Knee Pain ChronicNCT04313569
Arthroscopic Versus Conservative Treatment of Degenerative Meniscal Tear in Middle Aged Patients in Regard to Pain & Knee Function
A study testing Arthroscopic menisctomy in people with Knee Pain Chronic, run by Hawler Medical University at 1 site in Iraq.
Trial summary
The study is prospective comparative study, conducted in Erbil teaching hospital on 60 patients, their age ranging between 40 and 60 years. All were clinically diagnosed to have degenerative medial meniscal tear then confirmed by MRI. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- Arthroscopic menisctomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 1 Aug 2017to 30 Sep 2019
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Atraumatic continuous pain in medial aspect of knee affecting daily activities, for more than one month despite the treatment of general physician.
- Grade 3 degenerative tear of medial meniscus approved on MRI.
Who cannot join
- Meniscal tear due to trauma.
- Any rheumatologic knee disease.
- MRI showing ligament injury, loose bodies, tumors and osteochondral defects.
- Former surgery of knee and lower limb fractures in the last year.
- Knee joints with osteoarthritis graded 2 or more according to Kellgren-Lawrence scale (Kellgren and Lawrence, 1957) on weight-bearing knee x-ray.
- Lateral meniscus tear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Versus Conservative Treatment of Degenerative Meniscal Tear in Middle Aged Patients in Regard to Pain & Knee Function: Comparative Study
The study is prospective comparative study, conducted in Erbil teaching hospital on 60 patients, their age ranging between 40 and 60 years. All were clinically diagnosed to have degenerative medial meniscal tear then confirmed by MRI. Thirty patients were treated conservatively, thirty patients were treated arthroscopically.
- Conditions
- Knee Pain Chronic
- Being tested
- Arthroscopic menisctomy
- Keywords
- Degenerative meniscal tear, arthroscopic partial meniscectomy, conservative treatment, medial meniscal tear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic menisctomyProcedure or surgery
Arthroscopic medial menisctomy
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | No intervention | Use of medications, like analgesic, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAID) and local painkillers, depending on the patient condition, and physiotherapy, lifestyle and daily activity modification, patient education about positioning of the knee |
| Arthroscopic menisctomy | Other | Not described Receives: Procedure: Arthroscopic menisctomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm Knee Scoring Scale
Lysholm Knee score scale has (8) parts (swelling, pain, squatting, support, stair climbing, limping, locking and instability). Score of 100 means no problems in knee.
Measured: All patients were reviewed and evaluated one year, by Lysholm score
Visual analogue score
Ten points Visual Analogue Score scale used in order to meassure the severity of knee pain during the study. Zero meaning no pain while 10 meaning the most severe pain
Measured: All patients were reviewed and evaluated one year, by Visual Analogue score scales
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Aug 2017
- Primary completion1 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies 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
- Model description
- Arthroscopic meniscectomy
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwan Ahmed Ali Hamawandi, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313569
- Sponsor's protocol ID
- HMU/Sherwan9
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Versus Conservative Treatment of Degenerative Meniscal Tear in Middle Aged Patients in Regard to Pain & Knee Function: Comparative Study
- ClinicalTrials.gov ID
- NCT04313569
- Acronym / sponsor ID
- HMU/Sherwan9
- Conditions
- Knee Pain Chronic
- Keywords
- Degenerative meniscal tear, arthroscopic partial meniscectomy, conservative treatment, medial meniscal tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 18 Mar 2020 (actual)
- 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 study is prospective comparative study, conducted in Erbil teaching hospital on 60 patients, their age ranging between 40 and 60 years. All were clinically diagnosed to have degenerative medial meniscal tear then confirmed by MRI. Thirty patients were treated conservatively, thirty patients were treated arthroscopically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arthroscopic meniscectomy
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | No intervention | –Use of medications, like analgesic, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAID) and local painkillers, depending on the patient condition, and physiotherapy, lifestyle and daily activity modification, patient education about positioning of the knee |
| Arthroscopic menisctomy | Other | Procedure: Arthroscopic menisctomy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Atraumatic continuous pain in medial aspect of knee affecting daily activities, for more than one month despite the treatment of general physician.
- Grade 3 degenerative tear of medial meniscus approved on MRI.
Key exclusion criteria (6 listed)
- Meniscal tear due to trauma.
- Any rheumatologic knee disease.
- MRI showing ligament injury, loose bodies, tumors and osteochondral defects.
- Former surgery of knee and lower limb fractures in the last year.
- Knee joints with osteoarthritis graded 2 or more according to Kellgren-Lawrence scale (Kellgren and Lawrence, 1957) on weight-bearing knee x-ray.
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 |
|---|---|---|
| Arthroscopic menisctomyArthroscopic medial menisctomy | Procedure or surgery | Arthroscopic menisctomy |
Primary outcome
Lysholm Knee Scoring Scale
Time frame: All patients were reviewed and evaluated one year, by Lysholm score
Lysholm Knee score scale has (8) parts (swelling, pain, squatting, support, stair climbing, limping, locking and instability). Score of 100 means no problems in knee.
Visual analogue score
Time frame: All patients were reviewed and evaluated one year, by Visual Analogue score scales
Ten points Visual Analogue Score scale used in order to meassure the severity of knee pain during the study. Zero meaning no pain while 10 meaning the most severe pain
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 20 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic menisctomy in people with Knee Pain Chronic, run by Hawler Medical University at 1 site in Iraq.
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 20 Mar 2020. 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 Iraq. 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?
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?
Lysholm Knee Scoring Scale (time frame: All patients were reviewed and evaluated one year, by Lysholm score). 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 20 Mar 2020.