The value of the Regeneten bioinductive implant in managing rotator cuff disease: what does the literature say?

Recently a patient inquired about the value of Smith+Nephew’s REGENETEN◊ Bioinductive Implant (shown below) in managing her chronic rotator cuff tendinopathy. 

A PubMed search for "Regeneten" in the National Library of Medicine's database of the biomedical literature revealed the following articles:

Seven clinical reports did not compare patient-reported clinical outcomes for cuff repairs with Regeneten to those for cuff repairs without Regeneten.

Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up reported improvement from preoperative clinical scores. There was no control group having similar surgery without the implant.

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears reported improvement from preoperative clinical scores at one year. There was no control group having similar surgery without the implant.

Isolated bioinductive repair of partial-thickness rotator cuff tears using a resorbable bovine collagen implant: two-year radiologic and clinical outcomes from a prospective multicenter study presented 33 patients with partial thickness cuff tears treated with the Regeneten patch. Two year clinical scores were improved from preoperative values. There was no control group having similar surgery without the implant

Tips and Tricks for Augmenting Rotator Cuff Repair With a Bio-inductive Collagen Implant presented a surgical technique for implanting the Regeneten patch. No patient outcome data were presented.

Arthroscopic rotator cuff repair with biologically enhanced patch augmentation presented 22 patients having revision massive rotator cuff repair using the Regeneten patch enhanced with cBMA and PRP. While short term followup (6 months) showed clinical improvement over preoperative scores, there was no control group having similar surgery without the implant

Isolated Bioinductive Arthroscopic Repair of Partial-Thickness Rotator Cuff Tears Using a Resorbable Collagen Implant reported improved 2-year scores in comparison to preoperative scores with this resorbable bovine collagen implant in the treatment of intermediate and high-grade partial-thickness rotator cuff tears. There was no control group having similar surgery without the implant

Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry This registry analysis found improved one year scores after surgery in comparison to preoperative scores  for partial thickness cuff tears with a resorbable bovine collagen implant. There was no control group having similar surgery without the implant

Economic value. Two studies attempted to assess the economic value of Regeneten, but did not evaluate patient reported clinical outcomes.

Resorbable Bioinductive Collagen Implant Is Cost Effective in the Treatment of Rotator Cuff Tears Average cost of treatment $32,213 without Regeneten, $54,459 with Regeneten (additional cost 69%). Did not assess patient reported outcomes or revision rates for patients without or with the patch. While using "healing" as the study endpoint, the authors point out that there is lack of agreement on what constitutes healing or retearing after a cuff repair based on magnetic resonance imaging, ultrasound, or arthrogram. Evidence was not presented that "healing" by imaging correlated with better clinical outcomes .

Economic Evaluation of a Bioinductive Implant for the Repair of Rotator Cuff Tears Compared with Standard Surgery in Italy. Average cost of treatment €4650 without Regeneten, €7828 with Regeneten (additional cost 68%). Study limitations the same as those for the report above.

Complications: The one study that compared clinical outcomes of repairs without and with Regeneten found an eight-fold increase in postoperative stiffness in the Regeneten group. All reoperations were in the Regeneten group.

Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial found that postoperative stiffness was observed in the first 12 weeks in 8 of 32 patients in the patch group compared with 1 of 32 patients in the control group. Six patients in the patch group underwent reoperations compared with no patients in the control group. All 6 reoperations in the patch group were performed to address stiffness. The authors concluded that patients in the patch group had a significantly higher rate of postoperative stiffness. In the majority of patients in whom shoulder stiffness developed, reoperation was required. It seems possible that this stiffness may be related to overstuffing the subacromial space by the graft as well as associated scarring in the humeroscapular motion interface.

A report of revision because of bursitis and rice bodies in a Regeneten-treated cuff repair.

Subacromial-Subdeltoid Bursitis With Rice Bodies After Rotator Cuff Repair With a Collagen Scaffold Implant: A Case Report. reported a case of subacromial-subdeltoid bursitis with rice bodies after rotator cuff repair with a Smith + Nephew REGENETEN bovine-derived bioinductive collagen scaffold implant. After debridement, the patient recovered well and made a full return to work and recreational activities.

Report of revisions because of reactive bursitis.

Revision arthroscopic surgery after rotator cuff repair with a collagen graft: histologic evaluation of biopsy specimens from two patients

Comment: Rotator cuff surgery is the most commonly performed shoulder operation. Thus studies of factors affecting the patient outcomes is of importance both clinically and economically.

It is well recognized that healing of an attempted repair repair can be difficult to assess by postoperative imaging and may not correlate with the functional outcome realized by the patient. 

Well controlled clinical studies are needed to determine whether the substantial increase in cost associated with the Regeneten implant is offset by improved outcomes for the patient.

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Here are some videos that are of shoulder interest
Shoulder arthritis - what you need to know (see this link).
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The ream and run procedure (see this link).
The total shoulder arthroplasty (see this link).
The cuff tear arthropathy arthroplasty (see this link).
The reverse total shoulder arthroplasty (see this link).
The smooth and move procedure for irreparable rotator cuff tears (see this link).
Shoulder rehabilitation exercises (see this link).