Trial Outcomes & Findings for Jewel ACL Post Market Clinical Follow Up Study (NCT NCT04580290)

NCT ID: NCT04580290

Last Updated: 2021-11-02

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 120 participants
• Primary outcome timeframe: Five Year
• Results posted on: 2021-11-02

Participant Flow

Participant milestones

Measure	JewelACL Only Patients who received JewelACL only	JewelACL + Autograft (Hybrid) Patients who received a JewelACL and autograft
Overall Study STARTED	88	32
Overall Study COMPLETED	88	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Jewel ACL Only n=88 Participants Subjects who received only the JewelACL	JewelACL + Autograft (Hybrid) n=32 Participants Subjects who received the JewelACL + Autograft (hybrid)	Total n=120 Participants Total of all reporting groups
Age, Continuous	32.3 years STANDARD_DEVIATION 10.1 • n=88 Participants	32.2 years STANDARD_DEVIATION 11.4 • n=32 Participants	32.3 years STANDARD_DEVIATION 10.4 • n=120 Participants
Sex: Female, Male Female	17 Participants n=88 Participants	5 Participants n=32 Participants	22 Participants n=120 Participants
Sex: Female, Male Male	71 Participants n=88 Participants	27 Participants n=32 Participants	98 Participants n=120 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Sports participation-yes	66 Participants n=88 Participants	24 Participants n=32 Participants	90 Participants n=120 Participants
Cause of ACL failure Sports Injury	72 Participants n=88 Participants	23 Participants n=32 Participants	95 Participants n=120 Participants
Cause of ACL failure Traffic Accident	3 Participants n=88 Participants	1 Participants n=32 Participants	4 Participants n=120 Participants
Cause of ACL failure Other Accident	3 Participants n=88 Participants	4 Participants n=32 Participants	7 Participants n=120 Participants
Cause of ACL failure Not available	10 Participants n=88 Participants	4 Participants n=32 Participants	14 Participants n=120 Participants
Femoral Fixation Endobutton TightRope Arthrex	0 Participants n=88 Participants	1 Participants n=32 Participants	1 Participants n=120 Participants
Femoral Fixation Linvatec XO	0 Participants n=88 Participants	1 Participants n=32 Participants	1 Participants n=120 Participants
Femoral Fixation Medgal Screw	86 Participants n=88 Participants	29 Participants n=32 Participants	115 Participants n=120 Participants
Femoral Fixation S+N EndoButton	2 Participants n=88 Participants	1 Participants n=32 Participants	3 Participants n=120 Participants
Tibial Fixation Medgal screw	88 Participants n=88 Participants	32 Participants n=32 Participants	120 Participants n=120 Participants

PRIMARY outcome

Timeframe: Five Year

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

Outcome measures

Measure	JewelACL Only n=88 Participants Patients who received JewelACL only	JewelACL + Autograft (Hybrid) n=32 Participants Patients who received a JewelACL and autograft
Occurrence of Re-ruptures	5 Participants	1 Participants

Adverse Events

JewelACL Only

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

JewelACL + Autograft (Hybrid)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	JewelACL Only n=88 participants at risk Patients who received JewelACL only	JewelACL + Autograft (Hybrid) n=32 participants at risk Patients who received a JewelACL and autograft
Musculoskeletal and connective tissue disorders Rupture	5.7% 5/88 • Number of events 5 • 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	3.1% 1/32 • Number of events 1 • 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

Other adverse events

Measure	JewelACL Only n=88 participants at risk Patients who received JewelACL only	JewelACL + Autograft (Hybrid) n=32 participants at risk Patients who received a JewelACL and autograft
Musculoskeletal and connective tissue disorders Infection	1.1% 1/88 • Number of events 1 • 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	0.00% 0/32 • 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

Additional Information

Tracey Oxley

Xiros Ltd

Phone: 07810337555

Email: Tracey.Oxley@xiros.co.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place