Complete Tear, Knee, Anterior Cruciate LigamentPhase 4HA-ACLNCT02630407
Early Viscosupplementation After ACL Reconstruction: a Randomized Controlled Trial
A Phase 4 study testing viscosupplementation in people with Complete Tear, Knee, Anterior Cruciate Ligament, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The possibility of using an intra-articular agent such as hyaluronic acid (HA) to reduce the post-operative inflammatory stress on the knee joint, limiting the use of other pain-killers and promoting a faster recovery after ACL reconstruction, seems attractive. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Complete Tear, Knee, Anterior Cruciate Ligament
- What is being tested?
- viscosupplementation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to Mar 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 and symptomatic ACL tear requiring primary surgical reconstruction;
- age between 18 and 50 years;
Who cannot join
- concurrent articular lesion requiring surgical treatment (just isolated partial meniscectomy was permitted)
- axial mal-alignment in the index limb
- unhealthy contra-lateral knee (i.e. functional limitation or pain)
- concurrent rheumatic or metabolic disease
- alterations in the other joints of the index limb (e.g.: hip or ankle disease)
- previous ACL reconstruction in the index knee
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 Post-op. Viscosupplementation After Primary Anterior Cruciate Ligament (ACL) Reconstruction: a Randomized, Placebo Controlled Trial
The possibility of using an intra-articular agent such as hyaluronic acid (HA) to reduce the post-operative inflammatory stress on the knee joint, limiting the use of other pain-killers and promoting a faster recovery after ACL reconstruction, seems attractive.
The aim of the present double blind, placebo controlled study is to evaluate the effects, both in terms of pain control and functional recovery, provided by a single HA injection performed in the early postoperative phase after ACL reconstruction.
Read more
The day after the ACL reconstruction (which is performed with the same technique for all the patients enrolled), the patients were randomized to receive a single injection of HA or 3 ml of saline solution. The randomization list was kept in a dedicated office and the injecting physician contacted it to know the treatment allocation just before the injection, that was performed by a lateral parapatellar approach, after removing the drainages and after attempting aspiration to evacuate any eventual residual blood from the joint. In order to maintain the patient blind to the treatment, a surgical drape was placed to prevent him to see the injective procedure.
All patients will be evaluated at 15, 30, 60, 180 and 360 days after surgery by using the following tools: SF-36, IKDC subjective, VAS for pain, EQ-VAS for general Health Status and Tegner score. Also the trans-patellar circumference and active and passive ROM of both knees were registered at each follow-up evaluation.
Read the detailed description
Viscosupplementation is an injective approach used in the orthopaedic practice to manage chondropathy and osteoarthritis (OA) in different joints. In the last decades, several products have been developed by biomedical industries, with different biochemical and physical properties, with the aim of providing the best and long-lasting beneficial effects in OA patients. The rational supporting the use of viscosupplementation is due both to its biomechanical and biological actions. First of all, hyaluronic acid (HA) exerts a lubricant effect improving the rheological properties of synovial fluid thus reducing the mechanical stresses within the joint that are responsible for the activation of nociceptors and further cartilage surface wear. Furthermore, HA binds to cellular receptors and further stimulates endogenous production of hyaluronan, other extracellular matrix components, and it also counteracts inflammatory molecules and proteases that are overexpressed in a diseased joint . In light of these features, HA could be considered an "intra-articular drug" which can act both as a pain killer and joint regulator agent. These properties could be theoretically exploited also for different clinical applications than a chronic disease like OA. In particular, viscosupplementation might play a beneficial role in restoring the overall joint homeostasis and might contribute to reduce pro-inflammatory stimuli after knee surgical procedures, thus reducing pain and accelerating functional recovery. Anterior cruciate ligament (ACL) reconstruction is one of the most common procedures in the field of sports medicine . It is common for patients to experience persistent knee swelling after the surgical procedure, and this increases pain and delays the start of the rehabilitation program, thus prolonging the times of full functional recovery. The possibility of using an intra-articular agent such as HA to reduce the post-operative inflammatory stress on the knee, limiting the use of other pain-killers and promoting a faster recovery after ACL reconstruction, seems therefore attractive.
The aim of the present double blind, placebo controlled randomized study is to evaluate the effects, both in terms of pain control and functional recovery, provided by a single HA injection performed in the early postoperative phase after ACL reconstruction.
The day after the ACL reconstruction (which is performed with the same technique for all the subjects enrolled), the patients were randomized to receive a single injection of HA or 3 ml of saline solution. The randomization list was kept in a dedicated office and the injecting physician contacted this office to know the treatment allocation just before the injection, that was performed by a lateral parapatellar approach, after removing the drainages and after attempting aspiration to evacuate any eventual residual blood from the joint. In order to maintain the patient blind to the treatment, a surgical drape was placed to prevent him to see the injective procedure.
All patients will be evaluated at 15, 30, 60, 180 and 360 days after surgery by using the following tools: SF-36, IKDC subjective, VAS for pain, EQ-VAS for general Health Status and Tegner score. Also the trans-patellar circumference and active and passive ROM of both knees were registered at each follow-up evaluation.
- Being tested
- viscosupplementation, Placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
viscosupplementationBiological
A single 3 ml hyaluronic acid (HA) injection (viscosupplementation) performed the day after ACL reconstruction, after drainage removal
Placebo groupOther
A single 3 ml saline injection performed the day after ACL reconstruction, after drainage removal
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid group | Experimental | Single injection of 3 ml HA (product name: Hymovis, Fidia Spa, Padova, Italy) the day after ACL reconstruction (after drainage removal) Receives: Biological: viscosupplementation |
| Placebo group | Placebo comparator | Single injection of 3 ml saline solution the day after ACL reconstruction (after drainage removal) Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IKDC (International Knee Documentation Committee) Subjective score
Measured: basal, 6 and 12 months post-op
Secondary outcomes (10)
Change in Tegner Score
Measured: basal, 6 and 12 months
Transpatellar circumference trend
Measured: basal, 15, 30, 60, 180 days post op
Trend in Active and Passive Range of Motion (ROM) of the knee
Measured: basal, 15, 30, 60, 180 days post op
Change in VAS (Visual Analogue Scale) for general health status
Measured: basal, 15, 30, 60, 180 days post op
Change in VAS for pain
Measured: basal, 15, 30, 60, 180 days post op
Change in SF-36 (Short Form Health Survey) Score
Measured: basal, 6 and 12 months post-op
Adverse events report
Measured: 15 days
Adverse events report
Measured: 30 days
Adverse events report
Measured: 60 days
Adverse events report
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startDec 2012
- Primary completionMar 2016
- Study completionMar 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 Complete Tear, Knee, Anterior Cruciate LigamentStudies 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
- Model description
- injection of saline VS injection of Hyaluronic acid
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 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 & Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630407
- Sponsor's protocol ID
- Rizzoli HA-ACL
- Acronym
- HA-ACL
- Status last verified
- Sep 2017
- First submitted
- 30 Nov 2015
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monticone M, Frizziero A, Rovere G, Vittadini F, Uliano D, LA Bruna S, Gatto R, Nava C, Leggero V, Masiero S. Hyaluronic acid intra-articular injection and exercise therapy: effects on pain and disability in subjects affected by lower limb joints osteoarthritis. A systematic review by the Italian Society of Physical and Rehabilitation Medicine (SIMFER). Eur J Phys Rehabil Med. 2016 Jun;52(3):389-99. Epub 2015 Sep 10.
PubMed 26365146Henrotin Y, Raman R, Richette P, Bard H, Jerosch J, Conrozier T, Chevalier X, Migliore A. Consensus statement on viscosupplementation with hyaluronic acid for the management of osteoarthritis. Semin Arthritis Rheum. 2015 Oct;45(2):140-9. doi: 10.1016/j.semarthrit.2015.04.011. Epub 2015 Apr 30.
PubMed 26094903Campbell KA, Erickson BJ, Saltzman BM, Mascarenhas R, Bach BR Jr, Cole BJ, Verma NN. Is Local Viscosupplementation Injection Clinically Superior to Other Therapies in the Treatment of Osteoarthritis of the Knee: A Systematic Review of Overlapping Meta-analyses. Arthroscopy. 2015 Oct;31(10):2036-45.e14. doi: 10.1016/j.arthro.2015.03.030. Epub 2015 May 19.
PubMed 25998016Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.
PubMed 25952818Macdonald SA, Heard SM, Hiemstra LA, Buchko GM, Kerslake S, Sasyniuk TM. A comparison of pain scores and medication use in patients undergoing single-bundle or double-bundle anterior cruciate ligament reconstruction. Can J Surg. 2014 Jun;57(3):E98-104. doi: 10.1503/cjs.018612.
PubMed 24869623Braithwaite GJ, Daley MJ, Toledo-Velasquez D. Rheological and molecular weight comparisons of approved hyaluronic acid products - preliminary standards for establishing class III medical device equivalence. J Biomater Sci Polym Ed. 2016;27(3):235-46. doi: 10.1080/09205063.2015.1119035. Epub 2015 Dec 31.
PubMed 26569146Chau JY, Chan WL, Woo SB, Cheng SC, Wong TM, Wong TK, Yen CH, Wong K, Wong WC. Hyaluronic acid instillation following arthroscopic anterior cruciate ligament reconstruction: a double-blinded, randomised controlled study. J Orthop Surg (Hong Kong). 2012 Aug;20(2):162-5. doi: 10.1177/230949901202000205.
PubMed 22933671Huang MH, Yang RC, Chou PH. Preliminary effects of hyaluronic acid on early rehabilitation of patients with isolated anterior cruciate ligament reconstruction. Clin J Sport Med. 2007 Jul;17(4):242-50. doi: 10.1097/JSM.0b013e31812570fa.
PubMed 17620776Di Martino A, Tentoni F, Di Matteo B, Cavicchioli A, Lo Presti M, Filardo G, Zaffagnini S, Marcacci M, Kon E. Early Viscosupplementation After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Am J Sports Med. 2016 Oct;44(10):2572-2578. doi: 10.1177/0363546516654909. Epub 2016 Jul 27.
PubMed 27466224
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 Post-op. Viscosupplementation After Primary Anterior Cruciate Ligament (ACL) Reconstruction: a Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02630407
- Acronym / sponsor ID
- HA-ACL / Rizzoli HA-ACL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 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 possibility of using an intra-articular agent such as hyaluronic acid (HA) to reduce the post-operative inflammatory stress on the knee joint, limiting the use of other pain-killers and promoting a faster recovery after ACL reconstruction, seems attractive.
The aim of the present double blind, placebo controlled study is to evaluate the effects, both in terms of pain control and functional recovery, provided by a single HA injection performed in the early postoperative phase after ACL reconstruction.
The day after the ACL reconstruction (which is performed with the same technique for all the patients enrolled), the patients were randomized to receive a single injection of HA or 3 ml of saline solution. The randomization list was kept in a dedicated office and the injecting physician contacted it to know the treatment allocation just before the injection, that was performed by a lateral parapatellar approach, after removing the drainages and after attempting aspiration to evacuate any eventual residual blood from the joint. In order to maintain the patient blind to the treatment, a surgical drape was placed to prevent him to see the injective procedure.
All patients will be evaluated at 15, 30, 60, 180 and 360 days after surgery by using the following tools: SF-36, IKDC subjective, VAS for pain, EQ-VAS for general Health Status and Tegner score. Also the trans-patellar circumference and active and passive ROM of both knees were registered at each follow-up evaluation.
Detailed description
Viscosupplementation is an injective approach used in the orthopaedic practice to manage chondropathy and osteoarthritis (OA) in different joints. In the last decades, several products have been developed by biomedical industries, with different biochemical and physical properties, with the aim of providing the best and long-lasting beneficial effects in OA patients. The rational supporting the use of viscosupplementation is due both to its biomechanical and biological actions. First of all, hyaluronic acid (HA) exerts a lubricant effect improving the rheological properties of synovial fluid thus reducing the mechanical stresses within the joint that are responsible for the activation of nociceptors and further cartilage surface wear. Furthermore, HA binds to cellular receptors and further stimulates endogenous production of hyaluronan, other extracellular matrix components, and it also counteracts inflammatory molecules and proteases that are overexpressed in a diseased joint . In light of these features, HA could be considered an "intra-articular drug" which can act both as a pain killer and joint regulator agent. These properties could be theoretically exploited also for different clinical applications than a chronic disease like OA. In particular, viscosupplementation might play a beneficial role in restoring the overall joint homeostasis and might contribute to reduce pro-inflammatory stimuli after knee surgical procedures, thus reducing pain and accelerating functional recovery. Anterior cruciate ligament (ACL) reconstruction is one of the most common procedures in the field of sports medicine . It is common for patients to experience persistent knee swelling after the surgical procedure, and this increases pain and delays the start of the rehabilitation program, thus prolonging the times of full functional recovery. The possibility of using an intra-articular agent such as HA to reduce the post-operative inflammatory stress on the knee, limiting the use of other pain-killers and promoting a faster recovery after ACL reconstruction, seems therefore attractive.
The aim of the present double blind, placebo controlled randomized study is to evaluate the effects, both in terms of pain control and functional recovery, provided by a single HA injection performed in the early postoperative phase after ACL reconstruction.
The day after the ACL reconstruction (which is performed with the same technique for all the subjects enrolled), the patients were randomized to receive a single injection of HA or 3 ml of saline solution. The randomization list was kept in a dedicated office and the injecting physician contacted this office to know the treatment allocation just before the injection, that was performed by a lateral parapatellar approach, after removing the drainages and after attempting aspiration to evacuate any eventual residual blood from the joint. In order to maintain the patient blind to the treatment, a surgical drape was placed to prevent him to see the injective procedure.
All patients will be evaluated at 15, 30, 60, 180 and 360 days after surgery by using the following tools: SF-36, IKDC subjective, VAS for pain, EQ-VAS for general Health Status and Tegner score. Also the trans-patellar circumference and active and passive ROM of both knees were registered at each follow-up evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- injection of saline VS injection of Hyaluronic acid
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid group | Experimental | Biological: viscosupplementationSingle injection of 3 ml HA (product name: Hymovis, Fidia Spa, Padova, Italy) the day after ACL reconstruction (after drainage removal) |
| Placebo group | Placebo comparator | Other: Placebo groupSingle injection of 3 ml saline solution the day after ACL reconstruction (after drainage removal) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- chronic and symptomatic ACL tear requiring primary surgical reconstruction;
- age between 18 and 50 years;
Key exclusion criteria (6 listed)
- concurrent articular lesion requiring surgical treatment (just isolated partial meniscectomy was permitted)
- axial mal-alignment in the index limb
- unhealthy contra-lateral knee (i.e. functional limitation or pain)
- concurrent rheumatic or metabolic disease
- alterations in the other joints of the index limb (e.g.: hip or ankle disease)
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 |
|---|---|---|
| viscosupplementationA single 3 ml hyaluronic acid (HA) injection (viscosupplementation) performed the day after ACL reconstruction, after drainage removal | Biological | Hyaluronic acid group |
| Placebo groupA single 3 ml saline injection performed the day after ACL reconstruction, after drainage removal | Other | Placebo group |
Primary outcome
Change in IKDC (International Knee Documentation Committee) Subjective score
Time frame: basal, 6 and 12 months post-op
10 secondary outcomes
Change in Tegner Score
Time frame: basal, 6 and 12 months
Transpatellar circumference trend
Time frame: basal, 15, 30, 60, 180 days post op
Trend in Active and Passive Range of Motion (ROM) of the knee
Time frame: basal, 15, 30, 60, 180 days post op
Change in VAS (Visual Analogue Scale) for general health status
Time frame: basal, 15, 30, 60, 180 days post op
Change in VAS for pain
Time frame: basal, 15, 30, 60, 180 days post op
Change in SF-36 (Short Form Health Survey) Score
Time frame: basal, 6 and 12 months post-op
Adverse events report
Time frame: 15 days
Adverse events report
Time frame: 30 days
Adverse events report
Time frame: 60 days
Adverse events report
Time frame: 180 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 26365146Monticone M, Frizziero A, Rovere G, Vittadini F, Uliano D, LA Bruna S, Gatto R, Nava C, Leggero V, Masiero S. Hyaluronic acid intra-articular injection and exercise therapy: effects on pain and disability in subjects affected by lower limb joints osteoarthritis. A systematic review by the Italian Society of Physical and Rehabilitation Medicine (SIMFER). Eur J Phys Rehabil Med. 2016 Jun;52(3):389-99. Epub 2015 Sep 10.
- Background: PubMed 26094903Henrotin Y, Raman R, Richette P, Bard H, Jerosch J, Conrozier T, Chevalier X, Migliore A. Consensus statement on viscosupplementation with hyaluronic acid for the management of osteoarthritis. Semin Arthritis Rheum. 2015 Oct;45(2):140-9. doi: 10.1016/j.semarthrit.2015.04.011. Epub 2015 Apr 30.
- Background: PubMed 25998016Campbell KA, Erickson BJ, Saltzman BM, Mascarenhas R, Bach BR Jr, Cole BJ, Verma NN. Is Local Viscosupplementation Injection Clinically Superior to Other Therapies in the Treatment of Osteoarthritis of the Knee: A Systematic Review of Overlapping Meta-analyses. Arthroscopy. 2015 Oct;31(10):2036-45.e14. doi: 10.1016/j.arthro.2015.03.030. Epub 2015 May 19.
- Background: PubMed 25952818Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.
- Background: PubMed 24869623Macdonald SA, Heard SM, Hiemstra LA, Buchko GM, Kerslake S, Sasyniuk TM. A comparison of pain scores and medication use in patients undergoing single-bundle or double-bundle anterior cruciate ligament reconstruction. Can J Surg. 2014 Jun;57(3):E98-104. doi: 10.1503/cjs.018612.
- Background: PubMed 26569146Braithwaite GJ, Daley MJ, Toledo-Velasquez D. Rheological and molecular weight comparisons of approved hyaluronic acid products - preliminary standards for establishing class III medical device equivalence. J Biomater Sci Polym Ed. 2016;27(3):235-46. doi: 10.1080/09205063.2015.1119035. Epub 2015 Dec 31.
- Background: PubMed 22933671Chau JY, Chan WL, Woo SB, Cheng SC, Wong TM, Wong TK, Yen CH, Wong K, Wong WC. Hyaluronic acid instillation following arthroscopic anterior cruciate ligament reconstruction: a double-blinded, randomised controlled study. J Orthop Surg (Hong Kong). 2012 Aug;20(2):162-5. doi: 10.1177/230949901202000205.
- Background: PubMed 17620776Huang MH, Yang RC, Chou PH. Preliminary effects of hyaluronic acid on early rehabilitation of patients with isolated anterior cruciate ligament reconstruction. Clin J Sport Med. 2007 Jul;17(4):242-50. doi: 10.1097/JSM.0b013e31812570fa.
- Derived from this study: PubMed 27466224Di Martino A, Tentoni F, Di Matteo B, Cavicchioli A, Lo Presti M, Filardo G, Zaffagnini S, Marcacci M, Kon E. Early Viscosupplementation After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Am J Sports Med. 2016 Oct;44(10):2572-2578. doi: 10.1177/0363546516654909. Epub 2016 Jul 27.
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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 & Nano-biotechnology Lab, Rizzoli Orthopaedic 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 viscosupplementation in people with Complete Tear, Knee, Anterior Cruciate Ligament, 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 6 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. 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.
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) Subjective score (time frame: basal, 6 and 12 months post-op). 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 NCT02630407, 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.