OsteoarthritisNCT01998308
Comparison Between Four Types of Single Dose Hyaluronic Acid Injection in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis, run by October 6 University at 1 site in Egypt.
Trial summary
Study design: Allocation: Randomized. Endpoint Classification: Comparative Study. Intervention model: Parallel Assignment. Masking: Double Blind (Subject, Assessed) Primary purpose: Comparison. Official Title: Intra-articular hyaluronic acid knee injection: randomized control trail. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Crespine gel, Intragel and Crespine plus gel
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2012to Dec 2019
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patient with knee osteoarthiritis
Who may be able to join
- Age of patients between 20 and 70 years
- patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading
Who cannot join
- Autoimmune illnesses
- Active inflammation or infected processes
- Anticoagulant
- Known allergy to hyaluronic acid.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
October 6 University
Six October City
Mahmoud A Hafez, Professor, 00201001116624, mhafez@msn.com
Abdullah I Ammoura, Researcher, 00201118581127, mixecano1991@gmail.com
About this study
Official title: Intra-articular Hyaluronic Acid Knee Injection: Randomized Control Trial.
Study design:
Allocation: Randomized. Endpoint Classification: Comparative Study. Intervention model: Parallel Assignment. Masking: Double Blind (Subject, Assessed) Primary purpose: Comparison.
Official Title: Intra-articular hyaluronic acid knee injection: randomized control trail.
Primary outcome measures:
- Lower extremity functional scale
- Visual analogue scale
- Range of motion
- Kellgren and Lawrence class grade Estimated enrollment: 100 Study start date: December 2012 Estimated study completion date: June 2013 Estimated primary completion date: December 2013
Read the detailed description
The study include:
200 knees, 50 knees will have single injection of Crespine gel, and 50 knees will have single injection of 2 ampules of Intragel, also 50 knees will have single injection of Crespine plus gel and 50 knees will have single injection of Monovisc The patient will be randomized to Crespine gel or to Intragel, and Crespine Plus gel or to Monovisc
Inclusion Criteria: patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading were included.
Exclusion Criteria: patients with autoimmune illnesses, active inflammation or infected processes, anticoagulant, and known allergy to hyaluronic acid.
Target parameters:
- Lower extremity functional scale
- Visual analogue scale
- Range of motion
- Kellgren and Lawrence class grade
Eligibility:
Ages Eligible for Study: 20 years to 70 years Genders Eligible for Study: both Accepts Healthy Volunteers: no
Criteria
Inclusion Criteria:
- Age of patients between 20 and 70 years
- patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading
Exclusion Criteria:
- Autoimmune illnesses
- Active inflammation or infected processes
- Anticoagulant
- Known allergy to hyaluronic acid.
- Conditions
- Osteoarthritis
- Being tested
- Crespine gel, Intragel, Crespine plus gel, Monovisc
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crespine gelDrug
50 Knees will have single injection of Crespine gel
IntragelDrug
50 Knees will have single injection of 2 ampules of Intragel
Crespine plus gelDrug
50 Knees will have single injection of Crespine Plus Gel
MonoviscDrug
50 Knees will have single injection of Monovisc
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 50 Knees will have single injection of Crespine gel Receives: Drug: Crespine gel | |
| Group 2 | 50 Knees will have single injection of 2 ampules of intragel Receives: Drug: Intragel | |
| Group 3 | 50 knees will have single injection of crespine plus gel Receives: Drug: Crespine plus gel | |
| Group 4 | 50 knees will have single injection of Monovisc Receives: Drug: Monovisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity functional scale
Measured: up to 52 weeks
Secondary outcomes (3)
Visual analog scale
Measured: up to 52 weeks
Kellgren and lawrence class grade
Measured: up to 52 weeks
Range of motion
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud A Hafez, MSc Orth, Dip SICOT, FRCS Ed, MD, October 6 University
- Investigators
- Mahmoud A Hafez, Professor, Principal investigator, October 6 UniversityAbdullah I Ammoura, Researcher, Study chair, Bone and Joint Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998308
- Sponsor's protocol ID
- October6U-0001
- Status last verified
- Sep 2015
- First submitted
- 16 Nov 2013
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Hyaluronic Acid Knee Injection: Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT01998308
- Acronym / sponsor ID
- October6U-0001
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Nov 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 design:
Allocation: Randomized. Endpoint Classification: Comparative Study. Intervention model: Parallel Assignment. Masking: Double Blind (Subject, Assessed) Primary purpose: Comparison.
Official Title: Intra-articular hyaluronic acid knee injection: randomized control trail.
Primary outcome measures:
- Lower extremity functional scale
- Visual analogue scale
- Range of motion
- Kellgren and Lawrence class grade Estimated enrollment: 100 Study start date: December 2012 Estimated study completion date: June 2013 Estimated primary completion date: December 2013
Detailed description
The study include:
200 knees, 50 knees will have single injection of Crespine gel, and 50 knees will have single injection of 2 ampules of Intragel, also 50 knees will have single injection of Crespine plus gel and 50 knees will have single injection of Monovisc The patient will be randomized to Crespine gel or to Intragel, and Crespine Plus gel or to Monovisc
Inclusion Criteria: patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading were included.
Exclusion Criteria: patients with autoimmune illnesses, active inflammation or infected processes, anticoagulant, and known allergy to hyaluronic acid.
Target parameters:
- Lower extremity functional scale
- Visual analogue scale
- Range of motion
- Kellgren and Lawrence class grade
Eligibility:
Ages Eligible for Study: 20 years to 70 years Genders Eligible for Study: both Accepts Healthy Volunteers: no
Criteria
Inclusion Criteria:
- Age of patients between 20 and 70 years
- patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading
Exclusion Criteria:
- Autoimmune illnesses
- Active inflammation or infected processes
- Anticoagulant
- Known allergy to hyaluronic acid.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Crespine gel50 Knees will have single injection of Crespine gel |
| Group 2 | – | Drug: Intragel50 Knees will have single injection of 2 ampules of intragel |
| Group 3 | – | Drug: Crespine plus gel50 knees will have single injection of crespine plus gel |
| Group 4 | – | Drug: Monovisc50 knees will have single injection of Monovisc |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patient with knee osteoarthiritis
Key inclusion criteria (2 listed)
- Age of patients between 20 and 70 years
- patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading
Key exclusion criteria (4 listed)
- Autoimmune illnesses
- Active inflammation or infected processes
- Anticoagulant
- Known allergy to hyaluronic acid.
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 |
|---|---|---|
| Crespine gel50 Knees will have single injection of Crespine gel | Drug | Group 1 |
| Intragel50 Knees will have single injection of 2 ampules of Intragel | Drug | Group 2 |
| Crespine plus gel50 Knees will have single injection of Crespine Plus Gel | Drug | Group 3 |
| Monovisc50 Knees will have single injection of Monovisc | Drug | Group 4 |
Primary outcome
Lower extremity functional scale
Time frame: up to 52 weeks
3 secondary outcomes
Visual analog scale
Time frame: up to 52 weeks
Kellgren and lawrence class grade
Time frame: up to 52 weeks
Range of motion
Time frame: up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
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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.
Mahmoud A Hafez, Professor principal investigator
October 6 University
Abdullah I Ammoura, Researcher study chair
Bone and Joint Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by October 6 University at 1 site in Egypt.
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 4 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 30 Sep 2015. 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 Egypt. 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 Mahmoud A Hafez, Professor (002 0100 1116624, mhafez@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity functional scale (time frame: up to 52 weeks). 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 30 Sep 2015.