Chondromalacia PatellaNCT01771952
Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia
A study testing Synvisc-One™ in people with Chondromalacia Patella and Patellofemoral Pain Syndrome, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Chondromalacia Patella, Patellofemoral Pain Syndrome
- What is being tested?
- Synvisc-One™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Prospective, Randomized, Double Blind Evaluation of the Efficacy of a Single Dose of Synvisc-One® (6.0 cc) for the Treatment of Patellofemoral Chondromalacia
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.
Read more
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.
Read the 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
- Being tested
- Synvisc-One™, Sham Treatment
- Keywords
- Patellofemoral Chondromalacia, Anterior Knee Pain, Patellofemoral Pain Syndrome, Synvisc-One, Hyaluronic Acid
- Medical subject headings
- Chondromalacia Patellae, Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synvisc-One™Device
Also called Hyaluronan, Hyaluronic Acid
A single 6cc injection of Synvisc-One™ will be utilized in this study.
Sham TreatmentOther
A single needle stick without arthrocentesis or injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 month and 6 month
Secondary outcomes (2)
KOOS: Patient Reported Knee Function
Patients will be asked to complete several validated questionnaires to assess their knee symptoms and daily function. The Knee Osteoarthritis Outcome Score (KOOS) was used as a cumulative score that included all sub-scales. The resultant score ranged from 0-100 where higher scores indicated better function.
Measured: Baseline, 1 month, 3 month and 6 month
Quadriceps Muscle Function
Participants will contract their thigh muscle as hard as possible in order to measure their maximum strength. The outcome measure is maximum strength expressed in Newton-meters/kilogram. This outcome ranges from 0 indicating no strength to infinity where higher scores indicate stronger muscles.
Measured: Baseline, 1 month, 3 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startMar 2010
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chondromalacia PatellaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Hart, University of Virginia
- Investigators
- Joseph Hart, PhD, ATC, Principal investigator, University of VirginiaDavid Diduch, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771952
- Sponsor's protocol ID
- 14386
- Status last verified
- Sep 2020
- First submitted
- 15 May 2012
- Last updated
- 4 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31263727
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double Blind Evaluation of the Efficacy of a Single Dose of Synvisc-One® (6.0 cc) for the Treatment of Patellofemoral Chondromalacia
- ClinicalTrials.gov ID
- NCT01771952
- Acronym / sponsor ID
- 14386
- Keywords
- Patellofemoral Chondromalacia, Anterior Knee Pain, Patellofemoral Pain Syndrome, Synvisc-One, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Posted 4 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synvisc-One™ | Experimental | Device: 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. |
| Sham Treatment | Sham comparator | Other: Sham TreatmentPatients 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. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (26 listed)
- 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
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 |
|---|---|---|
| Synvisc-One™Also: Hyaluronan, Hyaluronic AcidA single 6cc injection of Synvisc-One™ will be utilized in this study. | Device | Synvisc-One™ |
| Sham TreatmentA single needle stick without arthrocentesis or injection. | Other | Sham Treatment |
Primary outcome
Knee Pain During a Single Leg Squat
Time frame: Baseline, 1 month, 3 month and 6 month
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.
2 secondary outcomes
KOOS: Patient Reported Knee Function
Time frame: Baseline, 1 month, 3 month and 6 month
Quadriceps Muscle Function
Time frame: Baseline, 1 month, 3 month and 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31263727Hart 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.
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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.
Joseph Hart, PhD, ATC principal investigator
University of Virginia
David Diduch, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synvisc-One™ in people with Chondromalacia Patella and Patellofemoral Pain Syndrome, run by University of Virginia 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 7 inclusion and 26 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: finished, as of the sponsor's last update on 4 Sep 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Knee Pain During a Single Leg Squat (time frame: Baseline, 1 month, 3 month and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01771952, which also lists 1 linked publication.
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 4 Sep 2020.