Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint

NCT01920373 | Withdrawn Phase 1 DMC

• 1 other identifier: 468485
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Degenerative Joint Disease

Keywords

degenerative joint disease; temporomandibular joint

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Changes in pain relief will be evaluated at 1, 3, and six month intervals using the Pain resource centers TMJ scale.

  24 weeks

Secondary Outcomes (1)

• Improvement in function

  24 weeks

Study Arms (2)

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

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

Biological: Group B (platelet rich plasma injection group)

Interventions

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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will need to have a history of chronic pain (at least 3 months) refractory to conservative therapy with non-steroidal anti-inflammatory medications, muscle relaxants, diet modifications and splint therapy
• Patients will also need to have imaging findings (radiography or magnetic resonance imaging) that show mild to severe degenerative changes of the temporomandibular joint

You may not qualify if:

• Patients with systemic disorders such as rheumatic diseases, hematologic diseases, active infections, immunosuppression
• Patients receiving therapy with anticoagulants

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Husam G Elias, MD, DMD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Julian J Wilson, DDS

  Kaiser Permanente

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 12, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2013
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

US (1)