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).
How to x-ray the shoulder (see this link).
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).

Rotator cuff repair - is a porcine dermal patch of value to the patient?

Prospective randomized controlled trial for patch augmentation in rotator cuff repair: 24-month outcomes

These authors used a double-blinded randomized control trial of 92 patients to evaluate the anatomic integrity of rotator cuff repair performed by medialized single row and augmented by a porcine dermal patch, in comparison with a nonaugmented group.

The patch group showed a healing by MRI of 97.6% compared with 59.5% for the standard repair group. 

However, there was no significant difference for most of the outcome measures of patient comfort and function.

Comment:

It is of note that the patient reported outcomes by Simple Shoulder Test were outstanding for both the non-patch and the patch groups: preoperative scores of 3 to postoperative scores of 10, representing an improvement of over 80% of the maximum possible improvement.

This article did not compare the MRI results with the clinical results - this would seem to be important for determining the clinical importance of the MRI outcomes.

The article did not report on the incremental operative time or cost attributable to the use of the porcine graft.

At this point, therefore the value to the patient of the porcine graft remains undetermined.

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We have a new set of shoulder youtubes about the shoulder, check them out at this link.

Be sure to visit "Ream and Run - the state of the art"  regarding this radically conservative approach to shoulder arthritis at this link and this link

Use the "Search" box to the right to find other topics of interest to you.

How you can support progress in shoulder surgery

You may be interested in some of our most visited web pages   arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

Rotator cuff tears - are fascia lata grafts of value?

Bone healing potential of fascia lata autografts to the humeral head footprint in rotator cuff reconstruction based on magnetic resonance imaging and histologic evaluations

These authors sought to evaluate the bone healing potential of fascia lata autograft (FLA) by magnetic resonance imaging (MRI) 69 patients at > 6 months ( mean of 35.6 months,  range 10-78 months)) after surgery.

Based on MRI, retear cases were divided into type 1 (the graft did not remain on the greater tuberosity) and type 2 (the graft remained on the greater tuberosity).

Only 50% of the grafts were intact at followup: there were 35 intact repairs and 34 failures: 7 type 1 and 27 type 2 shoulders.

Comment: This study did not provide clinical evaluation of these 69 patients so we do not know if this procedure was of value to the patients or if healing of the graft affected the outcome. The added cost and complications of the use of a fascial graft are not mentioned. Harvest of fascia late is a morbid procedure and needs justification based on clinical benefit to the patient.

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We have a new set of shoulder youtubes about the shoulder, check them out at this link.

Be sure to visit "Ream and Run - the state of the art" regarding this radically conservative approach to shoulder arthritis at this link and this link

Use the "Search" box to the right to find other topics of interest to you.

How you can support progress in shoulder surgery

You may be interested in some of our most visited web pages  arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

Treatment of large rotator cuff tears with a graft - the problem with long-term followup

Long-term clinical and radiographic outcome of rotator cuff repair with a synthetic interposition graft: a consecutive case series with 17 to 20 years of follow-up

These authors sought the long term outcomes of treatment for 13 irreparable cuff tears using synthetic interposition grafts made of Dacron to bridge the defect between the residual tendon and the tuberosity. The patients included 11 men and 2 women with a mean age of 55 years (range, 38-72 years).

After a mean of 18 years (range, 17-20 years), 1 patient had died, and 12 were available for x-ray imaging and 10 also for ultrasonography and clinical scores. Cuff tear arthropathy (Hamada grade ≥2) had developed in 9 of 12 (75%; 95% confidence interval, 43%-95%), including 3 patients operated on with arthroplasty in the follow-up period. 

The mean absolute Constant-Murley score was 46 (standard deviation, 26), and the mean Western Ontario Rotator Cuff score was 59 (standard deviation, 20). In 7 of 10 patients (70%) with available ultrasonography, the graft was interpreted as not intact. 

All patients had a contralateral full-thickness tear, and 7 of 12 patients (58 %; 95% confidence interval, 28%-85%) had contralateral cuff tear arthropathy. The number of patients with cuff tear arthropathy was not significantly different between the shoulder repaired with a Dacron graft and the contralateral shoulder (P = .667). 

Comment: Here we have a common issue in clinical research. Patients want to know the long term results of the treatment they are considering. But usually we can only give them either (1) the long term results of a method no longer in use (such as a Dacron graft)

or (2) the short term results of a new type of graft

as shown in a recent post (see this link)

or even a balloon

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We have a new set of shoulder youtubes about the shoulder, check them out at this link.

Be sure to visit "Ream and Run - the state of the art" regarding this radically conservative approach to shoulder arthritis at this link and this link

Use the "Search" box to the right to find other topics of interest to you.

How you can support progress in shoulder surgery

You may be interested in some of our most visited web pages arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

Is PRP of value in rotator cuff repair?

Platelet-rich plasma in fibrin matrix to augment rotator cuff repair: a prospective, single-blinded, randomized study with 2-year follow-up

These authors performed a prospective, randomized, single-blinded study of 76 patients divided into 2 randomized groups, a treatment group having arthroscopic rotator cuff repair with Platelet-rich plasma in fibrin matrix (RPFM).

The control group did not receive the PRPFM.

The Simple Shoulder improved from 45% to 96% in the control group and from 49% to 96% in the PRPFM group.

Strength of the supraspinatus at 24 months by dynamometer testing was 99.8% in the control group and 96.3% in the PRPFM group. 

Retears by MRI at 6 months occurred at a rate of 19% for the controls and 7.4% for the PRPFM technique at 6 months. 

None of these results showed a statistically significant benefit of PRPFM.

Comment: The cost of the PRPFM is not presented in this paper.

It would be of interest for the authors to do a sample size calculation to determine how many subjects would be necessary to detect a possible significant difference in retear rate.

It would also be of interest to compare the SST scores of the shoulders with and without retears.


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Use the "Search" box to the right to find other topics of interest to you.

How you can support progress in shoulder surgery

You may be interested in some of our most visited web pages   arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

Rotator cuff repair, does integrity matter?

A prospective, multicenter study to evaluate clinical and radiographic outcomes in primary rotator cuff repair reinforced with a xenograft dermal matrix.

These authors point to the prevalence of retears after cuff repair: "Galatz et al reviewed 18 patients after arthroscopic repair of tears > 2 cm using a single-row technique and ultrasound evaluation after 12 months and found 17 of 18 retears. Lee et al reported retear after arthroscopic double-row repair in 30 of 62 (48.4%). In patients aged > 60 years, the retear rate was 62.5%, and medium to large tears retore in 27 of 51 (53%). Tashjian et al reported arthroscopic repair of 2-tendon tears evaluated by ultrasound imaging and found 64% retears after double-row repair. Bishop et al evaluated open and arthroscopic rotator cuff repair by MRI. Large rotator cuff tears had a retear rate of 38% in the open group and 76% in the arthroscopic group."

Against this background they conducted a study of 61 shoulders with large rotator cuff tears (3 to 5 cm) surgically repaired and reinforced with a extracellular matrix (ECM) graft.  The average tear size was 3.8 cm.

Three patients underwent surgical revision. Complications included 1 deep infection.

Functional outcome scores, isometric muscle strength, and active range of motion were significantly improved compared with baseline. Magnetic resonance imaging at 12 months showed retorn rotator cuff repairs in 33.9% of shoulders, using the criteria of a tear of at least 1 cm.

Comment: This is a carefully done followup study but does not offer the opportunity to compare outcomes of repairs with and without application of the ECM.

It is of interest that the functional outcomes were not different for shoulders with and without retears, as shown below.

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Use the "Search" box to the right to find other topics of interest to you.

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Irreparable cuff tears - is an iliotibial-bone autograft useful?

Rotator cuff repair using an original iliotibial ligament with a bone block patch: preliminary results with a 24-month follow-up period.

These authors advocate managing massive shoulder rotator cuff tears not amenable to primary repair with a patching method that uses an autograft consisting of a section of the iliotibial band with an attached bone block so that the ligament part of the graft is sutured to the remaining rotator cuff and the bone end fixed to the greater tuberosity using a suture bridge. They state that this operative procedure is applicable when primary repair is not possible but repair of the subscapularis and infraspinatus muscles alone is possible

They report 5 patients with 2 years followup.

Patients were clinically improved. No mention is made of complications or the time necessary to perform the procedure.  Fusion of the bone graft with the greater tubercle of the humerus was confirmed on computed tomography in all patients. No retearing was observed on magnetic resonance imaging at the 24-month point, and the thickness of the ligament part of the graft was maintained.

Comment: This is clearly a big procedure, requiring surgery on the shoulder and the knee.

Below is a preoperative MRI

And here is a postoperative MRI at two years. While tissue apparently remains between the humeral head and the acromion, the muscle seems to have remained atrophic and the connection between the graft and the muscle appears slack.

it will be important to compare the results of this procedure with a more conservative surgical procedure in which no attempt is made to span the defect in the rotator cuff, the smooth and move. See this link 

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Check out the new Shoulder Arthritis Book - click here.

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Use the "Search" box to the right to find other topics of interest to you.

You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

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Arthroscopic patch autograft procedure for large to massive rotator cuff tears - are we asking the right question?

Effect of Fatty degeneration of the infraspinatus on the efficacy of arthroscopic patch autograft procedure for large to massive rotator cuff tears.

These authors investigated the results of an arthroscopic fascia lata autograft patch procedure in 45 patients with large to massive rotator cuff tears with high-grade fatty degeneration of the supraspinatus and either low-grade (group L; n=26) or high-grade (group H; n=19) fatty degeneration of the infraspinatus.

Patients in group L had a lower rate of failed repairs (27%) than did those in group H (89%)  as assessed by MRI. The clinical outcome scores and muscle strength ratios were significantly higher in group L than in group H. 

Comment: It is not surprising that patients with more severe cuff disease (high-grade fatty degeneration of both the supraspinatus and the infraspinatus) did more poorly than those with less severe disease (high-grade fatty degeneration of the supraspinatus and low grade fatty degeneration of the infraspinatus). The rate of failure of the repair attempt was high in both groups - even in the 'low grade' group, more than one out of four repairs failed.

The question we should be asking is "what is the value of the arthroscopic patch"? In other words is the improvement in the anatomic and clinical outcomes with this repair technique sufficient to offset the incremental cost and risk of this procedure in comparison to simpler strategies? 

Should we be trying to repair the irreparable?

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Rotator cuff repair - are graft patches of value to the patient?

Treatment of massive and recurrent rotator cuff tears augmented with a poly-l-lactide graft, a preliminary study.

These authors reported on 16 patients with repair of  two tendon tears augmented with a  poly-l-lactide synthetic polymer. Two patients required the patch to bridge defects, and 1 patient retore after a motor vehicle accident and had revision surgery at another institution. The 13 remaining patients were retrospectively evaluated from 1.2 to 1.7 years (average, 1.5 years) after surgery.  Five patients (38%) had an intact rotator cuff according to MRI at the time of follow-up. The remaining patients (62%) had full-thickness tears. 

The authors do not indicate that the clinical results correlated with the integrity of the repair.

A prior related post can be found here.

Comment:

The authors do not present data on the incremental cost of this device - either in terms of the cost of the device itself or the time necessary to implant it. Many previous reports of cuff repair have presented improvements in clinical measures even though the surgery failed to achieve integrity of the rotator cuff repair. This study does not demonstrate that this graft has value to the patient.

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Cuff repairs and patch reinforcement

Long-term successful arthroscopic repair of large and massive rotator cuff tears with a functional and degradable reinforcement device.

This author reports a small series of 18 patients with repairs of large to massive rotator cuff tears reinforced with a poly-l-lactic acid synthetic patch.

The ultrasound examination targeted the supraspinatus, infraspinatus, and subscapularis to detect the presence of the tendons and their attachment to the bone. The shoulder was observed while the patient moved the arm to determine attachment and functionality of the graft. This examination showed that 15 of 18 patients had intact rotator cuff repair at 12 months; at 42 months, an additional patient had a failed repair. 

Overall, patients showed improvement in the ASES shoulder score from 25 preoperatively to 70 at 42 months after surgery. Patients with intact rotator cuff (n = 14) at 42 months had an ASES shoulder score of 82.

Comment: While these results seem encouraging, the experience of the sonographer and the ability of the technique to determine the integrity of a repair after grafting is not stated. 

At this time the reported results with patch reinforcement are not universally favorable as shown here, and here, and here. At present we have not found the evidence supporting the use of patches in cuff repair to be compelling.

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What is the value of patch augmentation in the treatment of massive rotator cuff tears?

Treatment of massive and recurrent rotator cuff tears augmented with a poly-l-lactide graft, a preliminary study.

These authors report a retrospective study of 16 patients with massive or recurrent rotator cuff tears who underwent open repair with synthetic poly-l-lactide patch augmentation. Three patients were excluded: two required the patch to bridge defects, and one retore after a motor vehicle accident and had revision surgery at another institution.

The followup for the 13 remaining patients was 1.2 to 1.7 years (average, 1.5 years). Magnetic resonance imaging was used to examine the integrity of the repair at a minimum of 1 year of follow-up.

Five patients (38%) had an intact rotator cuff at the time of follow-up. The remaining patients (62%) had full-thickness retears. The PENN and American Shoulder and Elbow Surgeons scores significantly improved. Data were not provided on the results in those with retears in comparison to those with intact repairs. 

Comment: From the data presented it is difficult to determine the value of the graft, that is the improvement in the outcome divided by the cost of the device and the additional time to implant it. The role of the graft in determining the result for these patients is unknown.

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To see the topics covered in this Blog, click here

Use the "Search" box to the right to find other topics of interest to you.

You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

A 'new' patch for rotator cuff repairs. Is this BBC news?

Researchers in Oxford have developed a degradable implant which they say has huge potential to improve surgical success rates

This article by the BBC talks of the promise of a "protective patch, which wraps round soft tissue repairs" that will be trialled in patients with shoulder injuries.

The article reports that 10,000 shoulder repair operations are carried out each year in England and Wales and that figure has risen by 500% in the last decade. "But one in four procedures is not successful, because the tendon tears again."

This report is based on laboratory tests that have been encouraging, but clinical trials have yet to begin. The team claims, "We've used modern technology to produce very fine fibres which have the extraordinary ability to direct the way cells behave, and "wake up" tired and aging cells, and make them want to heal, whereas previously they weren't being made to want to heal. The material in the patch is degradable, and disappears after a few months."

While we're all for research in improving the currently suboptimal anatomical and clinical results of cuff repair, it seems a bit early to for the BBC to be proclaiming the promise of the 'degradable implant'. Here are some previous posts on attempts to improve the biology of tendon healing in cuff repair.

Patch

Patch

Platelet-leukocyte membrane
Platelet fibrin matrix
Platelet rich plasma

It has been proposed that Graft Jacket may be useful in this regard, but results of a clinical trial have yet to be reported. The trial started in 2007 and was to be completed in 2010. We'd be most interested if any of the readers know of a results report.

A terrific review of 'patches' is provided here from the Wrightington Upper Limb Unit - a must read!

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Consultation for those who live a distance away from Seattle.

**Check out the new Shoulder Arthritis Book - click here.**

Click here to see the new Rotator Cuff Book

To see the topics covered in this Blog, click here

Use the "Search" box to the right to find other topics of interest to you.

You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

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