The partial-thickness rotator cuff tear debate (in 7 rounds of discussion)

Introduction

750,000 rotator cuff repairs are performed every year in the United States alone…but the expectation is that they increase by around 5% every year.¹ As cases increase, every additional delayed recovery, physical therapy visit or dissatisfied patient adds proportionally to existing challenges.

As forces pull practices in opposing directions - balancing increased cases and patient expectations with a need for efficiency - the need to re-evaluate effective and workable surgical interventions seems, on face value, to be more pressing than ever. The current landscape of partial-thickness tear repair is defined by well-established surgical techniques that have been refined over decades, and while these methods have provided relatively steady outcomes,² they have been associated with drawbacks in terms of recovery times and patient experience.^3,4

Given the current paradigm has honed surgeon training and expertise, and the causes of tears remain unchanged, it could be argued that the only place that change can possiblycome from is in emerging technologies and techniques.

The question is whether existing methods can be refined further to turn the tide of current outcomes, or if a different approach is the only option to deliver improved results sufficiently quickly.

Score: If cases are to increase and outcome challenges persist, the need to at least entertain an alternative seems likely.

Round 2:
What’s the most common approach today?

Several options are available for partial-thickness rotator cuff repair, each with advantages and limitations. To build any rationale – for change or otherwise - starts with an assessment of how options compare.

Non-operative intervention will always be, quite rightly, the first-line treatment. These methods can manage symptoms and improve shoulder function, leading to surgery if pain and limited function persists. The main area of contention is where that non-operative treatment fails, and two frontrunners emerge:

Using takedown and repair

Used in many cases,⁵ the process of detaching torn tendon from the bone, repairing it and reattaching it is truly tried and tested…but there is a trade-off. The pivotal element of removing tendon tissue seems counterproductive from an anatomical and biomechanical perspective…and may account for lengthy post-op recovery.^3,4

Using bioinductive repair

Advances in this area, in the form of the REGENETEN^◊ Bioinductive Implant, represent a promising alternative, treating the tear with a collagen implant to induce the formation of tendon-like tissue.^6-8 By supporting the body's natural healing response,^6-8,10 isolated bioinductive repair was developed to help accelerate^11,12 recovery times and improve post-operative clinical outcomes.^6,7,12-15

As for the outcomes, we need to examine the specific implications in more detail.

Score: Takedown and repair is the more widely used approach, but that does not necessarily mean it’s the most effective in all circumstances.

Round 3:
Rotator cuff biomechanics or biology?

To compare surgical options in more depth, we must examine the two primary considerations of rotator cuff surgery: biomechanics and biology. Traditionally, the focus has been on biomechanical repair; correcting structural damage to restore the shoulder’s mechanical function…but that addresses only half of the equation.

“Biomechanics are all you need”

Biomechanical repairs emphasise structural integrity as the key to restoring shoulder function; underpinned by the belief that strength is what is needed in a repair. Interestingly, in partial-thickness tear repair it often involves the removal of tendon tissue and, consequently, the native anatomy.

If takedown and repair can convert the tear to a more advanced stage before the repair begins, potentially altering the length and tension of the tendon,¹⁶ it seems an immediate compromise.

In what is commonly a chronic condition, tissue quality plays an important role in healing after rotator cuff tear repair. Could it be argued that using techniques that focus solely on biomechanics present a potential challenge in their inability to fully address the underlying biology of the tendon?¹⁷

The fact that biomechanical approaches alone are subject to debate highlights a potential imbalance in the underlying principles of takedown and repair.

“Biology is more important”

Healing is a natural process after surgery as the body seeks to reduce inflammation and regenerate tissue…but it cannot necessarily heal what’s been taken away. So, rather than focusing on the presence of biological healing, we need to examine the extent to which it can influence a repair outcome.

The REGENETEN Implant was intended to create an environment conducive to healing and inducing the formation of tendon-like tissue growth:^6-9 an area where the debate really warms up.

Crucially, isolated bioinductive repair doesn’t require alteration of the native footprint. Instead, the intention is to support healing and tissue formation based on what already exists. This seemingly balances biomechanics and biology, theoretically allowing surgeons to achieve the benefits of both principles. This gives rise to another key topic in the debate: could more patients benefit from bioinductive repair?

Score: Biomechanics and biology are equally important, yet only one approach appears best placed to achieve both.

Round 4:
What about trans-tendon repair?

Before the debate proceeds, we can’t omit the discussion around trans-tendon repair: an alternative to takedown and repair that limits tissue removal. Typically targeting the articular side of the tendon while leaving the bursal side intact has become more popular over time.

However, trans-tendon repair is technically demanding and hinges on precise stitching when reattaching torn tendon fibers to the bone. To avoid damaging intact tendon fibers, the skill and steep learning curve involved might limit its appeal.

More importantly, despite the attempt to preserve healthy tissue it has not been proven that trans-tendon repairs are superior to traditional takedown and repair approaches, in the context of functional outcomes (notwithstanding data on re-tear rates).¹⁸ In fact, when we look at a systematic review of clinical studies comparing trans-tendon repair to traditional methods across key outcome measures, the short-term results are mixed.

• For pain and function: Trans-tendon repair patients reported higher pain levels and lower functional scores (CMS/ASES) at 3 months, compared to takedown and repair.¹⁹


• For structural integrity: Studies show no significant improvement in structural outcomes (re-tears) with trans-tendon repair, compared to traditional repairs.²⁰

Score: The increased technical difficulty and clinical results suggest that trans-tendon repair could remain a niche approach.

Round 5:
What guides rotator cuff repair approaches?

A recovery period of up to six months^21,22 can be a hard sell for patients who want and expect a return to work or everyday activities to be more immediate. Prolonged shoulder immobility and the extensive physical therapy – however important – are likely to be seen as anything from an inconvenience to a seismic disruption.

Add pain into the equation, and how any period of pain or discomfort will be considered too long, then arguments around recovery start to feed the broader discussion on what patients are likely to accept.

An article exploring the comparison between surgeons’ and patients’ expectations of rotator cuff repair does reveal some interesting gaps in perceptions. For example, it showed that an overestimation of what patients would tolerate as post-op care conflicted with the many patients who did not anticipate lengthy rehabilitation or follow-up.

Conversely, surgeons who believed patients would only accept being in hospital for 1-2 weeks was countered by some patients who would accept a period of 1 month…but likely anticipating “optimal” follow-up care.

However this may be interpreted, it does highlight that expectations of recovery are not fully aligned.

Financial cost for patients

Many patients, particularly those with manual jobs, can be out of work for anywhere between 72 and 183 days.^3,4 The financial cost depends on where patients are in the world, but in the US it can cost an average $5,800 in productivity losses due to absenteeism in the 12 months following surgery.⁴ Coupled with the stress and anxiety of financial difficulty, the conversation might transition from whether patients need surgery to whether they can afford surgery.

Patient attitudes toward rotator cuff repair

Instead of laboring on the reality of these challenges, consider the potential for patient perceptions to shift and how they might respond in the future. As patients increasingly research and seek options to minimize the impact of surgery, how long will they continue to accept lengthy recovery and potential financial loss as part of the process?

Score: There are no winners. Recovery after surgery is unavoidable, so the spotlight is on how recovery affects patients…and for how long.

Round 6:
What does the evidence say about bioinductive repair?

The principles behind any repair approach (biomechanical vs biological) are important, but the likelihood of any new approach gaining traction will always be judged by clinical data. As the more recent development, this round examines how bioinductive repair with the REGENETEN Implant has performed in evidence.

Let’s explore recent evidence highlights across a series of outcomes measures.

Score: Viewed objectively, evidence comparing bioinductive repair to standard repair approaches highlights the REGENETEN Implant as the superior option across various outcome measures.

Round 7:
What are the barriers to adopting bioinductive repair?

Taking into consideration biomechanics, biology, patient expectations and clinical data, bioinductive repair seems an increasingly promising alternative to traditional repair methods…but it has not yet surpassed takedown and repair as the prevailing choice. Let’s examine some potential reasons.

The procedure

Isolated bioinductive repair with the REGENETEN Implant involves a suture-free procedure.⁷ Adopting this approach is unlikely to slow surgeons down (fixation of the implant takes under 15 minutes, on average²⁶) so we could conclude that the time it takes to perform the procedure is not an issue.

The costs

This could be pivotal, because any change of protocol or approach carries financial implications in the form of unit costs and reimbursement.

Aside from direct costs from surgery, costs of care such as post-op rehabilitation and medication are an increasing focus. Considering all costs together could support the economic value of adopting a technique that drives improvements in the wider scope of care.

Hesitation

In the full history of partial-thickness rotator cuff repair, bioinductive repair is relatively new. There might be a decade of clinical outcomes,²⁵ but a lingering element of ‘waiting for the evidence’ could persist. This then begs the question: at what point is the evidence base considered enough?

Preferences and opportunities

This factor has the most nuance. As mentioned above, good results have been achieved and technical capabilities refined using traditional techniques. To commit to a new course of action, the evidence, costs and perceived outcomes must all align in favor.

Many surgeons are already noticing the trend toward more bioinductive repairs, with the prospect of a quicker return to work or everyday activities attracting more patients.

Score: Although barriers exist, it seems that they are, to varying degrees, surmountable.

The debate outcome

It’s important to clarify that although the debate appears to compare the advantages of two approaches, ongoing nuance and dialogue is required to transform the current standard of partial-thickness rotator cuff repair.

What the debate does reveal are some powerful points of consideration.

1. Existing techniques might be effective long-term, but have short-term limitations


2. Clinical evidence highlights potential to improve recovery times and reduce the duration of physical therapy with bioinductive repairs¹¹


3. As the flow of information continues, patient expectations will play an important role

The options are to stay the course or adopt a different approach, but will the current course hold as the debate, the evidence and the trends continue to develop?

For patients, the effects of surgery – from lengthy recovery and physical therapy to the impact on finances and quality of life – might be considered commonplace and part of the process…but only until the narrative changes.

Click here to learn more about the REGENETEN Implant in partial-thickness tear repair.