Arginine L-alpha-ketoglutarate, methylsulfonylmethane, hydrolyzed type I collagen and bromelain in rotator cuff tear repair: a prospective randomized study

Abstract

Objective:

Arthroscopic rotator cuff repair generally provides satisfactory result, in terms of decreasing shoulder pain, resulting in improvement in range of motion. Unfortunately, imaging studies have shown that after surgical repair re-rupture rate is potentially high. Literature data indicate that each of the components present in a commercial supplement sold in Italy as Tenosan(arginine L-alpha-ketoglutarate, methylsulfonylmethane, hydrolyzed type I collagen and bromelain) have a potential role in tendon healing and mitigating the pain due to tendonitis. We evaluated the clinical and MRI results of rotator cuff repair with and without the employment of this oral supplement in patients with a large, postero-superior rotator cuff tear (RCT).

Research design and methods:

We enrolled 90 consecutive patients who had a large, postero-superior RCT. All the lesions were managed with an arthroscopic repair. Patients were randomized and treated either with (Group I) or without (Group II) the supplement. The primary outcomes were the difference between the pre- and post-operative Constant score and repair integrity assessed by MRI according to Sugaya’s classification. The secondary outcome was the pre- and post-operative Simple Shoulder Test.

Results:

No statistically significant differences were identified between the two groups for each considered variable, except for shoulder pain (follow-up: 6 months) and repair integrity (final follow-up). Intensity of shoulder pain was lower in the Group I patients (p < 0.001). Analogously, in Group I, the percentage of patients with a better repair integrity result was significantly higher than Group II.

Conclusion:

The use of the supplement for 3 months after cuff repair decreases shoulder post-operative pain and leads to a slight improvement in repair integrity. This improvement does not seem to correlate with an better objective functional outcome. However, these effects could facilitate and abbreviate the post-operative rehabilitation program and reduce re-rupture rate. The main limitations of this study are the relative short follow-up period and small number of patients studied.

Level of evidence::

• Level I: High quality randomized controlled trial with statistically significant differences.

Keywords::

• Oral supplements
• Post-operative management
• Rotator cuff repair
• Tendon healing

Transparency

Declaration of funding

There are no sponsor to be declared for the study.

Declaration of financial/other relationship

There are no relationships to be declared for any of the authors.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

There is no external assistance for the study.

Notes

*Tenosan is a registered trade name of Agave farmaceutici, Bologna, Italy.