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LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair
Phase 4 trial testing ArthroFLEX ECM scaffold graft in Rotator Cuff Tear in 9 participants. Terminated before completion.
| Lead sponsor | Gregory Gilot |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 1 July 2018 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across United States |
Gregory Gilot — full company profile →
18 and older, any sex, with Rotator Cuff Tear. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Success as defined by tendon healing after rotator cuff repair, as indicated based on MRI
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 0 | |
| Treatment Group | 3 | |
| Alternative Treatment Group | 1 |
Comparison of tendon healing will be assessed using US imaging modalities versus MRI (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 0 | |
| Treatment Group | 3 | |
| Alternative Treatment Group | 1 |
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 3 | |
| Treatment Group | 3 | |
| Alternative Treatment Group | 1 |
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 1 | |
| Treatment Group | 3 | |
| Alternative Treatment Group | 1 |
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 3 | |
| Treatment Group | 3 | |
| Alternative Treatment Group | 1 |
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 0 | |
| Treatment Group | 3 | |
| Alternative Treatment Group | 1 |
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 50.75 | ± 20.15 |
| Treatment Group | 37.66 | ± 15.69 |
| Alternative Treatment Group | 52.00 |
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 58.25 | ± 20.20 |
| Treatment Group | 58.66 | ± 21.00 |
| Alternative Treatment Group | 45.00 |
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 66.66 | ± 21.38 |
| Treatment Group | 74.00 | ± 19.05 |
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 73.00 | ± 26.51 |
| Treatment Group | 77.00 | ± 16.52 |
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 82.75 | ± 21.96 |
| Treatment Group | 77.66 | ± 7.50 |
| Alternative Treatment Group | 60.00 |
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
| Group | Value | 95% CI |
|---|---|---|
| Control Treatment Group | 85.00 | ± 15.03 |
| Treatment Group | 88.00 | ± 6.55 |
| Alternative Treatment Group | 55.00 |
Time frame: Within 1 year after surgery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Control Treatment Group | Treatment Group | Alternative Treatment Group |
|---|---|---|---|---|
| Dry eyes | Eye disorders | — | — | — |
| Posterior vitrous detachment | Eye disorders | — | — | — |
| Pain from shoulder to hand | Musculoskeletal and connective tissue disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Low back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Atypical chest pain | Cardiac disorders | — | — | — |
| Back muscle spasm | Musculoskeletal and connective tissue disorders | — | — | — |
| Foot pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Hip contusion | Injury, poisoning and procedural complications | — | — | — |
| Shoulder tear (contralateral) | Musculoskeletal and connective tissue disorders | — | — | — |
| Covid-19 positive | Infections and infestations | — | — | — |
Data from ClinicalTrials.gov NCT03551509 adverse events section.
This trial is to evaluate the effectiveness of the ArthroFLEX® ECM scaffold graph as an augment in rotator cuff repair surgery to reduce the failure rate of rotator cuff repairs for large and massive rotator cuff tears.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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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/NCT03551509.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing