Arthroscopic SurgeryNCT01254682
Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist
A study testing Ostenil and Standard arthroscopic procedure in people with Arthroscopic Surgery, run by TRB Chemedica AG at 1 site in Germany.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroscopic Surgery
- What is being tested?
- Ostenil and Standard arthroscopic procedure
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Aug 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between 18 and 80 years of age
- Minimum pain score of 2 according to modified Mayo Wrist Score
- Patients in good general health/nutritional condition
- Signed written informed consent
Who cannot join
- Alcohol / drug abuse, drug addiction or neurotic personality disorder; patients with mental illness or suicidal tendency
- Severe intercurrent illness (like uncontrolled diabetes mellitus or thyroid disease, carcinoma,...)
- Fertile women without medically secured contraception(hysterectomy, sterilization, contraceptives,...)
- Subjects having a high probability of non compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient German linguistic knowledge)
- Contraindication for the use of one of the investigational products or for the scheduled anesthesia
- Concomitant or previous participation in a clinical trial within the last 3 months
Show all 9Show fewer
- Intraarticular treatment with a sodium hyaluronate-based product within the last 6 months
- Intraarticular treatment by the use of corticoid containing substance within the last 3 months
- Concomitant illness or injury influencing study evaluation
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist.
- Conditions
- Arthroscopic Surgery
- Being tested
- Ostenil, Standard arthroscopic procedure
- Keywords
- wrist, joint, arthroscopy, hyaluronan, hyaluronic acid, Necessity of Arthroscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OstenilDevice
Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment). Add-on treatment with Ostenil after standard arthroscopic procedure. Application twice: first injection directly after arthroscopic procedure and second injection 3 weeks post arthroscopic.
Standard arthroscopic procedureProcedure or surgery
Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment) without add-on treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid sodium salt (1%, 20mg/2ml) | Active comparator | Not described Receives: Device: Ostenil |
| Standard arthroscopic procedure | Other | Not described Receives: Procedure: Standard arthroscopic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery.
Mayo wrist score evaluation consisting of 4 sections:
- Maximal grip strength on injured side (compared to maximal strength of contralateral side, measured by 4-point scale, ranking from '0' for minimal to '30' for maximal strength)
- Range of motion (measured by 4-point scale, ranking from '0' for minimal to '20' for maximal mobility)
- Pain (measured by 4-point scale, ranking from '0' for maximal to '20' for minimal pain)
- Function in daily activities (measured by 4-point scale, ranking from '0' for minimal to '30' for maximal function)
Measured: Baseline and 3 months
Secondary outcomes (7)
Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment.
Measured: Measured during the 6-month duration of participation
Disabilities of the arm, shoulder, and hand (DASH) outcome measure
Measured: Measured during the 6-month duration of participation
Grip strength
Measured: Measured during the 6-month duration of participation
Visual analogue scale of pain (VAS; 100 mm)
Measured: Measured during the 6-month duration of participation
Clinical Global Impression (CGI)
Measured: Measured during the 6-month duration of participation
Inter-group comparison of Mayo wrist subscores in subjects with or without post-arthroscopic hyaluronan treatment.
- Maximal grip strength on injured side (compared to contralateral side)
- Range of motion
- Pain
- Function in daily activities
Measured: Measured during the 6-month duration of participation
Number of subjects with Adverse Events as a measure of safety and tolerability
Measured: Measured during the 6-month duration of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startJan 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic SurgeryStudies 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
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Schütz, Dr. med., Principal investigator, Orthopädische Gemeinschaftspraxis, Straubing (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254682
- Sponsor's protocol ID
- OSTWA-07-01
- Status last verified
- Sep 2011
- First submitted
- 22 Nov 2010
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist
- ClinicalTrials.gov ID
- NCT01254682
- Acronym / sponsor ID
- OSTWA-07-01
- Conditions
- Arthroscopic Surgery
- Keywords
- wrist, joint, arthroscopy, hyaluronan, hyaluronic acid, Necessity of Arthroscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 6 Dec 2010 (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 primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid sodium salt (1%, 20mg/2ml) | Active comparator | Device: Ostenil |
| Standard arthroscopic procedure | Other | Procedure: Standard arthroscopic procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients between 18 and 80 years of age
- Minimum pain score of 2 according to modified Mayo Wrist Score
- Patients in good general health/nutritional condition
- Signed written informed consent
Key exclusion criteria (9 listed)
- Alcohol / drug abuse, drug addiction or neurotic personality disorder; patients with mental illness or suicidal tendency
- Severe intercurrent illness (like uncontrolled diabetes mellitus or thyroid disease, carcinoma,...)
- Fertile women without medically secured contraception(hysterectomy, sterilization, contraceptives,...)
- Subjects having a high probability of non compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient German linguistic knowledge)
- Contraindication for the use of one of the investigational products or for the scheduled anesthesia
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 |
|---|---|---|
| OstenilStandard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment). Add-on treatment with Ostenil after standard arthroscopic procedure. Application twice: first injection directly after arthroscopic procedure and second injection 3 weeks post arthroscopic. | Device | Hyaluronic acid sodium salt (1%, 20mg/2ml) |
| Standard arthroscopic procedureStandard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment) without add-on treatment. | Procedure or surgery | Standard arthroscopic procedure |
Primary outcome
Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery.
Time frame: Baseline and 3 months
Mayo wrist score evaluation consisting of 4 sections: * Maximal grip strength on injured side (compared to maximal strength of contralateral side, measured by 4-point scale, ranking from '0' for minimal to '30' for maximal strength) * Range of motion (measured by 4-point scale, ranking from '0' for minimal to '20' for maximal mobility) * Pain (measured by 4-point scale, ranking from '0' for maximal to '20' for minimal pain) * Function in daily activities (measured by 4-point scale, ranking from '0' for minimal to '30' for maximal function)
7 secondary outcomes
Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment.
Time frame: Measured during the 6-month duration of participation
Disabilities of the arm, shoulder, and hand (DASH) outcome measure
Time frame: Measured during the 6-month duration of participation
Grip strength
Time frame: Measured during the 6-month duration of participation
Visual analogue scale of pain (VAS; 100 mm)
Time frame: Measured during the 6-month duration of participation
Clinical Global Impression (CGI)
Time frame: Measured during the 6-month duration of participation
Inter-group comparison of Mayo wrist subscores in subjects with or without post-arthroscopic hyaluronan treatment.
Time frame: Measured during the 6-month duration of participation
Number of subjects with Adverse Events as a measure of safety and tolerability
Time frame: Measured during the 6-month duration of participation
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 28 Sep 2011.
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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.
Alexander Schütz, Dr. med. principal investigator
Orthopädische Gemeinschaftspraxis, Straubing (Germany)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ostenil and Standard arthroscopic procedure in people with Arthroscopic Surgery, run by TRB Chemedica AG at 1 site in Germany.
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 4 inclusion and 9 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 28 Sep 2011. 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 Germany. 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?
Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery. (time frame: Baseline and 3 months). 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 28 Sep 2011.