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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JewelACL + Autograft (Hybrid) | JewelACL + Autograft (Hybrid) |
| |
| JewelACL only | JewelACL only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JewelACL | Device | The JewelACL is a polyester scaffold for anterior cruciate ligament (ACL) reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Re-ruptures | Number of participants with re-rupture that were implanted with the jewelACL device for ACL reconstruction | Five Year |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients who have had the JewelACL device used to reconstruct the ACL, between the period of 01 October 2010 to 31 December 2014.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Med-Polonia | Poznan | Poland |
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| ID | Title | Description |
|---|---|---|
| FG000 | JewelACL Only | Patients who received JewelACL only |
| FG001 | JewelACL + Autograft (Hybrid) | Patients who received a JewelACL and autograft |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Jewel ACL Only | Subjects who received only the JewelACL |
| BG001 | JewelACL + Autograft (Hybrid) | Subjects who received the JewelACL + Autograft (hybrid) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Re-ruptures | Number of participants with re-rupture that were implanted with the jewelACL device for ACL reconstruction | Posted | Count of Participants | Participants | Five Year |
|
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From time of surgery to the minimum follow up period (5 years post surgery)
AE: Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
SAE: Any AE that led to: death,serious deterioration in the health of the subject, permanent impairment to a body structure or a body function,chronic disease,foetal distress, foetal death or a congenital physical or mental impairment or birth defect
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JewelACL Only | Patients who received JewelACL only | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rupture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Re-Rupture of the ACL |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Decreased ROM identified. Later knee pain, tests results showed infection |
Reruptures can be sustained during sports trauma and cannot necessarily be attributed to device insufficiency.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracey Oxley | Xiros Ltd | 07810337555 | Tracey.Oxley@xiros.co.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2020 | Aug 31, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2021 | Aug 31, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Sports participation-yes | Count of Participants | Participants |
|
| Cause of ACL failure | Count of Participants | Participants |
|
| Femoral Fixation | Count of Participants | Participants |
|
| Tibial Fixation Medgal screw | Count of Participants | Participants |
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| Participants |
|
|
| 88 |
| 5 |
| 88 |
| 1 |
| 88 |
| EG001 | JewelACL + Autograft (Hybrid) | Patients who received a JewelACL and autograft | 0 | 32 | 1 | 32 | 0 | 32 |
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| Other Accident |
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| Not available |
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| Medgal Screw |
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| S+N EndoButton |
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