1, 3, and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start18 Jul 2017 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Why it stopped: Unable to recruit enough study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Observational pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Baria, Ohio State University
- Investigators
- Michael Baria, MD, MBA, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225092
- Sponsor's protocol ID
- 2017H0153
- Status last verified
- Apr 2020
- First submitted
- 18 Jul 2017
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.
PubMed 22357571Shi SM, Meister DW, Graner KC, Ninomiya JT. Selective Denervation for Persistent Knee Pain After Total Knee Arthroplasty: A Report of 50 Cases. J Arthroplasty. 2017 Mar;32(3):968-973. doi: 10.1016/j.arth.2016.09.043. Epub 2016 Oct 8.
PubMed 27817995Preston S, Petrera M, Kim C, Zywiel MG, Gandhi R. Towards an understanding of the painful total knee: what is the role of patient biology? Curr Rev Musculoskelet Med. 2016 Dec;9(4):388-395. doi: 10.1007/s12178-016-9363-6.
PubMed 27613710
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-rich Plasma Injections for the Treatment of Persistent Medial Knee Pain After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03225092
- Acronym / sponsor ID
- 2017H0153
- Keywords
- Chronic Knee Pain, Status-Post Total Knee Arthroplasty, Platelet Rich Plasma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit enough study participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 18 Jul 2017 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 21 Jul 2017 (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.
This study will investigate the potential effects of platelet rich plasma for the treatment of persistent medial knee pain after total knee arthroplasty. All study participants will receive PRP injections and will be followed up to see if any benefit in regards to pain and/or function is achieved.
Detailed description
This study aims to investigate the efficacy of platelet-rich plasma (PRP) injections for the treatment of persistent medial knee pain after total knee arthroplasty (TKA). The investigators hypothesize that PRP injections will provide meaningful pain relief and improved functionality for patients suffering from post-TKA residual pain. The incidence of residual pain after TKA ranges between 10-34%. Many of these patients can be effectively managed by physical therapy, orthotics, and pes anserine bursa corticosteroid injections. However, there remain a number of refractory cases that are frustrating for both the patient and physician. With the advent of interventional pain management, advanced interventions for this clinical problem have focused on selective nerve blocks and ablations targeting the infrapatellar branch of the saphenous nerve. More recently, attention has been paid to the role of patient biology and inflammatory mediators in the development of post-arthroplasty pain (including IL-6 and CRP). If individual patient biology is the foundation of post-TKA pain, then biologic interventions aimed at restoring the balance of these mediators (such as PRP), rather than ablative procedures, seems preferable. Furthermore, while intra-operative PRP has been studied for its effects on wound healing, blood loss, and post-operative pain control, no study has investigated its utility in treating residual medial knee pain after TKA.
All injections will be performed by the same board-certified sports medicine and musculoskeletal ultrasound physician. There will be no activity restrictions following the procedure.
Descriptive statistics will be used to report mean changes in outcome scores. Data will be analyzed with a 2-sample t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observational pilot study
| Arm | Type | Receives |
|---|---|---|
| PRP Injection | Experimental | Biological: Ultrasound-guided platelet rich plasma injectionUltrasound-guided platelet rich plasma injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Person has had a total knee arthroplasty (total knee replacement)
- Has experienced persistent medial knee pain beyond six months after surgery
- Has the presumed diagnosis of pes anserine bursitis
- No pain relief with conventional treatments such as arch supports (if one is flatfooted), NSAID's, and at least two local steroid injections
Key exclusion criteria (4 listed)
- Person has had a prior knee surgical procedure other than the total knee arthroplasty or an arthroscopic debridement procedure
- Evidence of knee instability, prosthetic loosening, knee infection, radiculopathy, or hip or back pain
- Personal history of chronic narcotic or recreational drug use, smoking, psychiatric disorders, or a total hip arthroplasty on the same side of the knee arthroplasty
- Body mass index (BMI) of greater than 35
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 |
|---|---|---|
| Ultrasound-guided platelet rich plasma injectionEach participant will receive a single injection into the pes anserine bursa (using the Arthrex Angel system with a setting of 180cc of peripheral blood and 1% hematocrit concentration) under sterile technique | Biological | PRP Injection |
Primary outcome
Knee Society Score
Time frame: Change from baseline to 6 months is primary outcome. Additional outcomes will be collected at 1 and 3 months after procedure.
Knee Society Scores, a score measurement created by The Knee Society, will be collected as below.
2 secondary outcomes
The Hospital for Special Surgery (HSS) Knee Score
Time frame: Recorded as a baseline and then at 1, 3, and 6 months post intervention
Visual Analog Scale (VAS) for Pain
Time frame: Recorded as a baseline and then at 1, 3, and 6 months post intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Background: PubMed 22357571Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.
- Background: PubMed 27817995Shi SM, Meister DW, Graner KC, Ninomiya JT. Selective Denervation for Persistent Knee Pain After Total Knee Arthroplasty: A Report of 50 Cases. J Arthroplasty. 2017 Mar;32(3):968-973. doi: 10.1016/j.arth.2016.09.043. Epub 2016 Oct 8.
- Background: PubMed 27613710Preston S, Petrera M, Kim C, Zywiel MG, Gandhi R. Towards an understanding of the painful total knee: what is the role of patient biology? Curr Rev Musculoskelet Med. 2016 Dec;9(4):388-395. doi: 10.1007/s12178-016-9363-6.
- Individual participant dataSharing planned: Undecided
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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.
Michael Baria, MD, MBA principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ultrasound-guided platelet rich plasma injection in people with Knee Pain Chronic and Pes Anserinus Bursitis, run by Ohio State University at 1 site in United States.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 17 Apr 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Knee Society Score (time frame: Change from baseline to 6 months is primary outcome. Additional outcomes will be collected at 1 and 3 months after procedure.). 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 NCT03225092, which also lists 3 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 17 Apr 2020.