Meniscus LesionPhase 4HA-MENNCT02629380
Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial
A Phase 4 study testing hyaluronic acid and meniscectomy alone in people with Meniscus Lesion, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The rational of intra-articular viscosupplementation is based on both the biological and mechanical properties of HA, which exerts positive effects on the modulation of the entire joint environment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Meniscus Lesion
- What is being tested?
- hyaluronic acid and meniscectomy alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic symptomatic meniscal tears requiring partial resection;
- healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);
Who cannot join
- previous surgery on the index knee;
- other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
- history of knee infectious arthritis;
- concurrent rheumatic, metabolic or severe systemic disease;
- Body Mass Index (BMI) > 30;
- known hypersensibility or allergy to/towards HA ;
- alcohol or other substances abuse/excess.
Trial locations and contacts
1 site in 1 country.
Italy1 site
II Orthopaedic Clinic, Rizzoli Orthopaedic Institute
Bologna, Emilia-Romagna, 40136
About this study
Official title: Early Viscosupplementation After Partial Meniscectomy: a Double Blind, Placebo Controlled Randomized Trial
The rational of intra-articular viscosupplementation is based on both the biological and mechanical properties of HA, which exerts positive effects on the modulation of the entire joint environment.
The aim of the present double blind controlled study was to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of HA performed at the end of arthroscopic partial meniscectomy.
Read more
Patients included in this trial were randomized in two treatment groups: the first one received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy) at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery alone.
All patients were evaluated basally, at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time.
- Conditions
- Meniscus Lesion
- Being tested
- hyaluronic acid, meniscectomy alone
- Keywords
- meniscectomy, hyaluronic acid, intra-op injection, randomized controlled trial, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acidBiological
A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy
meniscectomy aloneProcedure or surgery
The patients randomized in this group will receive arthroscopic meniscectomy alone
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid group | Experimental | Single injection of 3 ml HA (Hymovis, Fidia Farmaceutici SpA, Padova, Italy) at the end of the arthroscopic meniscectomy Receives: Biological: hyaluronic acid |
| meniscectomy alone | Other | Arthroscopic meniscectomy alone Receives: Procedure: meniscectomy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IKDC (International Knee Documentation Committee) score
Measured: basal, 15,30,60,180 days
Secondary outcomes (9)
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)
Measured: basal, 15,30,60,180 days
Change in Tegner Score
Measured: basal, 15,30,60,180 days
Change in VAS (Visual Analogue Scale) for pain
Measured: basal, 15,30,60,180 days
Change in EQ-VAS for general health
Measured: basal, 15,30,60,180 days
Change in transpatellar circumference over time
Measured: basal, 15,30,60,180 days
Change in active and passive ROM
Measured: basal, 15,30,60,180 days
Adverse events report
Measured: 15 days
Adverse events report
Measured: 30 days
Adverse events report
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startDec 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Meniscus LesionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federica Balboni, Istituto Ortopedico Rizzoli
- Investigators
- Elizaveta Kon, MD, Principal investigator, II Clinic and Nano-biotechnology Lab, Rizzoli Orthopedic Institute, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629380
- Sponsor's protocol ID
- Rizzoli HA-MEN
- Acronym
- HA-MEN
- Status last verified
- Sep 2017
- First submitted
- 10 Dec 2015
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Edouard P, Rannou F, Coudeyre E. Animal evidence for hyaluronic acid efficacy in knee trauma injuries. Review of animal-model studies. Phys Ther Sport. 2013 May;14(2):116-23. doi: 10.1016/j.ptsp.2013.02.001. Epub 2013 Mar 16.
PubMed 23506791Freymann U, Endres M, Goldmann U, Sittinger M, Kaps C. Toward scaffold-based meniscus repair: effect of human serum, hyaluronic acid and TGF-ss3 on cell recruitment and re-differentiation. Osteoarthritis Cartilage. 2013 May;21(5):773-81. doi: 10.1016/j.joca.2013.02.655. Epub 2013 Mar 5.
PubMed 23473977Thein R, Haviv B, Kidron A, Bronak S. Intra-articular injection of hyaluronic acid following arthroscopic partial meniscectomy of the knee. Orthopedics. 2010 Oct 11;33(10):724. doi: 10.3928/01477447-20100826-11.
PubMed 20954664Tan GK, Dinnes DL, Butler LN, Cooper-White JJ. Interactions between meniscal cells and a self assembled biomimetic surface composed of hyaluronic acid, chitosan and meniscal extracellular matrix molecules. Biomaterials. 2010 Aug;31(23):6104-18. doi: 10.1016/j.biomaterials.2010.04.018. Epub 2010 May 14.
PubMed 20471080Westrich G, Schaefer S, Walcott-Sapp S, Lyman S. Randomized prospective evaluation of adjuvant hyaluronic acid therapy administered after knee arthroscopy. Am J Orthop (Belle Mead NJ). 2009 Dec;38(12):612-6.
PubMed 20145786Waddell DD, Bert JM. The use of hyaluronan after arthroscopic surgery of the knee. Arthroscopy. 2010 Jan;26(1):105-11. doi: 10.1016/j.arthro.2009.05.009. Epub 2009 Nov 25.
PubMed 20117634Cake M, Read R, Edwards S, Smith MM, Burkhardt D, Little C, Ghosh P. Changes in gait after bilateral meniscectomy in sheep: effect of two hyaluronan preparations. J Orthop Sci. 2008 Nov;13(6):514-23. doi: 10.1007/s00776-008-1279-6. Epub 2008 Dec 17.
PubMed 19089539Mathies B. Effects of Viscoseal, a synovial fluid substitute, on recovery after arthroscopic partial meniscectomy and joint lavage. Knee Surg Sports Traumatol Arthrosc. 2006 Jan;14(1):32-9. doi: 10.1007/s00167-005-0625-x. Epub 2005 May 26.
PubMed 15918064Filardo G, Di Matteo B, Tentoni F, Cavicchioli A, Di Martino A, Lo Presti M, Iacono F, Kon E, Marcacci M. No Effects of Early Viscosupplementation After Arthroscopic Partial Meniscectomy: A Randomized Controlled Trial. Am J Sports Med. 2016 Dec;44(12):3119-3125. doi: 10.1177/0363546516660070. Epub 2016 Aug 15.
PubMed 27528611
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Viscosupplementation After Partial Meniscectomy: a Double Blind, Placebo Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT02629380
- Acronym / sponsor ID
- HA-MEN / Rizzoli HA-MEN
- Conditions
- Meniscus Lesion
- Keywords
- meniscectomy, hyaluronic acid, intra-op injection, randomized controlled trial, placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rational of intra-articular viscosupplementation is based on both the biological and mechanical properties of HA, which exerts positive effects on the modulation of the entire joint environment.
The aim of the present double blind controlled study was to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of HA performed at the end of arthroscopic partial meniscectomy.
Patients included in this trial were randomized in two treatment groups: the first one received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy) at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery alone.
All patients were evaluated basally, at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid group | Experimental | Biological: hyaluronic acidSingle injection of 3 ml HA (Hymovis, Fidia Farmaceutici SpA, Padova, Italy) at the end of the arthroscopic meniscectomy |
| meniscectomy alone | Other | Procedure: meniscectomy aloneArthroscopic meniscectomy alone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- chronic symptomatic meniscal tears requiring partial resection;
- healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);
Key exclusion criteria (7 listed)
- previous surgery on the index knee;
- other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
- history of knee infectious arthritis;
- concurrent rheumatic, metabolic or severe systemic disease;
- Body Mass Index (BMI) > 30;
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 |
|---|---|---|
| hyaluronic acidA single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy | Biological | Hyaluronic acid group |
| meniscectomy aloneThe patients randomized in this group will receive arthroscopic meniscectomy alone | Procedure or surgery | meniscectomy alone |
Primary outcome
Change in IKDC (International Knee Documentation Committee) score
Time frame: basal, 15,30,60,180 days
9 secondary outcomes
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: basal, 15,30,60,180 days
Change in Tegner Score
Time frame: basal, 15,30,60,180 days
Change in VAS (Visual Analogue Scale) for pain
Time frame: basal, 15,30,60,180 days
Change in EQ-VAS for general health
Time frame: basal, 15,30,60,180 days
Change in transpatellar circumference over time
Time frame: basal, 15,30,60,180 days
Change in active and passive ROM
Time frame: basal, 15,30,60,180 days
Adverse events report
Time frame: 15 days
Adverse events report
Time frame: 30 days
Adverse events report
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Background: PubMed 23506791Edouard P, Rannou F, Coudeyre E. Animal evidence for hyaluronic acid efficacy in knee trauma injuries. Review of animal-model studies. Phys Ther Sport. 2013 May;14(2):116-23. doi: 10.1016/j.ptsp.2013.02.001. Epub 2013 Mar 16.
- Background: PubMed 23473977Freymann U, Endres M, Goldmann U, Sittinger M, Kaps C. Toward scaffold-based meniscus repair: effect of human serum, hyaluronic acid and TGF-ss3 on cell recruitment and re-differentiation. Osteoarthritis Cartilage. 2013 May;21(5):773-81. doi: 10.1016/j.joca.2013.02.655. Epub 2013 Mar 5.
- Background: PubMed 20954664Thein R, Haviv B, Kidron A, Bronak S. Intra-articular injection of hyaluronic acid following arthroscopic partial meniscectomy of the knee. Orthopedics. 2010 Oct 11;33(10):724. doi: 10.3928/01477447-20100826-11.
- Background: PubMed 20471080Tan GK, Dinnes DL, Butler LN, Cooper-White JJ. Interactions between meniscal cells and a self assembled biomimetic surface composed of hyaluronic acid, chitosan and meniscal extracellular matrix molecules. Biomaterials. 2010 Aug;31(23):6104-18. doi: 10.1016/j.biomaterials.2010.04.018. Epub 2010 May 14.
- Background: PubMed 20145786Westrich G, Schaefer S, Walcott-Sapp S, Lyman S. Randomized prospective evaluation of adjuvant hyaluronic acid therapy administered after knee arthroscopy. Am J Orthop (Belle Mead NJ). 2009 Dec;38(12):612-6.
- Background: PubMed 20117634Waddell DD, Bert JM. The use of hyaluronan after arthroscopic surgery of the knee. Arthroscopy. 2010 Jan;26(1):105-11. doi: 10.1016/j.arthro.2009.05.009. Epub 2009 Nov 25.
- Background: PubMed 19089539Cake M, Read R, Edwards S, Smith MM, Burkhardt D, Little C, Ghosh P. Changes in gait after bilateral meniscectomy in sheep: effect of two hyaluronan preparations. J Orthop Sci. 2008 Nov;13(6):514-23. doi: 10.1007/s00776-008-1279-6. Epub 2008 Dec 17.
- Background: PubMed 15918064Mathies B. Effects of Viscoseal, a synovial fluid substitute, on recovery after arthroscopic partial meniscectomy and joint lavage. Knee Surg Sports Traumatol Arthrosc. 2006 Jan;14(1):32-9. doi: 10.1007/s00167-005-0625-x. Epub 2005 May 26.
- Derived from this study: PubMed 27528611Filardo G, Di Matteo B, Tentoni F, Cavicchioli A, Di Martino A, Lo Presti M, Iacono F, Kon E, Marcacci M. No Effects of Early Viscosupplementation After Arthroscopic Partial Meniscectomy: A Randomized Controlled Trial. Am J Sports Med. 2016 Dec;44(12):3119-3125. doi: 10.1177/0363546516660070. Epub 2016 Aug 15.
- Individual participant dataSharing planned: No
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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.
Elizaveta Kon, MD principal investigator
II Clinic and Nano-biotechnology Lab, Rizzoli Orthopedic Institute, Bologna, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hyaluronic acid and meniscectomy alone in people with Meniscus Lesion, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 2 inclusion and 7 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 13 Sep 2017. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in IKDC (International Knee Documentation Committee) score (time frame: basal, 15,30,60,180 days). 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 NCT02629380, which also lists 9 linked publications.
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 13 Sep 2017.