Degenerative Joint DiseasePhase 1NCT01920373
Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint
A Phase 1 study testing Group A (corticosteroid injection group) and Group B (platelet rich plasma injection group) in people with Degenerative Joint Disease, run by Kaiser Permanente at 1 site in United States.
Trial summary
1.0 BACKGROUND AND HYPOTHESES 1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in every joint. These include the replication of cells that produce matrix, enzymes, protease inhibitors, cytokines, and other peptides. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Degenerative Joint Disease
- What is being tested?
- Group A (corticosteroid injection group) and Group B (platelet rich plasma injection group)
- 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
- Nov 2013to Nov 2013
- Phase
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with systemic disorders such as rheumatic diseases, hematologic diseases, active infections, immunosuppression
- Patients receiving therapy with anticoagulants
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
About this study
Official title: Platelet-Rich Plasma Versus Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint
1.0 BACKGROUND AND HYPOTHESES
1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in every joint. These include the replication of cells that produce matrix, enzymes, protease inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a release of breakdown products into the synovial fluid. Enzymes and phagocytes are required to clear these breakdown products. Normal tissue turnover involves synthesis and breakdown in well-regulated balance. In the degenerative state this balance is upset producing inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone. Common causes of such alterations include increased loading, physical stress, and traumatic injury to the joint.
Read more
1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that they inhibit prostaglandin synthesis and decrease the activity of collagenase and other enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic agent that has several potential advantages over corticosteroids for the treatment of degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown to have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet rich plasma injections for treatment of knee cartilage degenerative lesions and osteoarthritis have shown longer efficacy than hyaluronic acid injections in reducing pain and recovering articular function. Similarly, platelet rich plasma has shown to have better outcomes than corticosteroid injections in the management of lateral epicondylitis, and better outcomes than hyaluronic acid injections in the management of osteochondral lesions of the talus.
1.3 Current treatments for degeneration and osteoarthritis of the temporomandibular joint are focused primarily on palliation by reducing inflammation and inflammatory mediators. This study seeks to validate a therapeutic agent that has the potential to actively prevent the progression of degeneration in addition to reducing pain and inflammation
Read the detailed description
2.0 OBJECTIVES AND PURPOSE
2.1 The purpose of this study is to compare the efficacy, in terms of pain relief and improvement in function, of intra-articular injections with platelet rich plasma versus the current standard which is corticosteroid injections into the temporomandibular joint.
- Conditions
- Degenerative Joint Disease
- Being tested
- Group A (corticosteroid injection group), Group B (platelet rich plasma injection group)
- Keywords
- degenerative joint disease, temporomandibular joint
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (corticosteroid injection group)Drug
Group B (platelet rich plasma injection group)Biological
| Study group | Role | What they receive |
|---|---|---|
| Group A (corticosteroid injection group) | Active comparator | Group A will receive one intra-articular injection of 2 ml of solution containing 1ml of 10mg/ml Triamcinolone suspended in 1 ml of 0.5% Bupivacaine solution per affected joint Receives: Drug: Group A (corticosteroid injection group) |
| Group B (platelet rich plasma injection) | Experimental | Group B will receive a 2 ml intra-articular injection of a platelet rich plasma preparation per affected joint Receives: Biological: Group B (platelet rich plasma injection group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Changes in pain relief will be evaluated at 1, 3, and six month intervals using the Pain resource centers TMJ scale.
Measured: 24 weeks
Secondary outcomes (1)
Improvement in function
The patients improvement in function will be evaluated at 1,3, and 6 months for improvement using the pain resource centers TMJ scale.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2013
Why it stopped: The study was cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Husam G Elias, MD, DMD, Principal investigator, Kaiser PermanenteJulian J Wilson, DDS, Study chair, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920373
- Sponsor's protocol ID
- 468485
- Status last verified
- Mar 2015
- First submitted
- 8 Aug 2013
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-Rich Plasma Versus Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint
- ClinicalTrials.gov ID
- NCT01920373
- Acronym / sponsor ID
- 468485
- Conditions
- Degenerative Joint Disease
- Keywords
- degenerative joint disease, temporomandibular joint
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (actual)
- First posted
- 12 Aug 2013 (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.
1.0 BACKGROUND AND HYPOTHESES
1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in every joint. These include the replication of cells that produce matrix, enzymes, protease inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a release of breakdown products into the synovial fluid. Enzymes and phagocytes are required to clear these breakdown products. Normal tissue turnover involves synthesis and breakdown in well-regulated balance. In the degenerative state this balance is upset producing inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone. Common causes of such alterations include increased loading, physical stress, and traumatic injury to the joint.
1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that they inhibit prostaglandin synthesis and decrease the activity of collagenase and other enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic agent that has several potential advantages over corticosteroids for the treatment of degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown to have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet rich plasma injections for treatment of knee cartilage degenerative lesions and osteoarthritis have shown longer efficacy than hyaluronic acid injections in reducing pain and recovering articular function. Similarly, platelet rich plasma has shown to have better outcomes than corticosteroid injections in the management of lateral epicondylitis, and better outcomes than hyaluronic acid injections in the management of osteochondral lesions of the talus.
1.3 Current treatments for degeneration and osteoarthritis of the temporomandibular joint are focused primarily on palliation by reducing inflammation and inflammatory mediators. This study seeks to validate a therapeutic agent that has the potential to actively prevent the progression of degeneration in addition to reducing pain and inflammation
Detailed description
2.0 OBJECTIVES AND PURPOSE
2.1 The purpose of this study is to compare the efficacy, in terms of pain relief and improvement in function, of intra-articular injections with platelet rich plasma versus the current standard which is corticosteroid injections into the temporomandibular joint.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (corticosteroid injection group) | Active comparator | Drug: Group A (corticosteroid injection group)Group A will receive one intra-articular injection of 2 ml of solution containing 1ml of 10mg/ml Triamcinolone suspended in 1 ml of 0.5% Bupivacaine solution per affected joint |
| Group B (platelet rich plasma injection) | Experimental | Biological: Group B (platelet rich plasma injection group)Group B will receive a 2 ml intra-articular injection of a platelet rich plasma preparation per affected joint |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients with systemic disorders such as rheumatic diseases, hematologic diseases, active infections, immunosuppression
- Patients receiving therapy with anticoagulants
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 |
|---|---|---|
| Group A (corticosteroid injection group) | Drug | Group A (corticosteroid injection group) |
| Group B (platelet rich plasma injection group) | Biological | Group B (platelet rich plasma injection) |
Primary outcome
Pain relief
Time frame: 24 weeks
Changes in pain relief will be evaluated at 1, 3, and six month intervals using the Pain resource centers TMJ scale.
1 secondary outcome
Improvement in function
Time frame: 24 weeks
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 11 Mar 2015.
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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.
Husam G Elias, MD, DMD principal investigator
Kaiser Permanente
Julian J Wilson, DDS study chair
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group A (corticosteroid injection group) and Group B (platelet rich plasma injection group) in people with Degenerative Joint Disease, run by Kaiser Permanente 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 0 inclusion and 2 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 11 Mar 2015. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pain relief (time frame: 24 weeks). 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 11 Mar 2015.