Osteoarthritis, KneeNCT00549172
Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear
A study testing Operative (partial arthroscopy) and Conservative (diagnostic arthroscopy) in people with Osteoarthritis, Knee, run by Tampere University at 5 sites in Finland.
Trial summary
Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Operative (partial arthroscopy) and Conservative (diagnostic arthroscopy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 5 sitesFinland
- Study dates
- Oct 2007to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 35 to 65 years of age.
- A pain located on the medial joint line of the knee that has persistent at least for 3 months.
- Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.
- Tear of the medial meniscus on MRI.
- Degenerative rupture of the medial meniscus confirmed at arthroscopy.
Who cannot join
- Acute, trauma-induced onset of symptoms.
- Locking or painful snapping of the knee joint.
- A surgical operation performed on the affected knee.
- Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR).
- Osteoarthritis on knee radiographs (Kellgren-Lawrence > 1).
- Acute (within the previous year) fractures of the knee.
Show all 10Show fewer
- Decreased range of motion of the knee.
- Instability of the knee.
- MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment.
- Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Helsinki Central Hospital
Helsinki
Central Finland Hospital District
Jyväskylä
Kuopio University Hospital
Kuopio
Hatanpää City Hospital
Tampere, FI-33101
Turku University Hospital
Turku
About this study
Official title: Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee
Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison exist. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial.
Read the detailed description
Middle-aged men and women with degenerative meniscal tears constitute a large group of patients presenting with knee pain, sometimes accompanied with swelling and loss of function. Many meniscal tears occur without a trauma in physically active individuals as well as in older people and could be a part of early osteoarthritis. Partial arthroscopic meniscectomy is the most common orthopaedic procedure and is used to treat patients with meniscal tears. Many patients report improvement after arthroscopy referring especially to reduced knee pain, better knee function and improved quality of life. However, similar results have also been obtained with conservative treatment (physical therapy) of patients with degenerative meniscal tears. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial. The outcome of arthroscopic partial meniscectomy (vs. sham surgery) is assessed using the Lysholm knee score and pain at rest and activity (VAS) at 2, 6 and 12 months after the operation. In addition, the functional outcome is assessed using the WOMET knee score (a disease-specific quality of life -knee score development on the assessment of meniscal pathology), the general quality of life score (15-D), and cost-effectiveness analysis.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Operative (partial arthroscopy), Conservative (diagnostic arthroscopy)
- Keywords
- Osteoarthritis, Knee, Arthroscopic Surgery, Menisci, Medial, Placebo Effect, Treatment Efficacy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative (partial arthroscopy)Procedure or surgery
Partial arthroscopic resection of degenerative rupture of the medial meniscus
Conservative (diagnostic arthroscopy)Procedure or surgery
Diagnostic arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Operative (O) | Active comparator | Partial resection of degenerative tear of medial meniscus Receives: Procedure: Operative (partial arthroscopy) |
| Conservative (K) | Sham comparator | Arthroscopy (diagnostic) Receives: Procedure: Conservative (diagnostic arthroscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Lysholm Knee Score
The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.
Measured: One year
Pain After Exercise (VAS)
Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
Measured: One year
WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)
The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score.
Measured: One year
Secondary outcomes (3)
15-D (General Quality of Life -Assessment Tool)
The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).
Measured: One year
Pain at Rest (VAS)
Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
Measured: One year
Cost Effectiveness
Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kuopio University Hospital, Turku University Hospital, Central Finland Hospital District
- Responsible party
- Principal investigator, Raine Sihvonen, Tampere University
- Investigators
- Teppo LN Jarvinen, MD, PhD, Study chair, Tampere UniversityRaine TA Sihvonen, MD, Principal investigator, Tampere City HospitalMika Paavola, MD, PhD, Study director, University of HelsinkiAntti Malmivaara, MD, PhD, Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549172
- Sponsor's protocol ID
- R06157
- Status last verified
- Dec 2022
- First submitted
- 24 Oct 2007
- Last updated
- 13 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kalske R, Sihvonen R, Karjalainen TV, Juurakko J, Ibounig T, Ramo L, Kanto K, Lahdeoja T, Jokihaara J, Paavola M, Toivonen P, Taimela S, Jarvinen TL. Minimal important difference and patient acceptable symptom state for Lysholm score, WOMET score, and pain in patients with arthroscopy for a degenerative meniscus tear. BMC Med Res Methodol. 2026 Jul 29;26(1):228. doi: 10.1186/s12874-026-02958-2.
PubMed 42934515Sillanpaa N, Iivanainen M, Turkiewicz A, Sihvonen R, Paavola M, Taimela S, Jarvinen TLN, Englund M. Effect of arthroscopic partial meniscectomy on structural degeneration of the knee - A 5-year MRI-based follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Osteoarthritis Cartilage. 2025 Feb;33(2):276-282. doi: 10.1016/j.joca.2024.09.003. Epub 2024 Sep 12.
PubMed 39277028Kalske R, Kiadaliri A, Sihvonen R, Englund M, Turkiewicz A, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Toivonen P, Taimela S, Jarvinen TLN; FIDELITY (Finnish Degenerative Meniscal Lesion Study) Investigators. Arthroscopic Partial Meniscectomy for a Degenerative Meniscus Tear Is Not Cost Effective Compared With Placebo Surgery: An Economic Evaluation Based on the FIDELITY Trial Data. Clin Orthop Relat Res. 2024 Sep 1;482(9):1523-1533. doi: 10.1097/CORR.0000000000003094. Epub 2024 May 7.
PubMed 38905520Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Kalske J, Nurmi H, Kumm J, Sillanpaa N, Kiekara T, Turkiewicz A, Toivonen P, Englund M, Taimela S, Jarvinen TLN; FIDELITY (Finnish Degenerative Meniscus Lesion Study) Investigators. Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Br J Sports Med. 2020 Nov;54(22):1332-1339. doi: 10.1136/bjsports-2020-102813. Epub 2020 Aug 27.
PubMed 32855201Sihvonen R, Kalske R, Englund M, Turkiewicz A, Toivonen P, Taimela S, Jarvinen TLN; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Investigators. Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial. Trials. 2020 Jan 14;21(1):76. doi: 10.1186/s13063-019-3833-2.
PubMed 31937344Sihvonen R, Englund M, Turkiewicz A, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study Group. Mechanical Symptoms and Arthroscopic Partial Meniscectomy in Patients With Degenerative Meniscus Tear: A Secondary Analysis of a Randomized Trial. Ann Intern Med. 2016 Apr 5;164(7):449-55. doi: 10.7326/M15-0899. Epub 2016 Feb 9.
PubMed 26856620Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Kalske J, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013 Dec 26;369(26):2515-24. doi: 10.1056/NEJMoa1305189.
PubMed 24369076Sihvonen R, Paavola M, Malmivaara A, Jarvinen TL. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design. BMJ Open. 2013 Mar 9;3(3):e002510. doi: 10.1136/bmjopen-2012-002510.
PubMed 23474796
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee
- ClinicalTrials.gov ID
- NCT00549172
- Acronym / sponsor ID
- R06157
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Arthroscopic Surgery, Menisci, Medial, Placebo Effect, Treatment Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kuopio University Hospital, Turku University Hospital, Central Finland Hospital District
- Study start
- Oct 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Oct 2007 (estimated)
- Results
- Posted 23 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison exist. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial.
Detailed description
Middle-aged men and women with degenerative meniscal tears constitute a large group of patients presenting with knee pain, sometimes accompanied with swelling and loss of function. Many meniscal tears occur without a trauma in physically active individuals as well as in older people and could be a part of early osteoarthritis. Partial arthroscopic meniscectomy is the most common orthopaedic procedure and is used to treat patients with meniscal tears. Many patients report improvement after arthroscopy referring especially to reduced knee pain, better knee function and improved quality of life. However, similar results have also been obtained with conservative treatment (physical therapy) of patients with degenerative meniscal tears. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial. The outcome of arthroscopic partial meniscectomy (vs. sham surgery) is assessed using the Lysholm knee score and pain at rest and activity (VAS) at 2, 6 and 12 months after the operation. In addition, the functional outcome is assessed using the WOMET knee score (a disease-specific quality of life -knee score development on the assessment of meniscal pathology), the general quality of life score (15-D), and cost-effectiveness analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative (O) | Active comparator | Procedure: Operative (partial arthroscopy)Partial resection of degenerative tear of medial meniscus |
| Conservative (K) | Sham comparator | Procedure: Conservative (diagnostic arthroscopy)Arthroscopy (diagnostic) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 35 to 65 years of age.
- A pain located on the medial joint line of the knee that has persistent at least for 3 months.
- Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.
- Tear of the medial meniscus on MRI.
- Degenerative rupture of the medial meniscus confirmed at arthroscopy.
Key exclusion criteria (10 listed)
- Acute, trauma-induced onset of symptoms.
- Locking or painful snapping of the knee joint.
- A surgical operation performed on the affected knee.
- Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR).
- Osteoarthritis on knee radiographs (Kellgren-Lawrence > 1).
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 |
|---|---|---|
| Operative (partial arthroscopy)Partial arthroscopic resection of degenerative rupture of the medial meniscus | Procedure or surgery | Operative (O) |
| Conservative (diagnostic arthroscopy)Diagnostic arthroscopy | Procedure or surgery | Conservative (K) |
Primary outcome
The Lysholm Knee Score
Time frame: One year
The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.
Pain After Exercise (VAS)
Time frame: One year
Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)
Time frame: One year
The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score.
3 secondary outcomes
15-D (General Quality of Life -Assessment Tool)
Time frame: One year
Pain at Rest (VAS)
Time frame: One year
Cost Effectiveness
Time frame: 1 and 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42934515Kalske R, Sihvonen R, Karjalainen TV, Juurakko J, Ibounig T, Ramo L, Kanto K, Lahdeoja T, Jokihaara J, Paavola M, Toivonen P, Taimela S, Jarvinen TL. Minimal important difference and patient acceptable symptom state for Lysholm score, WOMET score, and pain in patients with arthroscopy for a degenerative meniscus tear. BMC Med Res Methodol. 2026 Jul 29;26(1):228. doi: 10.1186/s12874-026-02958-2.
- Derived from this study: PubMed 39277028Sillanpaa N, Iivanainen M, Turkiewicz A, Sihvonen R, Paavola M, Taimela S, Jarvinen TLN, Englund M. Effect of arthroscopic partial meniscectomy on structural degeneration of the knee - A 5-year MRI-based follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Osteoarthritis Cartilage. 2025 Feb;33(2):276-282. doi: 10.1016/j.joca.2024.09.003. Epub 2024 Sep 12.
- Derived from this study: PubMed 38905520Kalske R, Kiadaliri A, Sihvonen R, Englund M, Turkiewicz A, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Toivonen P, Taimela S, Jarvinen TLN; FIDELITY (Finnish Degenerative Meniscal Lesion Study) Investigators. Arthroscopic Partial Meniscectomy for a Degenerative Meniscus Tear Is Not Cost Effective Compared With Placebo Surgery: An Economic Evaluation Based on the FIDELITY Trial Data. Clin Orthop Relat Res. 2024 Sep 1;482(9):1523-1533. doi: 10.1097/CORR.0000000000003094. Epub 2024 May 7.
- Derived from this study: PubMed 32855201Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Kalske J, Nurmi H, Kumm J, Sillanpaa N, Kiekara T, Turkiewicz A, Toivonen P, Englund M, Taimela S, Jarvinen TLN; FIDELITY (Finnish Degenerative Meniscus Lesion Study) Investigators. Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Br J Sports Med. 2020 Nov;54(22):1332-1339. doi: 10.1136/bjsports-2020-102813. Epub 2020 Aug 27.
- Derived from this study: PubMed 31937344Sihvonen R, Kalske R, Englund M, Turkiewicz A, Toivonen P, Taimela S, Jarvinen TLN; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Investigators. Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial. Trials. 2020 Jan 14;21(1):76. doi: 10.1186/s13063-019-3833-2.
- Derived from this study: PubMed 26856620Sihvonen R, Englund M, Turkiewicz A, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study Group. Mechanical Symptoms and Arthroscopic Partial Meniscectomy in Patients With Degenerative Meniscus Tear: A Secondary Analysis of a Randomized Trial. Ann Intern Med. 2016 Apr 5;164(7):449-55. doi: 10.7326/M15-0899. Epub 2016 Feb 9.
- Derived from this study: PubMed 24369076Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Kalske J, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013 Dec 26;369(26):2515-24. doi: 10.1056/NEJMoa1305189.
- Derived from this study: PubMed 23474796Sihvonen R, Paavola M, Malmivaara A, Jarvinen TL. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design. BMJ Open. 2013 Mar 9;3(3):e002510. doi: 10.1136/bmjopen-2012-002510.
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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.
Teppo LN Jarvinen, MD, PhD study chair
Tampere University
Raine TA Sihvonen, MD principal investigator
Tampere City Hospital
Mika Paavola, MD, PhD study director
University of Helsinki
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative (partial arthroscopy) and Conservative (diagnostic arthroscopy) in people with Osteoarthritis, Knee, run by Tampere University at 5 sites in Finland.
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 5 inclusion and 10 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 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Lysholm Knee Score (time frame: One year). The study lists 3 primary outcomes in all. 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 NCT00549172, which also lists 8 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 Jan 2023.