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NCT04592367
Reconstruction of the Anterior Cruciate Ligament(ACL-R) in the 30+-Year Old Assessed by Patient Reported Outcome Measures(PRO) Using the Nationwide Danish Knee Ligament Reconstruction Registry
trial testing Patient age at time of procedure of reconstruction of ACL in Cruciate Ligament Rupture in 30,487 participants. Completed in 31 December 2018.
31 December 2018
Quick facts
| Lead sponsor | Region Zealand |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 30,487 |
| Start date | 1 January 2005 |
| Primary completion | 31 December 2018 |
| Estimated completion | 31 December 2018 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Patient age at time of procedure of reconstruction of ACL
Conditions studied
- Cruciate Ligament Rupture — all drugs for Cruciate Ligament Rupture →
Sponsor
Region Zealand
Who can join
Eligibility, any sex, with Cruciate Ligament Rupture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to evaluate the efficacy of primary ACL-R in patients 30 years of age or older using PRO. The PRO used are Knee Osteoarthritis Outcome Score(KOOS) and Tegner score. The Danish Knee Ligament Reconstruction Registry has data including more than 31,000 primary ACL-R performed in the period from 2005 to 2018, of which approximately a little less than 40% are performed in patients 30 years or older. Traditionally, ACL-R has been used for the active, younger patients with the purpose of returning to their pre-injury level of activity. The increasing activity level and the desire to stay active among some patients in their fourth decade, and later, possibly increases the demands of the reconstructed ACL in this group. The aim is to investigate the PRO in this group of patients and compare them with the PRO of patients younger than 30 years of age. The study may help orthopedic surgeons counselling patients 30 years of age or older when deciding to perform an ACL-R. The study's hypothesis is, that the overall benefit from ACL-R is equal but the patients 30 years of age or older has a worse baseline and as an implication of that worse PRO one year after the ACL-R.
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 NCT04592367
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Related trials
Other recruiting trials for Cruciate Ligament Rupture
Currently open trials in the same condition.
- NCT04184687 — The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction · NA · recruiting
Other Region Zealand trials
Trials by the same sponsor.
- NCT07314450 — Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department · recruiting
- NCT06036043 — Botulinum Toxin for Chronic Neuropathic Pain · unknown
- NCT04370678 — Changes in Preference for Surgery of Patients Signed up for Arthroscopic Procedures · completed
- NCT03999047 — Validation of the Screening Instrument: PRISMA-7 for Frailty Among Elderly Hospitalized Danes · unknown
- NCT04901559 — Subjective Outcomes After ACL Reconstruction With BQT Autograft · 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 NCT04592367 (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 Region Zealand
- Last refreshed: 19 October 2020
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/NCT04592367.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing