Torn MeniscusPhase 4MILENCT00613535
Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy
A Phase 4 study testing Mechanical debridement, Paragon T2 and Lavage debridement in people with Torn Meniscus, run by Smith & Nephew, Inc. at 10 sites in United States.
Trial summary
The aim of this study is to describe changes at the site of the study patient's articular cartilage lesion on the femoral condyle with multiple magnetic resonance imaging (MRI) outcomes 6 months after treatment using one of three standard surgical treatment methods: 1) lavage debridement; 2) mechanical debridement; 3)… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Torn Meniscus
- What is being tested?
- Mechanical debridement, Paragon T2 and Lavage debridement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2008to Jun 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- BMI <35
- Meniscal tear (medial or lateral) diagnosed by H+P exam and/or imaging in the index knee
- No severe joint space narrowing (IKDC Classification) seen on weight-bearing AP X-ray in the index knee
- No avascular necrosis in the index knee as evidenced by preop MRI obtained within 6 months prior to randomization
- No Varus (>10 degrees) or Valgus (>15 degrees)knee deformities as seen by AP X-ray in the index knee
Show all 15Show fewer
- Minimal or no abnormality of contralateral knee as shown by clinical exam and/or imaging
- Candidate for unilateral arthroscopic treatment of the knee
- Visual Analog Scale (VAS) pain score of 30 mm or greater in the index knee at the time of screening
- Must be able to undergo MRI at required time points per appendix D
- Physically and mentally willing and able to comply with study requirements
- Must be willing and able to follow the standardized rehabilitation protocol (Appendix C)
- Subject must sign IRB approved informed consent form
- Arthroscopy Inclusion Criteria:
- Arthroscopic confirmation of ICRS Grade II or III chondral lesion on the medial or lateral femoral condyle
Who cannot join
- Knee instability, malalignment, or patellar tracking dysfunction in the index knee
- Inflammatory rheumatoid arthritis or other systemic inflammatory arthritis in the index knee or contralateral knee
- Previous total meniscectomy in the index knee
- Previous surgical treatment of the index knee by arthroscopy less than 2 years prior to treatment by this study
- Previous total meniscectomy
- Previous knee tendon and/or ligament repair or patellar surgery of index knee
Show all 24Show fewer
- Previous microfracture or bone marrow stimulation of the index knee
- Previous unsuccessful osteotomy in the index knee
- Presence of fractures, osteocysts or osteolysis in the index knee
- Presence of osteoarthritis in the index knee
- Pre-existent osteoarthritis of weight-bearing joints (e.g. hips or contralateral knee) that adversely affects gait
- Participation in another clinical study
- Terminally ill
- Drug therapy for the index knee with systemic steroid therapy, steroid intra-articular therapy or intra-articular hyaluronic acid therapy within 2 months of enrollment into this study
- Receiving narcotic pain medication by prescription for other conditions unrelated to knee injury
- Contralateral knee involvement causing abnormal ambulation and non-compliance with rehabilitation
- Pregnant or suspected pregnant
- Coagulation disorder or patient is receiving anti-coagulants, which cannot be safely stopped for 14 days (7 days prior to surgery and 7 days post-surgery)
- Arthroscopy Exclusion Criteria:
- Presence of Grade IV chondromalacia anywhere in the index knee
- ACL, PCL or MCL tear of the index knee
- Osteochondritis dissecans (OCD)of the index knee
- Meniscal tear requiring total meniscectomy
- Evidence of osteoarthritis in the index knee
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Commonwealth Orthopaedics
Arlington, Virginia, 22205
Anderson Clinic
Arlington, Virginia, 22206
JDP Medical Research
Aurora, Colorado, 80014
Colorado Orthopedic Consultants, P.C.
Englewood, Colorado, 80110
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, 33316
Kerlan Jobe Orthopaedic Foundation
Los Angeles, California, 90045
Basin Orthopedic Surgical Specialists
Odessa, Texas, 79761
HOPE Research Institute
Phoenix, Arizona, 85050
University of Rochester Medical Center Department of Musculoskeletal Research
Rochester, New York, 14642
University of Mass. Memorial Medical Center
Worcester, Massachusetts, 01685
About this study
Official title: Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for Articular Cartilage Lesions Concomitant With Partial Meniscectomy
The aim of this study is to describe changes at the site of the study patient's articular cartilage lesion on the femoral condyle with multiple magnetic resonance imaging (MRI) outcomes 6 months after treatment using one of three standard surgical treatment methods: 1) lavage debridement; 2) mechanical debridement; 3) mechanical and radiofrequency-based debridement.
Read the detailed description
Fibrillated articular cartilage are commonly detected during arthroscopy when treating knee pathologies such as a torn meniscus or a damaged anterior cruciate ligament (ACL). The severity of these lesions is graded using a scheme such as the International Cartilage Research Society (ICRS) classification system. Grade I lesions are often left untreated, while Grade IV lesions require dedicated surgical intervention. Grade II and III lesions are frequently treated when they are encountered arthroscopically.
Currently, it is not known whether treatment of fibrillated articular cartilage is beneficial or whether one procedure is superior to another. Magnetic resonance imaging is the best technique currently available for non-invasive assessment of chondral lesions. The primary aim of the proposed study is to compare post-procedure MR imaging characteristics of fibrillated articular cartilage treated using one of the three standard of care measures: 1) Washing of the knee joint with saline solution to clear blood, fluid or loose tissue (also known as lavage); 2) Lavage in addition to mechanical shaver (a manual surgical tool used by the study doctor); and 3)Lavage in addition to the Paragon device (RF-based microdebridement), which may also be used with a mechanical (or manual) surgical tool. The secondary aim is to determine the association between imaging features and clinical outcomes.
- Conditions
- Torn Meniscus
- Being tested
- Mechanical debridement, Paragon T2, Lavage debridement, RF- based Debridement
- Keywords
- Partial Meniscectomy, Partial Thickness Knee Tear, MR Imaging, Mechanical Debridement, Crepitus, Stability, Coblation, Bipolar Radiofrequency, Debridement, Recurrent Knee Pain, meniscectomy, meniscus, cartilage lesion, articular cartilage lesion, articular cartilage, knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical debridementDevice
Mechanical shaver will be used to remove large chondral flaps and loose fragments
Paragon T2Device
Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.
Lavage debridementProcedure or surgery
Remove loose chondral fragments
Mechanical DebridementDevice
Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments
RF- based DebridementDevice
Use of debridement device to remove large fragments followed by use of RF-based debridement to smooth the base of the shoulder of the tear.
| Study group | Role | What they receive |
|---|---|---|
| Lavage debridement to remove loose fragments | Active comparator | Articular cartilage defect left untreated by surgical tool during partial meniscectomy Receives: Procedure: Lavage debridement |
| Mechanical Debridement | Active comparator | Remove large chondral flaps and loose fragments Receives: Device: Mechanical debridement |
| RF based Debridement | Active comparator | Debridement to remove loose fragments followed by use of Paragon T-2 RF wand to smooth the base of the shoulder of the tear Receives: Device: Paragon T2; Device: RF- based Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion
Measured: 6 months after arthroscopy
Secondary outcomes (1)
To determine whether recovery from recurrent pain, effusion, localized mechanical symptoms, and quality of life are equivalent for treatment groups
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: The correlation coefficient at the interim analysis with results for all three groups pooled, did not reach the level of statistical significance of (p\<0.05).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Torn MeniscusStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank A Pettrone, M.D., Principal investigator, Commonwealth Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613535
- Sponsor's protocol ID
- A-706-DHH
- Other IDs
- 1093528
- Acronym
- MILE
- Status last verified
- May 2015
- First submitted
- 31 Jan 2008
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Figueroa D, Calvo R, Vaisman A, Carrasco MA, Moraga C, Delgado I. Knee chondral lesions: incidence and correlation between arthroscopic and magnetic resonance findings. Arthroscopy. 2007 Mar;23(3):312-5. doi: 10.1016/j.arthro.2006.11.015.
PubMed 17349476Hjelle K, Solheim E, Strand T, Muri R, Brittberg M. Articular cartilage defects in 1,000 knee arthroscopies. Arthroscopy. 2002 Sep;18(7):730-4. doi: 10.1053/jars.2002.32839.
PubMed 12209430Widuchowski W, Widuchowski J, Trzaska T. Articular cartilage defects: study of 25,124 knee arthroscopies. Knee. 2007 Jun;14(3):177-82. doi: 10.1016/j.knee.2007.02.001. Epub 2007 Apr 10.
PubMed 17428666Sgaglione NA, Miniaci A, Gillogly SD, Carter TR. Update on advanced surgical techniques in the treatment of traumatic focal articular cartilage lesions in the knee. Arthroscopy. 2002 Feb;18(2 Suppl 1):9-32. doi: 10.1053/jars.2002.31783.
PubMed 11828343Brittberg M, Winalski CS. Evaluation of cartilage injuries and repair. J Bone Joint Surg Am. 2003;85-A Suppl 2:58-69. doi: 10.2106/00004623-200300002-00008. No abstract available.
PubMed 12721346Shelbourne KD, Jari S, Gray T. Outcome of untreated traumatic articular cartilage defects of the knee: a natural history study. J Bone Joint Surg Am. 2003;85-A Suppl 2:8-16. doi: 10.2106/00004623-200300002-00002.
PubMed 12721340Alford JW, Cole BJ. Cartilage restoration, part 1: basic science, historical perspective, patient evaluation, and treatment options. Am J Sports Med. 2005 Feb;33(2):295-306. doi: 10.1177/0363546504273510.
PubMed 15701618Messner K, Maletius W. The long-term prognosis for severe damage to weight-bearing cartilage in the knee: a 14-year clinical and radiographic follow-up in 28 young athletes. Acta Orthop Scand. 1996 Apr;67(2):165-8. doi: 10.3109/17453679608994664.
PubMed 8623573Fowler P. Arthroscopic lavage or debridement did not reduce pain more than placebo did in patients with osteoarthritis. J Bone Joint Surg Am. 2003 Feb;85(2):387. doi: 10.2106/00004623-200302000-00038. No abstract available.
PubMed 12571328Owens BD, Stickles BJ, Balikian P, Busconi BD. Prospective analysis of radiofrequency versus mechanical debridement of isolated patellar chondral lesions. Arthroscopy. 2002 Feb;18(2):151-5. doi: 10.1053/jars.2002.29906.
PubMed 11830808Barber FA, Iwasko NG. Treatment of grade III femoral chondral lesions: mechanical chondroplasty versus monopolar radiofrequency probe. Arthroscopy. 2006 Dec;22(12):1312-7. doi: 10.1016/j.arthro.2006.06.008.
PubMed 17157730Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20. doi: 10.2106/JBJS.D.02846.
PubMed 16140804Henderson IJ, Tuy B, Connell D, Oakes B, Hettwer WH. Prospective clinical study of autologous chondrocyte implantation and correlation with MRI at three and 12 months. J Bone Joint Surg Br. 2003 Sep;85(7):1060-6. doi: 10.1302/0301-620x.85b7.13782.
PubMed 14516048Voloshin I, Morse KR, Allred CD, Bissell SA, Maloney MD, DeHaven KE. Arthroscopic evaluation of radiofrequency chondroplasty of the knee. Am J Sports Med. 2007 Oct;35(10):1702-7. doi: 10.1177/0363546507304328. Epub 2007 Jul 20.
PubMed 17644661Yetkinler DN, Greenleaf JE, Sherman OH. Histologic analysis of radiofrequency energy chondroplasty. Clin Sports Med. 2002 Oct;21(4):649-61, viii. doi: 10.1016/s0278-5919(02)00015-7.
PubMed 12489295
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for Articular Cartilage Lesions Concomitant With Partial Meniscectomy
- ClinicalTrials.gov ID
- NCT00613535
- Acronym / sponsor ID
- MILE / A-706-DHH
- Conditions
- Torn Meniscus
- Keywords
- Partial Meniscectomy, Partial Thickness Knee Tear, MR Imaging, Mechanical Debridement, Crepitus, Stability, Coblation, Bipolar Radiofrequency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The correlation coefficient at the interim analysis with results for all three groups pooled, did not reach the level of statistical significance of (p\<0.05).
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Feb 2008 (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 aim of this study is to describe changes at the site of the study patient's articular cartilage lesion on the femoral condyle with multiple magnetic resonance imaging (MRI) outcomes 6 months after treatment using one of three standard surgical treatment methods: 1) lavage debridement; 2) mechanical debridement; 3) mechanical and radiofrequency-based debridement.
Detailed description
Fibrillated articular cartilage are commonly detected during arthroscopy when treating knee pathologies such as a torn meniscus or a damaged anterior cruciate ligament (ACL). The severity of these lesions is graded using a scheme such as the International Cartilage Research Society (ICRS) classification system. Grade I lesions are often left untreated, while Grade IV lesions require dedicated surgical intervention. Grade II and III lesions are frequently treated when they are encountered arthroscopically.
Currently, it is not known whether treatment of fibrillated articular cartilage is beneficial or whether one procedure is superior to another. Magnetic resonance imaging is the best technique currently available for non-invasive assessment of chondral lesions. The primary aim of the proposed study is to compare post-procedure MR imaging characteristics of fibrillated articular cartilage treated using one of the three standard of care measures: 1) Washing of the knee joint with saline solution to clear blood, fluid or loose tissue (also known as lavage); 2) Lavage in addition to mechanical shaver (a manual surgical tool used by the study doctor); and 3)Lavage in addition to the Paragon device (RF-based microdebridement), which may also be used with a mechanical (or manual) surgical tool. The secondary aim is to determine the association between imaging features and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lavage debridement to remove loose fragments | Active comparator | Procedure: Lavage debridementArticular cartilage defect left untreated by surgical tool during partial meniscectomy |
| Mechanical Debridement | Active comparator | Device: Mechanical debridementRemove large chondral flaps and loose fragments |
| RF based Debridement | Active comparator | Device: Paragon T2, Device: RF- based DebridementDebridement to remove loose fragments followed by use of Paragon T-2 RF wand to smooth the base of the shoulder of the tear |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Age between 18 and 60 years
- BMI <35
- Meniscal tear (medial or lateral) diagnosed by H+P exam and/or imaging in the index knee
- No severe joint space narrowing (IKDC Classification) seen on weight-bearing AP X-ray in the index knee
- No avascular necrosis in the index knee as evidenced by preop MRI obtained within 6 months prior to randomization
Key exclusion criteria (24 listed)
- Knee instability, malalignment, or patellar tracking dysfunction in the index knee
- Inflammatory rheumatoid arthritis or other systemic inflammatory arthritis in the index knee or contralateral knee
- Previous total meniscectomy in the index knee
- Previous surgical treatment of the index knee by arthroscopy less than 2 years prior to treatment by this study
- Previous total meniscectomy
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 |
|---|---|---|
| Mechanical debridementMechanical shaver will be used to remove large chondral flaps and loose fragments | Device | Mechanical Debridement |
| Paragon T2Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver. | Device | RF based Debridement |
| Lavage debridementRemove loose chondral fragments | Procedure or surgery | Lavage debridement to remove loose fragments |
| Mechanical DebridementUse of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments | Device | Mechanical Debridement |
| RF- based DebridementUse of debridement device to remove large fragments followed by use of RF-based debridement to smooth the base of the shoulder of the tear. | Device | RF based Debridement |
Primary outcome
In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion
Time frame: 6 months after arthroscopy
1 secondary outcome
To determine whether recovery from recurrent pain, effusion, localized mechanical symptoms, and quality of life are equivalent for treatment groups
Time frame: Up to 24 months
Results and safety
The study was stopped early (reason given: The correlation coefficient at the interim analysis with results for all three groups pooled, did not reach the level of statistical significance of (p\<0.05).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Background: PubMed 17349476Figueroa D, Calvo R, Vaisman A, Carrasco MA, Moraga C, Delgado I. Knee chondral lesions: incidence and correlation between arthroscopic and magnetic resonance findings. Arthroscopy. 2007 Mar;23(3):312-5. doi: 10.1016/j.arthro.2006.11.015.
- Background: PubMed 12209430Hjelle K, Solheim E, Strand T, Muri R, Brittberg M. Articular cartilage defects in 1,000 knee arthroscopies. Arthroscopy. 2002 Sep;18(7):730-4. doi: 10.1053/jars.2002.32839.
- Background: PubMed 17428666Widuchowski W, Widuchowski J, Trzaska T. Articular cartilage defects: study of 25,124 knee arthroscopies. Knee. 2007 Jun;14(3):177-82. doi: 10.1016/j.knee.2007.02.001. Epub 2007 Apr 10.
- Background: PubMed 11828343Sgaglione NA, Miniaci A, Gillogly SD, Carter TR. Update on advanced surgical techniques in the treatment of traumatic focal articular cartilage lesions in the knee. Arthroscopy. 2002 Feb;18(2 Suppl 1):9-32. doi: 10.1053/jars.2002.31783.
- Background: PubMed 12721346Brittberg M, Winalski CS. Evaluation of cartilage injuries and repair. J Bone Joint Surg Am. 2003;85-A Suppl 2:58-69. doi: 10.2106/00004623-200300002-00008. No abstract available.
- Background: PubMed 12721340Shelbourne KD, Jari S, Gray T. Outcome of untreated traumatic articular cartilage defects of the knee: a natural history study. J Bone Joint Surg Am. 2003;85-A Suppl 2:8-16. doi: 10.2106/00004623-200300002-00002.
- Background: PubMed 15701618Alford JW, Cole BJ. Cartilage restoration, part 1: basic science, historical perspective, patient evaluation, and treatment options. Am J Sports Med. 2005 Feb;33(2):295-306. doi: 10.1177/0363546504273510.
- Background: PubMed 8623573Messner K, Maletius W. The long-term prognosis for severe damage to weight-bearing cartilage in the knee: a 14-year clinical and radiographic follow-up in 28 young athletes. Acta Orthop Scand. 1996 Apr;67(2):165-8. doi: 10.3109/17453679608994664.
- Background: PubMed 12571328Fowler P. Arthroscopic lavage or debridement did not reduce pain more than placebo did in patients with osteoarthritis. J Bone Joint Surg Am. 2003 Feb;85(2):387. doi: 10.2106/00004623-200302000-00038. No abstract available.
- Background: PubMed 11830808Owens BD, Stickles BJ, Balikian P, Busconi BD. Prospective analysis of radiofrequency versus mechanical debridement of isolated patellar chondral lesions. Arthroscopy. 2002 Feb;18(2):151-5. doi: 10.1053/jars.2002.29906.
- Background: PubMed 17157730Barber FA, Iwasko NG. Treatment of grade III femoral chondral lesions: mechanical chondroplasty versus monopolar radiofrequency probe. Arthroscopy. 2006 Dec;22(12):1312-7. doi: 10.1016/j.arthro.2006.06.008.
- Background: PubMed 16140804Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20. doi: 10.2106/JBJS.D.02846.
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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.
Frank A Pettrone, M.D. principal investigator
Commonwealth Orthopaedics
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mechanical debridement, Paragon T2 and Lavage debridement in people with Torn Meniscus, run by Smith & Nephew, Inc. at 10 sites 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 15 inclusion and 24 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: stopped early, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. 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 was stopped early (reason given: The correlation coefficient at the interim analysis with results for all three groups pooled, did not reach the level of statistical significance of (p\<0.05).). Results are not available in the source record.
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?
In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion (time frame: 6 months after arthroscopy). 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 NCT00613535, which also lists 15 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 19 May 2015.