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NCT01254682
Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist
NA trial testing Ostenil in Arthroscopic Surgery in 140 participants. Completed in 1 August 2009.
1 August 2009
Quick facts
| Lead sponsor | TRB Chemedica AG |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 1 January 2007 |
| Primary completion | 1 August 2009 |
| Estimated completion | 1 August 2009 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Ostenil
- Standard arthroscopic procedure
Conditions studied
- Arthroscopic Surgery — all drugs for Arthroscopic Surgery →
Sponsor
TRB Chemedica AG
Who can join
Adults 18 to 80, any sex, with Arthroscopic Surgery. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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 maxim
Sponsor's own description
The primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01254682
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other TRB Chemedica AG trials
Trials by the same sponsor.
- NCT04757051 — Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis · completed
- NCT03879434 — Routine Application of Ostenil® Mini in Patients with Rhizarthrosis · completed
- NCT03809962 — Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis · completed
- NCT03734315 — Routine Application of Ostenil® in Patients with Gonarthrosis · completed
- NCT03494140 — Viscontour® Serum Med in Hydration of Facial Skin · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01254682 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by TRB Chemedica AG
- Last refreshed: 27 September 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01254682.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing