Ignite Creation Date:
2024-05-06 @ 1:19 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01771952
Status:
COMPLETED
Last Update Posted:
2020-09-04
First Post:
2012-05-15
Brief Title:
Randomized Evaluation of the Efficacy of Synvisc-One for the Treatment of Patellofemoral Chondromalacia
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Prospective Randomized Double Blind Evaluation of the Efficacy of a Single Dose of Synvisc-One 60 cc for the Treatment of Patellofemoral Chondromalacia
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Runners 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 andor 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 drugdevice has been given to over 10000 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
Chondromalacia patella is a common cause of kneecap pain or front knee pain Often called Runners 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 andor 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 drugdevice has been given to over 10000 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 Nkg
Randomization
Each subject will be randomly assigned in a 11 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 307 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 917 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 18214 days following injection The following outcomes will be recorded during this visit
Subjective outcomes
Clinical Evaluation
Quadriceps strength testing
Concomitant medications
Adverse Events
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 Nkg
Randomization
Each subject will be randomly assigned in a 11 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 307 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 917 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 18214 days following injection The following outcomes will be recorded during this visit
Subjective outcomes
Clinical Evaluation
Quadriceps strength testing
Concomitant medications
Adverse Events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None