UK
Xiros USAIncreased Repair Integrity in Massive RC Tears
Pitch-Patch Rotator Cuff Reinforcing Patch
Treat massive RC tears with confidence
Maintaining the integrity of surgical repair of massive rotator cuff tears is a complex problem, with patients experiencing high re-tear rates. Pitch-Patch reinforces the repair in cases where either the soft tissue is weak, or the repair is incomplete. Published results on massive cuff tears treated with Pitch-Patch show low re-tear rates over five-year follow-up1,2.
USA and Canada
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Benefits
14% in massive cuff tears, over 5-year follow-up1,2. This is substantially below the published levels for cuff repair without augmentation or with bioresorbable patches, reported up to 94%3.
Very high strength of 355 N when fully sutured along the medial and lateral edges.
Function and pain reduction scores improved over at least five years postoperatively2.
Suitable for arthroscopic or open technique:
- Long shelf life, no special storage or pre-operative preparation.
- Anatomical design in two sizes for varying patient anatomy and tear size.
- Intra-operative decision on whether reinforcement is needed.
Indicated for patients where either the rotator cuff tear cannot be completely repaired using normal methods and/or the quality of the soft tissue is poor.
The device structure allows a natural body response whereby native tissue integrates into the device.
See surgical technique manual for full details of open or arthroscopic technique before use.
The patch is made from non-absorbable polyester (poly (ethylene terephthalate) fibres) creating a durable reinforcement for the repair. After repairing the rotator cuff tear, the surgeon selects the size of Pitch-Patch required. The medial edge of the patch is sutured to the tendon and the lateral edge then attached to the bone, typically with anchors. Anterior and posterior edges are then attached to the tendon. Once in place, the patch reinforces the tendon.
The patient can then follow the same rehabilitation plan as for the cuff repair without reinforcement, with no impact on their recovery programme. See rehabilitation guidelines.
Clinical Data Summary
A prospective study on the repair of massive cuff tears reinforced with Pitch-Patch has been conducted, with results reported at a minimum of five-years2 post surgery. The excellent functional outcomes continued to improve between the one-year and five-year timepoints (figure 1). There was only 14% re-tear rate1 and only one of those cases requiring a second surgery, compared to re-tear rates up to 94 % reported in the literature3 for repair of massive tears.
A separate retrospective study4 followed a group of patients with short tendon length (14 mm or less), with significant improvement in functional and structural outcomes. There were only three clinical failures (20%). Re-tears occurred in 53% of patients, but these were not associated with inferior outcomes compared with intact cuff repairs. Speak with a specialist for more detail on the clinical data relevant to Pitch-Patch.
Figure 1a, 1b. Shoulder function scores for rotator cuff repair augmented by Pitch-Patch, before surgery, 3-month, 1-year and 5-years post-operatively, n=50. The box plots span the interquartile range. The horizontal line inside the box represents the median. (a) Constant-Murley Scores (b) Subjective Shoulder Value scores2.
Indications
The Pitch-Patch is indicated for patients requiring reinforcement of the rotator cuff tear repair where either the tear cannot be completely repaired using normal methods and / or the quality of the soft tissue is poor.
The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff following or during repair by suture or suture anchors, where weakness exists in the soft tissue.
The Pitch-Patch is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair. The Pitch-Patch reinforces the rotator cuff and provides a scaffold that is incorporated into the patient’s own tissue.
Instructions for Use
To view the instructions for use please visit our IFU library
Order Codes
102-1090XI Pitch-Patch, standard, 30 mm x 20 mm
102-1091XI Pitch-Patch, large, 35 mm x 25 mm
Frequently Asked Questions
Can I use the patch if the repair is incomplete?
Yes, Pitch-Patch is indicated in repairs that cannot be completely repaired using standard methods, as long as it is augmenting the repair and not bridging. The strength of the device is measured when attached to sutures and the minimum strength (355N) is suitable for reinforcing the repair of torn tendon.
Can I use the patch to bridge a gap if I cannot close the repair
No, Pitch-Patch is not indicated for bridging or interposition. It is for augmentation.
Can I use the patch with an open technique and then learn the arthroscopic method?
Yes, the two methods are different, but use the same implant. Contact us for more information on training.
Can I switch from arthroscopic approach to open approach during a procedure and then use the patch?
Yes, the Pitch-Patch can be used with open or arthroscopic method. Arthroscopic method uses a “parachute” technique to place the device. A decision to change to open approach should ideally be made before the parachute sutures are set up.
Are there any special rehabilitation requirements?
There are no special requirements. The patient can follow the same rehabilitation programme as for a primary rotator cuff repair.
What happens to the Pitch-Patch over time?
Pitch-Patch is gradually encapsulated after a minimal acute inflammatory reaction. Unlike certain biological implants, the polyester material does not cause any immunological reaction. It then integrates well with the patient’s tissues. It is not absorbed, no is any significant change in tensile strength known to occur in vivo.
Pitch-Patch is permanent, can it be removed?
Pitch—Patch has been shown to integrate well with the patient’s tissue. Tissue incorporates between and around the polyester fibres. In the study by Smolen et al seven revisions were successfully carried out, removing the implant where required. It may not be a suitable option where eventual removal of the device is planned or anticipated.
Does a permanent implant lead to crepitus or frozen shoulder?
Published clinical data reports the levels of complications including frozen shoulder, arthrofibrosis and crepitus. Xiros also collect post-market data. The levels of all such complications recorded to date are within the expected levels for rotator cuff repair with or without patch augmentation.
How can I obtain training on the Pitch-Patch technique?
Xiros run periodic training courses and have access to a range of training material. Depending on location and situation, we may also be able to connect you with a surgeon who uses Pitch-Patch. Please contact us to discuss your requirements.
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Additional Information
For further information, and for details of local distributors and agents, contact our Sales and Marketing team at enquiries@xiros.co.uk
All data listed on this page is held at Xiros and can be requested by contacting enquiries@xiros.co.uk
To request the full range of product documentation or to view any of these documents in a language other than English, please contact us for availability
Always refer to the Instructions for Use which contains detailed information and essential warnings and precautions
- Smolen D, et al. (2020). Application of a new polyester patch in arthroscopic massive rotator cuff repair-a prospective cohort study. J Shoulder Elbow Surg, 29(1), e11-e21.
- Hess F, Welter J, Jaberg L (2023). Long-Term Outcomes Following Synthetic Patch Augmentation to Treat Rotator Cuff Tears, Trauma International, 9(1), 01-04.
- Xiros data on file, Clinical Evaluation Report, Pitch-Patch.
- Dommer LM,et al (2023), Massive rotator cuff tears with short tendon length can be successfully repaired using synthetic patch augmentation, J Shoulder Elbow Surg 32, 2089–2096