The Focus of the Study is the Quality and Amount of Regenerated Articular Cartilage.CulturedNCT01961973
A Study to Compare Two Techniques for Articular Cartilage Repair: Cultured Chondrocytes Vs. Cultured BMAC
A study testing Cultured Chondrocytes and Cultured BMAC in people with The Focus of the Study is the Quality and Amount of Regenerated Articular Cartilage., run by Shetty-Kim Research Foundation at 1 site in United Kingdom.
Trial summary
Study Title: A study to compare two articular cartilage repair techniques in the knee joint: The use of Cultured Chondrocytes Vs. Cultured bone marrow aspiration cells. Study hypothesis: We start with the hypothesis that both treatments are equally effective. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- The Focus of the Study is the Quality and Amount of Regenerated Articular Cartilage.
- What is being tested?
- Cultured Chondrocytes and Cultured BMAC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Jun 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years to 65 years.
- Diagnosed with articular cartilage defect in the knee (ICRS/Outerbridge grade III/IV cartilage lesions as assessed on MRI scan).
- No other significant medical co-morbidities, as assessed by pre-operatively, that could interfere with surgery results of trial eg. Hypertension, COPD etc.
- Participant has clinically acceptable laboratory and ECG tests at pre-assessment clinic.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Up to 3 lesions of sizes 2-8 cm2
Who cannot join
- Generalized and/or inflammatory arthritis
- Active joint inflammation
- More than 5 degrees of varus or valgus deformity
- Age below 18 and over 65 years
- More than 4 lesions
- Lesions more than 8 cm2
- Significant co-morbidities or classified as ASA grade 3/4
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Kent Knee Unit
Walderslade, Kent, ME5 9PG
Vishvas A Shetty, MBBS, MCh, +44 1634 662813, vishvas.shetty@doctors.org.uk
Vishvas A Shetty, MBBS, MCh
About this study
Official title: Trial to Compare the Efficacy of Two Surgical Techniques for Articular Cartilage Repair in the Knee: The Use of Cultured Chondrocytes Vs. the Use of Cultured Bone Marrow Aspirate Cells.
Study Title: A study to compare two articular cartilage repair techniques in the knee joint: The use of Cultured Chondrocytes Vs. Cultured bone marrow aspiration cells.
Study hypothesis: We start with the hypothesis that both treatments are equally effective.
Read more
Trial Design: The participating patients will be divided into two groups, each group receiving either one of the treatment modalities. This study will not be randomised or blinded. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty, who is one half of the team that devised both techniques. The post-operative rehabilitation process will be the same for both groups.
Trial Participants: All participants will be from patients attending Professor Shetty's clinic at the Spire Alexandra Hospital.
Planned Sample Size: 50 patients in each group
Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm scores; cartilage growth will be measured by the MOCART score.
Planned Trial Period: Two to three years
Primary Objective: To establish superiority, if any, of either procedure over the other by studying pain relief, cartilage growth and improvement in function.
Primary Endpoint: At the end of the 2 year follow up for all participating patients.
Read the detailed description
BACKGROUND:
Articular cartilage repair in the knee is aimed at young patients with area(s) of cartilage loss and no deformity of the knee. These patients aren't indicated for a knee replacement. Articular cartilage repair leads to improvement of symptoms of pain, locking and function. Traditionally, articular cartilage repair has always involved exposing the entire knee joint with an arthrotomy. This, though effective, would lead to a large scar, longer hospital stay, longer rehabilitation and its associated complications. Also, the use of Bone Marrow Aspirate Cells (BMAC) for the purpose of cartilage repair has long been debated with both sides having valid arguments and good surgical results.
RATIONALE:
In our study, one method (Cultured Chondrocytes) requires an arthroscopy and an arthrotomy, takes 6 weeks to complete and is followed by 6 weeks of partial weight bearing on the operated leg. The other method (Cultured BMAC) is done arthroscopically, followed by 4 injections into the affected knee and takes 6 weeks to complete which includes 6 weeks of partial weight bearing on the operated leg.
Both procedures have shown encouraging results in terms of pain relief, cartilage growth and improved function. The use of cultured chondrocytes requires two surgeries and takes a total of 12 weeks till the patient can walk without support while the use of cultured BMAC involves only one surgery and can have the patient walking unsupported in 6 weeks. This study aims to ascertain if either technique is superior to the other.
If the cultured BMAC technique is shown to be superior, it could mean lesser surgery and faster recovery for the patient.
STUDY DESIGN: This study aims to compare two techniques of articular cartilage repair in the knee, namely the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The superiority will be assessed with by the certain scoring systems (IKDC, KOOS, Lysholm and MOCART) measured pre- and post-operatively.
Depending on which procedure the patient chooses to have, they will be allotted to either the cultured chondrocytes group or the cultured BMAC group. The patient is followed up in the clinic at the Spire Alexandra Hospital at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years following the surgery and their progress is documented by questionnaires and clinical examination. MRI scans are done at one and two years to assess the extent of cartilage growth.
SURGICAL TECHNIQUES
Cultured chondrocytes:
This method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. The entry ports are then closed and the knee is covered with a sterile dressing. The patient is transferred to the surgical recovery ward and, when medically stable, then transferred to their room on the ward. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for six weeks after the surgery. They also undergo five sessions of physiotherapy. Surgical clips and sutures are removed at 2 weeks following the surgery.
In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. The incision is then closed and the knee is covered with a sterile dressing. The patient is transferred to the surgical recovery ward and, when medically stable, then transferred to their room on the ward. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery. They also undergo 5 sessions of physiotherapy. Surgical clips and sutures are removed at 2 weeks following the surgery.
Cultured BMAC:
This method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. The entry ports are then closed and the knee is covered with a sterile dressing. The patient is transferred to the surgical recovery ward and, when medically stable, then transferred to their room on the ward. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for six weeks after the surgery. They also undergo five sessions of physiotherapy. Surgical clips and sutures are removed at 2 weeks following the surgery.
In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee.
Follow up: Patients in both arms will be followed up at 2,6,12,26,52 and 104 weeks following the end of the second stage of the procedure. Parameters noted will be pain relief, improvement in function and cartilage growth as assessed by MRI scans at one and two years.
- Being tested
- Cultured Chondrocytes, Cultured BMAC
- Keywords
- Articular cartilage, Chondrocytes, BMAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultured ChondrocytesProcedure or surgery
This method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery.
Cultured BMACProcedure or surgery
This method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee.
| Study group | Role | What they receive |
|---|---|---|
| Cultured chondrocytes | Active comparator | Cultured chondrocytes:
This method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery. Receives: Procedure: Cultured Chondrocytes |
| Cultured BMAC | Active comparator | This method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee. Receives: Procedure: Cultured BMAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
This study aims to compare two techniques of articular cartilage repair in the knee, namely the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The superiority will be assessed with by the IKDC, KOOS, Lysholm scores measured pre- and post-operatively.
Measured: 2 years
Radiological outcome
This study aims to compare two techniques of articular cartilage repair in the knee, namely the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The radiological superiority will be assessed with by MOCART scores measured pre- and post-operatively.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Focus of the Study is the Quality and Amount of Regenerated Articular Cartilage.Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shetty-Kim Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asode A Shetty, MD, MCh, PhD, FRCS, Principal investigator, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961973
- Sponsor's protocol ID
- ShettyKimRF 001
- Acronym
- Cultured
- Status last verified
- Oct 2013
- First submitted
- 10 Oct 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Compare the Efficacy of Two Surgical Techniques for Articular Cartilage Repair in the Knee: The Use of Cultured Chondrocytes Vs. the Use of Cultured Bone Marrow Aspirate Cells.
- ClinicalTrials.gov ID
- NCT01961973
- Acronym / sponsor ID
- Cultured / ShettyKimRF 001
- Keywords
- Articular cartilage, Chondrocytes, BMAC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shetty-Kim Research FoundationUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 14 Oct 2013 (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.
Study Title: A study to compare two articular cartilage repair techniques in the knee joint: The use of Cultured Chondrocytes Vs. Cultured bone marrow aspiration cells.
Study hypothesis: We start with the hypothesis that both treatments are equally effective.
Trial Design: The participating patients will be divided into two groups, each group receiving either one of the treatment modalities. This study will not be randomised or blinded. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty, who is one half of the team that devised both techniques. The post-operative rehabilitation process will be the same for both groups.
Trial Participants: All participants will be from patients attending Professor Shetty's clinic at the Spire Alexandra Hospital.
Planned Sample Size: 50 patients in each group
Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm scores; cartilage growth will be measured by the MOCART score.
Planned Trial Period: Two to three years
Primary Objective: To establish superiority, if any, of either procedure over the other by studying pain relief, cartilage growth and improvement in function.
Primary Endpoint: At the end of the 2 year follow up for all participating patients.
Detailed description
BACKGROUND:
Articular cartilage repair in the knee is aimed at young patients with area(s) of cartilage loss and no deformity of the knee. These patients aren't indicated for a knee replacement. Articular cartilage repair leads to improvement of symptoms of pain, locking and function. Traditionally, articular cartilage repair has always involved exposing the entire knee joint with an arthrotomy. This, though effective, would lead to a large scar, longer hospital stay, longer rehabilitation and its associated complications. Also, the use of Bone Marrow Aspirate Cells (BMAC) for the purpose of cartilage repair has long been debated with both sides having valid arguments and good surgical results.
RATIONALE:
In our study, one method (Cultured Chondrocytes) requires an arthroscopy and an arthrotomy, takes 6 weeks to complete and is followed by 6 weeks of partial weight bearing on the operated leg. The other method (Cultured BMAC) is done arthroscopically, followed by 4 injections into the affected knee and takes 6 weeks to complete which includes 6 weeks of partial weight bearing on the operated leg.
Both procedures have shown encouraging results in terms of pain relief, cartilage growth and improved function. The use of cultured chondrocytes requires two surgeries and takes a total of 12 weeks till the patient can walk without support while the use of cultured BMAC involves only one surgery and can have the patient walking unsupported in 6 weeks. This study aims to ascertain if either technique is superior to the other.
If the cultured BMAC technique is shown to be superior, it could mean lesser surgery and faster recovery for the patient.
STUDY DESIGN: This study aims to compare two techniques of articular cartilage repair in the knee, namely the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The superiority will be assessed with by the certain scoring systems (IKDC, KOOS, Lysholm and MOCART) measured pre- and post-operatively.
Depending on which procedure the patient chooses to have, they will be allotted to either the cultured chondrocytes group or the cultured BMAC group. The patient is followed up in the clinic at the Spire Alexandra Hospital at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years following the surgery and their progress is documented by questionnaires and clinical examination. MRI scans are done at one and two years to assess the extent of cartilage growth.
SURGICAL TECHNIQUES
Cultured chondrocytes:
This method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. The entry ports are then closed and the knee is covered with a sterile dressing. The patient is transferred to the surgical recovery ward and, when medically stable, then transferred to their room on the ward. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for six weeks after the surgery. They also undergo five sessions of physiotherapy. Surgical clips and sutures are removed at 2 weeks following the surgery.
In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. The incision is then closed and the knee is covered with a sterile dressing. The patient is transferred to the surgical recovery ward and, when medically stable, then transferred to their room on the ward. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery. They also undergo 5 sessions of physiotherapy. Surgical clips and sutures are removed at 2 weeks following the surgery.
Cultured BMAC:
This method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. The entry ports are then closed and the knee is covered with a sterile dressing. The patient is transferred to the surgical recovery ward and, when medically stable, then transferred to their room on the ward. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for six weeks after the surgery. They also undergo five sessions of physiotherapy. Surgical clips and sutures are removed at 2 weeks following the surgery.
In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee.
Follow up: Patients in both arms will be followed up at 2,6,12,26,52 and 104 weeks following the end of the second stage of the procedure. Parameters noted will be pain relief, improvement in function and cartilage growth as assessed by MRI scans at one and two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cultured chondrocytes | Active comparator | Procedure: Cultured ChondrocytesCultured chondrocytes: This method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery. |
| Cultured BMAC | Active comparator | Procedure: Cultured BMACThis method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years to 65 years.
- Diagnosed with articular cartilage defect in the knee (ICRS/Outerbridge grade III/IV cartilage lesions as assessed on MRI scan).
- No other significant medical co-morbidities, as assessed by pre-operatively, that could interfere with surgery results of trial eg. Hypertension, COPD etc.
- Participant has clinically acceptable laboratory and ECG tests at pre-assessment clinic.
Key exclusion criteria (7 listed)
- Generalized and/or inflammatory arthritis
- Active joint inflammation
- More than 5 degrees of varus or valgus deformity
- Age below 18 and over 65 years
- More than 4 lesions
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 |
|---|---|---|
| Cultured ChondrocytesThis method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery. | Procedure or surgery | Cultured chondrocytes |
| Cultured BMACThis method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee. | Procedure or surgery | Cultured BMAC |
Primary outcome
Clinical outcome
Time frame: 2 years
This study aims to compare two techniques of articular cartilage repair in the knee, namely the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The superiority will be assessed with by the IKDC, KOOS, Lysholm scores measured pre- and post-operatively.
Radiological outcome
Time frame: 2 years
This study aims to compare two techniques of articular cartilage repair in the knee, namely the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The radiological superiority will be assessed with by MOCART scores measured pre- and post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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.
Asode A Shetty, MD, MCh, PhD, FRCS principal investigator
Canterbury Christ Church University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cultured Chondrocytes and Cultured BMAC in people with The Focus of the Study is the Quality and Amount of Regenerated Articular Cartilage., run by Shetty-Kim Research Foundation at 1 site in United Kingdom.
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 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: status not confirmed, as of the sponsor's last update on 14 Oct 2013. 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 Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asode A Shetty, MD, PhD, MCh, FRCS (01634 662813, aashetty@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2013.