Partial Thickness Supraspinatus Tendon TearNCT02200939

Post-Market Evaluation of the Rotation Medical Rotator Cuff System

A study testing Bioinductive implant and Surgical repair in people with Partial Thickness Supraspinatus Tendon Tear and Full Thickness Supraspinatus Tendon Tear, run by Smith & Nephew, Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the treatment of supraspinatus tendon tears. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Partial Thickness Supraspinatus Tendon Tear, Full Thickness Supraspinatus Tendon Tear
What is being tested?: Bioinductive implant and Surgical repair
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 148 participants
Where: 15 sitesUnited States
Study dates: 20 Aug 2014to 24 Nov 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects enrolled in the study MUST meet all of the following criteria:
At least 21 years of age
Rotator cuff tear requiring surgery that meets either criterion A or B:
Medium or large partial-thickness tear or very small full-thickness tear of the supraspinatus tendon planned for standalone treatment (no surgical repair with sutures/suture anchors) with the bioinductive implant B. Medium or large full-thickness tear primarily of the supraspinatus tendon planned for treatment with the bioinductive implant adjunctive to surgical repair
Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections
MRI of the shoulder within 60 days prior to the study procedure

Show all 10Show fewer

Willing to comply with the prescribed post-operative rehabilitation program
Willing to be available for each protocol-required follow-up examination
Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures
Ability to read, understand, and complete subject-reported outcomes in English

Who cannot join

Subjects enrolled in the study MUST NOT meet any of the following criteria:
Massive rotator cuff tears (≥ 5 cm)
Acute rotator cuff tears less than 12 months from injury
Previous rotator cuff surgery on the index shoulder
Instability of the index shoulder
Chondromalacia of index shoulder ≥ Grade 3

Show all 20Show fewer

Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2
Calcification of the index shoulder rotator cuff
Genetic collagen disease
History of insulin dependent diabetes
History of auto-immune or immunodeficiency disorders
History of chronic inflammatory disorders
Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
History of heavy smoking (> 1 pack per day) within last 6 months
Hypersensitivity to bovine-derived materials
Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder
Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
History of cognitive or mental health status that interferes with study participation

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Texas Orthopedic Specialists, P.L.L.C.
Bedford, Texas, 76021
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Cleveland Clinic
Cleveland, Ohio, 44125
Steadman Hawkins Clinic-Denver
Denver, Colorado, 80111
Twin Cities Orthopedics
Edina, Minnesota, 55435
Holy Cross Hospital Orthopedic Research Institute
Fort Lauderdale, Florida, 33334
Bone & Joint Clinic of Houston
Houston, Texas, 77030
University of Iowa Sports Medicine
Iowa City, Iowa, 52242
ProOrtho Orthopedic Clinic
Kirkland, Washington, 98034
Princeton Orthopaedic Associates, P.A.
Princeton, New Jersey, 08540
OrthoIllinois, LTD
Rockford, Illinois, 61107
Harbin Clinic Orthopaedics & Sports Medicine Rome
Rome, Georgia, 30165
Towson Orthopaedic Associates / University of Maryland St Joseph Med Ctr
Towson, Maryland, 21204
Great Lakes Orthopaedic Center
Traverse City, Michigan, 49684
Southern California Orthopedic Institute
Van Nuys, California, 91405

Other trials in United States

About this study

Conditions: Partial Thickness Supraspinatus Tendon Tear, Full Thickness Supraspinatus Tendon Tear
Being tested: Bioinductive implant, Surgical repair

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bioinductive implantDevice
Also called Rotation Medical Rotator Cuff System™, REGENETEN™ Bioinductive Implant System.
Surgical repairDevice
Surgical repair with commercially-available sutures/suture anchors.

Study groups in NCT02200939
Study group	Role	What they receive
Partial-Thickness Tear	Experimental	Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear of the supraspinatus tendon surgically treated by implantation of the bioinductive implant. Receives: Device: Bioinductive implant
Full Thickness Tear	Experimental	Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair. Receives: Device: Bioinductive implant; Device: Surgical repair

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Tendon Thickness
The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).
Measured: Pre-operatively (baseline) to 3 month, 1 year, and 2 year
Integration of Induced Tissue With Underlying Tendon
Partial-thickness tears were classified as Intermediate (3-6 mm) or High (> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions:
1. Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?
2. Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?
3. Was there evidence of bursitis in the shoulder?
4. Does the new tissue resemble normal tendon tissue?
5. Does the underlying tendon resemble normal tendon tissue?
6. Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?
Measured: 3 months, 1 year, and 2 years
Fill-In of Partial Thickness Tears and Underlying Tendon Quality
For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as:
- 0 to <25%
- 25% to <50%
- 50% to < 75%
- 75% to < 100%
- 100%
Measured: 3 months, 1 year, and 2 years
Number of Participants With a Re-Tear
Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.
Measured: 3 months, 1 year, and 2 years

Secondary outcomes (9)

Procedure Parameters: Device Implant Time
Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.
Measured: Intraoperative
Procedure Parameters: Procedure Technical Success
Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).
Measured: Intraoperative
American Shoulder and Elbow Society (ASES) Score
The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows:
1. ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better).
2. ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better).
3. ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better).
Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).
Measured: Baseline, 3 month, 1 year, and 2 years
Constant-Murley Shoulder (CMS) Score
The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).
Measured: Baseline, 3 months, 1 year, and 2 years
Recovery: Sling Time
Cumulative number of days index shoulder was in a sling.
Measured: Post-operatively to study completion, approximately 2 years
Recovery: Rehabilitation Time
Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.
Measured: Post-operatively to study completion, approximately 2 years
Recovery: Return to Work
Cumulative number of days between discharge and return to work (employed subjects only).
Measured: Post-operatively to study completion, approximately 2 years
Recovery: Return to Normal Daily Activities
Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.
Measured: Post-operatively to study completion, approximately 2 years
Participant Satisfaction
Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following:
- Strongly Disagree
- Disagree
- Neither Agree or Disagree
- Agree
- Strongly Agree
"Strongly Disagree" indicated the lowest level of satisfaction and "Strongly Agree" indicated the greatest level of satisfaction.
Measured: 3 months, 1 year, and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 201424 Nov 2020

First posted25 Jul 2014 (estimated)
Study start20 Aug 2014
Primary completion24 Nov 2020
Study completion24 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Partial Thickness Supraspinatus Tendon TearStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02200939
Sponsor's protocol ID: 2014.05.12
Status last verified: Feb 2022
First submitted: 23 Jul 2014
Last updated: 2 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Market Evaluation of the Rotation Medical Rotator Cuff System
ClinicalTrials.gov ID: NCT02200939
Acronym / sponsor ID: 2014.05.12
Conditions: Partial Thickness Supraspinatus Tendon Tear, Full Thickness Supraspinatus Tendon Tear
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 20 Aug 2014 (actual)
Primary completion: 24 Nov 2020 (actual)
Study completion: 24 Nov 2020 (actual)
First posted: 25 Jul 2014 (estimated)
Results: Posted 2 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Partial-Thickness Tear	Experimental	Device: Bioinductive implantIntermediate or High partial-thickness tear (PTT) or very small full-thickness tear of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Full Thickness Tear	Experimental	Device: Bioinductive implant, Device: Surgical repairMedium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

At least 21 years of age
Rotator cuff tear requiring surgery that meets either criterion A or B:
Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections
MRI of the shoulder within 60 days prior to the study procedure
Willing to comply with the prescribed post-operative rehabilitation program

Key exclusion criteria (20 listed)

Massive rotator cuff tears (≥ 5 cm)
Acute rotator cuff tears less than 12 months from injury
Previous rotator cuff surgery on the index shoulder
Instability of the index shoulder
Chondromalacia of index shoulder ≥ Grade 3

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bioinductive implantAlso: Rotation Medical Rotator Cuff System™, REGENETEN™ Bioinductive Implant System.	Device	Full Thickness Tear, Partial-Thickness Tear
Surgical repairSurgical repair with commercially-available sutures/suture anchors.	Device	Full Thickness Tear

Primary outcome

Change in Tendon Thickness
Time frame: Pre-operatively (baseline) to 3 month, 1 year, and 2 year
The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).
Integration of Induced Tissue With Underlying Tendon
Time frame: 3 months, 1 year, and 2 years
Partial-thickness tears were classified as Intermediate (3-6 mm) or High (> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions: 1. Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? 2. Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? 3. Was there evidence of bursitis in the shoulder? 4. Does the new tissue resemble normal tendon tissue? 5. Does the underlying tendon resemble normal tendon tissue? 6. Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?
Fill-In of Partial Thickness Tears and Underlying Tendon Quality
Time frame: 3 months, 1 year, and 2 years
For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as: * 0 to <25% * 25% to <50% * 50% to < 75% * 75% to < 100% * 100%
Number of Participants With a Re-Tear
Time frame: 3 months, 1 year, and 2 years
Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.

9 secondary outcomes

Procedure Parameters: Device Implant Time
Time frame: Intraoperative
Procedure Parameters: Procedure Technical Success
Time frame: Intraoperative
American Shoulder and Elbow Society (ASES) Score
Time frame: Baseline, 3 month, 1 year, and 2 years
Constant-Murley Shoulder (CMS) Score
Time frame: Baseline, 3 months, 1 year, and 2 years
Recovery: Sling Time
Time frame: Post-operatively to study completion, approximately 2 years
Recovery: Rehabilitation Time
Time frame: Post-operatively to study completion, approximately 2 years
Recovery: Return to Work
Time frame: Post-operatively to study completion, approximately 2 years
Recovery: Return to Normal Daily Activities
Time frame: Post-operatively to study completion, approximately 2 years
Participant Satisfaction
Time frame: 3 months, 1 year, and 2 years

Results and safety

Results posted to the registry on 2 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Partial-Thickness Tear	33	31
Full Thickness Tear	115	104

Primary outcome: Change in Tendon Thickness

Time frame: Pre-operatively (baseline) to 3 month, 1 year, and 2 year. Mean (Standard Deviation). Unit: millimeters

Measure	Intermediate Partial-Thickness Tear n = 12	High Partial-Thickness Tear n = 21	Medium Full Thickness Tear n = 58	Large Full Thickness Tear n = 38
Change from Baseline to 3 Month	1.7 (1.5)	2.6 (19)	1.2 (1.7)	1.2 (2.2)
Change from Baseline to 1 Year	1.4 (1.3)	2.3 (1.8)	0.6 (1.9)	0.7 (2.2)
Change from Baseline to 2 Year	1.2 (1.3)	1.8 (2.2)	0.7 (2.0)	0.7 (2.3)
Change from 3 Months to 1 Year	-0.3 (0.4)	-0.4 (0.6)	-0.5 (1.3)	-0.4 (1.9)
Change from 3 Months to 2 Year	-0.3 (0.4)	-0.8 (1.2)	-0.6 (1.6)	-0.6 (1.8)
Change from 1 Year to 2 Year	-0.1 (0.3)	-0.4 (0.9)	-0.2 (0.9)	-0.1 (1.1)

Population analysed: Participants with partial-thickness or full thickness tears that provided data at the specified time frames.

Primary outcome: Integration of Induced Tissue With Underlying Tendon

Time frame: 3 months, 1 year, and 2 years. Count of participants. Unit: Participants

Measure	Intermediate Partial-Thickness Tear n = 12	High Partial-Thickness Tear n = 21	Medium Full Thickness Tear n = 66	Large Full Thickness Tear n = 48
3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?: Yes	2	0	8	2
3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?: No	7	18	14	7
3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?: Unable to determine	3	3	43	38
1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?: Yes	0	0	0	0
1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?: No	5	11	5	5
1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?: Unable to determine	7	9	60	43
2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?: Yes	0	0	0	0
2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?: No	2	7	2	2

Population analysed: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

Primary outcome: Fill-In of Partial Thickness Tears and Underlying Tendon Quality

Time frame: 3 months, 1 year, and 2 years. Count of participants. Unit: Participants

Measure	Intermediate Partial-Thickness Tear n = 12	High Partial-Thickness Tear n = 20
3 Months: 0 to < 25%	1	0
3 Months: 25% to < 50%	0	2
3 Months: 50% to < 75%	1	3
3 Months: 75% to < 100%	8	11
3 Months: 100%	2	4
1 Year: 0 to < 25%	0	1
1 Year: 25% to < 50%	1	0
1 Year: 50% to < 75%	2	3

Population analysed: Only participants with partial-thickness tears that provided data for the specified time frame. Participants with Full Thickness Tears were not assessed as data for this outcome measure can only be obtained from participants with a Partial-Thickness Tear (i.e., participants with full thickness tears cannot provide fill-in partial thickness tear information needed for this outcome).

Primary outcome: Number of Participants With a Re-Tear

Time frame: 3 months, 1 year, and 2 years. Count of participants. Unit: Participants

Measure	High Partial-Thickness Tear n = 21	Medium Full Thickness Tear n = 66	Large Full Thickness Tear n = 49
3 Months	1	3	10
1 Year	1	7	12
2 Years	1	7	14

Population analysed: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Partial-Thickness Tear	1 of 33 (3%)	7 of 33 (21.2%)	0 of 33
Full Thickness Tear	12 of 115 (10.4%)	10 of 115 (8.7%)	0 of 115

Limitations and caveats (from the sponsor): Limitations of the study include minimal source data verification, limited safety event collection due to protocol definition, the independent Sponsor safety review occurred after data was locked and extracted from the database due to acquisition integration process.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura England study chair

Smith & Nephew, Inc.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tendon Thickness (time frame: Pre-operatively (baseline) to 3 month, 1 year, and 2 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02200939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.