Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia

NCT01771952 | Completed Results

• 1 other identifier: 14386
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how safe a knee injection called Synvisc-One® is in patients with a condition called chondromalacia patella and how well in works in treating the condition. Chondromalacia patella is a common cause of kneecap pain or front knee pain. Often called "Runner's Knee," this condition often affects young, otherwise healthy individuals. Chondromalacia is due to irritation of the undersurface of the kneecap. The undersurface of the kneecap, or patella, is covered with a layer of smooth cartilage. This cartilage normally glides effortlessly across the knee during bending of the joint. In some individuals, the cartilage on the undersurface of the knee cap becomes irritated and soft, resulting in pain. Potential treatments for this condition include rest, injections (numbing or anti-inflammatory medications to reduce swelling and pain), and/or guided strengthening exercises which may help reduce pain. Other Treatments are being evaluated. This study is about Synvisc-One® an experimental device that has been approved by the Food and Drug Administration (FDA) for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond to treatments that do not involve drugs or surgery and simple pain medication such as acetaminophen. Synvisc-One® is a gel-like substance that, when injected into a joint, acts to lubricate and cushion the joint. Synvisc-One® is made from hyaluronan, which is a molecule that is found normally in joint fluid. Synvisc-One® has not been proven to be safe or helpful in patients with chondromalacia patella (cartilage irritation or softening of the undersurface of the 'knee cap'). So far, this drug/device has been given to over 10,000 people who have knee pain (due to osteoarthritis) and has been proven safe and effective in patients with moderate to severe pain due to knee joint osteoarthritis.

Conditions

Chondromalacia Patella; Patellofemoral Pain Syndrome

Keywords

Patellofemoral Chondromalacia; Anterior Knee Pain; Patellofemoral Pain Syndrome; Synvisc-One; Hyaluronic Acid

Outcome Measures

Primary Outcomes (1)

• Knee Pain During a Single Leg Squat

  Participants will be asked to rate their worst knee pain on a visual analog scale during a deep single leg squat. The scale ranges from 0-10 where higher numbers indicate more pain. A score of 0 indicates no pain and a score of 10 indicates worst possible pain.

  Baseline, 1 month, 3 month and 6 month

Secondary Outcomes (2)

• KOOS: Patient Reported Knee Function

  Baseline, 1 month, 3 month and 6 month

• Quadriceps Muscle Function

  Baseline, 1 month, 3 month and 6 month

Study Arms (2)

Synvisc-One™

EXPERIMENTAL

Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events.

Device: Synvisc-One™

Sham Treatment

SHAM COMPARATOR

Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection.

Other: Sham Treatment

Interventions

Synvisc-One™ DEVICE

A single 6cc injection of Synvisc-One™ will be utilized in this study.

Also known as: Hyaluronan, Hyaluronic Acid

Synvisc-One™

Sham Treatment OTHER

A single needle stick without arthrocentesis or injection.

Sham Treatment

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age at time of randomization: 18-45 years
• Clinical diagnosis of anterior knee pain
• X-ray showing no fracture or osteoarthritis
• \>4 out of 10 on a visual analog scale and/or Knee \& Osteoarthritis Outcome Score (KOOS) \<7
• Persistent anterior knee pain lasting at least 3 months prior to screening
• Failed previous physical therapy intervention
• Pain/crepitus with patellar grind

You may not qualify if:

• Presence of knee/ patellofemoral joint effusion
• Patellar tendonitis
• Patellofemoral joint space narrowing as noted on Merchant/sunrise x-ray
• Diagnosis of tibiofemoral osteoarthritis
• Cruciate/ collateral knee ligament instability
• Patellofemoral joint instability
• Significant patellar or tibiofemoral mal-alignment
• Suspected meniscus injury
• Any clinical indication for arthroscopic surgery
• Significant patellar mal-tracking as noted on merchant view x-ray
• Currently enrolled in another experimental clinical trial
• Patellofemoral joint injection within the past 3 months
• Known or suspected psychological disorder
• Known allergy to avian products
• Oral steroid medications

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Hart JM, Kuenze C, Norte G, Bodkin S, Patrie J, Denny C, Hart J, Diduch DR. Prospective, Randomized, Double-Blind Evaluation of the Efficacy of a Single-Dose Hyaluronic Acid for the Treatment of Patellofemoral Chondromalacia. Orthop J Sports Med. 2019 Jun 24;7(6):2325967119854192. doi: 10.1177/2325967119854192. eCollection 2019 Jun.

  PMID: 31263727 DERIVED

MeSH Terms

Conditions

Chondromalacia Patellae; Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Joint Diseases

Results Point of Contact

• Title: Joe Hart
• Organization: University of Virginia, Kinesiology

jmh3zf@virginia.edu

4349246187

Study Officials

• Joseph Hart, PhD, ATC

  University of Virginia

  PRINCIPAL INVESTIGATOR

• David Diduch, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: January 18, 2013
• Study Start: March 1, 2010
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-09

Locations

US (1)