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

NCT ID: NCT01771952

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2016-10-31

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.

Detailed Description

Study Procedures:

Screening visit:

After written informed consent is obtained, initial screening will consist of a thorough medical history and physical examination and standing, bilateral PA, lateral and merchant view x-ray evaluation. Special attention will be given to inclusion and exclusion criteria as listed above. Only patients who meet all inclusion and exclusion criteria will be allowed to continue to Baseline outcomes data collection and randomization. The following subjective outcomes, clinical examination and quadriceps strength data will be collected at each session.

Subjective Outcomes

• Knee Injury Outcome and Osteoarthritis Score (KOOS)
• Anterior knee pain rating during single-leg squat (10cm visual analog scale-VAS)

Quadriceps strength testing

• Maximal, normalized isometric knee extension force (N/kg)

Randomization:

Each subject will be randomly assigned in a 1:1 ratio to receive one of the treatments (group) described above. Randomization will be done a priori via a random number generator. Group assignments will be sealed in an envelope each containing a number from 001-100. Randomization envelope #001 will be used for the first subject, #002 for the second and so on.

Blinding:

Both examiner and patient will be blinded to treatment/ group assignment. During the injection procedure, we will block patients' view of the injection with the use of a physical screen (pillowcase, blanket, sheet, etc) in order to assure the patient is blinded to treatment. Patients will be "un-blinded" after the final study endpoints have been collected or if needed due to early withdraw or other medical emergency. To maintain blinding and avoid measurement bias, the injecting physician will be different from the investigators performing outcomes assessments.

Medication/ Treatment Restrictions and Monitoring:

• Patients will be instructed to refrain from any other intra-articular treatment or therapy while enrolled in this study
• Patients will be interviewed regarding medication usage (dosage and frequency) at each visit.
• Patients will be instructed to refrain from using any medicine for pain with the exception of OTC Tylenol.

Standardized Exercise prescription:

Patients will be prescribed a standardized home-based quadriceps strengthening program. Patients will be educated on duration and frequency for exercises and will be provided an exercise log that will provide exercise descriptions and reminders as well as a method for exercise compliance. Subjects will return exercise books at each visit for compliance recording.

Follow-up visits

• 1 month following injection: Patients will return at 4 weeks (approx 30±7 days) following injection. The following outcomes will be recorded during this visit:

• Subjective outcomes
• Clinical Evaluation
• Quadriceps strength testing
• Concomitant medications
• Adverse Events
• 3 months following injection: Patients will return at 12 weeks (approx 91±7 days) following injection. The following outcomes will be recorded during this visit:

• Subjective outcomes
• Clinical Evaluation
• Quadriceps strength testing
• Concomitant medications
• Adverse Events
• 6 months following injection: Patients will return at 26 weeks (approx 182±14 days) following injection. The following outcomes will be recorded during this visit:

• Subjective outcomes
• Clinical Evaluation
• Quadriceps strength testing
• Concomitant medications
• Adverse Events

Conditions

Chondromalacia Patella; Patellofemoral Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Synvisc-One™

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.

Group Type: EXPERIMENTAL

Synvisc-One™

Intervention Type: DEVICE

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

Sham Treatment

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.

Group Type: SHAM_COMPARATOR

Sham Treatment

Intervention Type: OTHER

A single needle stick without arthrocentesis or injection.

Interventions

Synvisc-One™

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

Intervention Type: DEVICE

Sham Treatment

A single needle stick without arthrocentesis or injection.

Intervention Type: OTHER

Other Intervention Names

Hyaluronan; Hyaluronic Acid

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Intra-articular (knee joint) steroids in the past 6 months
• Any prior use of viscosupplements
• Pregnant or breast feeding
• Body mass index > 40
• Prior surgery in the knees (excludes debridement only procedures)
• Clinical evidence of hip disease
• Any form of inflammatory arthritis ( e.g. RA, gout, pseudogout, lupus, etc)
• Significant co-morbid conditions as determined by the investigator
• Willing to refrain from chiropractic treatment or acupuncture during the study
• Any other intra-articular knee joint injection during the study
• Kellgren Lawrence grade osteoarthritis of II, III or IV

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Joseph Hart

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Hart, PhD, ATC

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

David Diduch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31263727 (View on PubMed)

Other Identifiers

14386

Identifier Type: -

Identifier Source: org_study_id