NCT04580290 is a clinical trial of JewelACL in Anterior Cruciate Ligament Injuries, sponsored by Xiros Ltd.

Who is sponsoring NCT04580290?

NCT04580290 is sponsored by Xiros Ltd.

What drugs are being tested in NCT04580290?

Interventions in NCT04580290: JewelACL.

What condition does NCT04580290 study?

NCT04580290 studies Anterior Cruciate Ligament Injuries.

Is NCT04580290 still recruiting?

NCT04580290 is currently completed. Last updated 2 November 2021.

Are results published for NCT04580290?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-11-02 · How we verify

NCT04580290

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Jewel ACL Post Market Clinical Follow Up Study

Completed Results posted Last updated 2 November 2021

What this trial tests

trial testing JewelACL in Anterior Cruciate Ligament Injuries in 120 participants. Completed in 9 April 2021.

Timeline

2 October 2020

Primary endpoint
9 April 2021

9 April 2021

Quick facts

Lead sponsor	Xiros Ltd
Status	Completed
Study type	OBSERVATIONAL
Enrollment	120
Start date	2 October 2020
Primary completion	9 April 2021
Estimated completion	9 April 2021
Sites	1 location across Poland

Drugs / interventions tested

JewelACL

Conditions studied

Anterior Cruciate Ligament Injuries — all drugs for Anterior Cruciate Ligament Injuries →

Sponsor

Xiros Ltd

Who can join

18 and older, any sex, with Anterior Cruciate Ligament Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Occurrence of Re-ruptures Primary · Five Year

Number of participants with re-rupture that were implanted with the jewelACL device for ACL reconstruction

Group	Value	95% CI
JewelACL Only	5
JewelACL + Autograft (Hybrid)	1

Adverse events — posted to ClinicalTrials.gov

Time frame: From time of surgery to the minimum follow up period (5 years post surgery). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

JewelACL Only

Serious: 5/88 (6%)

Deaths: 0/88

JewelACL + Autograft (Hybrid)

Serious: 1/32 (3%)

Deaths: 0/32

Serious adverse events (1 terms)

Reaction	System	JewelACL Only	JewelACL + Autograft (Hybr…
Rupture	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	JewelACL Only	JewelACL + Autograft (Hybr…
Infection	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Rupture.

Data from ClinicalTrials.gov NCT04580290 adverse events section.

Sponsor's own description

The objective of the study is to assess re-rupture rates and patient outcomes from subjects with at least 5 year follow up, treated with the JewelACL device for ACL reconstruction. The impact of fixation type and autograft augmentation will also be assessed. All adverse events related to the JewelACL device will be recorded. This study is Sponsored by Xiros.

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:

Other recruiting trials for Anterior Cruciate Ligament Injuries

Currently open trials in the same condition.

NCT07501013 — Clinical Outcomes of Arthroscopic Surgeries for Shoulder and Knee Sports Injuries · recruiting
NCT07333092 — Investigation of the Effects of Proprioceptive Exercises After Anterior Cruciate Ligament Surgery · NA · recruiting
NCT07346326 — Comparative Study of Functional Outcomes Between Peroneus Longus and Hamstring Tendon Autografts in Arthroscopic ACL Rec · NA · recruiting
NCT07306221 — Effect of Visual-Guided Balance Training on Knee Motor Function and Biomechanical Characteristics After ACL Reconstructi · NA · recruiting
NCT07486466 — ACL Mechanical Property Changes in Female Collegiate Basketball Players During a Competitive Season · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04580290 (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 Xiros Ltd
Last refreshed: 2 November 2021

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/NCT04580290.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing