Evaluation of the Efficacy of the Use MD Tissue Collagen Medical Device in the Infiltrative Treatment of Greater Trochanter Pain Syndrome (GTPS)

This is a pilot monocentric Clinical Investigation based on a One sample design.

In the ex vivo study, MD-Tissue Collagen Medical Device was used as a substrate for cell cultures of human gluteal tenocytes on culture plates. The results suggest how MD-Tissue can induce an anabolic phenotype in tenocytes by stimulating their proliferation and migration; it would also be able to promote the synthesis, maturation, and secretion of COL-I, thereby promoting tendon homeostasis and repair. Specifically, the modification of gene expression and proteins involved in collagen turnover pathways were analyzed by real-time PCR, Slot blot and SDS-zymography. Data from the study showed that tenocytes cultured with MD-Tissue compared with controls exhibited increased secretion and migration of COL-1 increased mRNA levels of the matrix metalloprotease inhibitor proteins MMP-1 and TIMP-1.

The tenocytes used for the cell cultures were gluteal tenocytes, derived from human gluteal tendon fragments (obtained from subjects without any tendon pathology who had undergone total hip replacement surgery); therefore, it is reasonable to think that the porcine type I collagen-based compound may be a viable treatment in GTPS.

The results of the preclinical study suggest how MD-Tissue Collagen Medical Device can induce an anabolic phenotype in tenocytes by stimulating tenocyte proliferation and COL-I synthesis, maturation, and secretion, thereby promoting tendon repair. As these effects have been evaluated ex vivo on tenocytes of gluteal muscle tendons, the purpose of this study is to evaluate its efficacy in local infiltrative treatment, in the pertechnetic region, of GTPS, in terms of resolution of pain symptoms and recovery of stenia in abduction.

Variables will be assessed at 6 different times; at baseline (day 0), after week 1, weeks 2, weeks 6, weeks 10 and after weeks 24.

Inclusion criteria

• Male and female subjects aged 18 to 70 years;
• subjects with lateral palpatory pain that has appeared for at least 1 month;
• subjects with hip pain symptomatology assessed by Numerical rating scale (NRS) ≥ to 5;
• Subjects able to cooperate for the assessments in the Survey plan;
• subjects able to understand and sign informed consent.

Exclusion criteria

• subjects with true coxalgia (with positive FADDIR);
• subjects with ESHS (external snap hip syndrome);
• subjects already undergoing candidate hip replacement surgery;
• subjects with radiologic and clinical evidence of small and/or middle gluteal tendon detachment with indication for surgical repair;
• subjects with evidence of radiographically documented tendon calcifications;
• subjects with a degree of coxarthrosis of the hip that is a candidate for treatment according to the classification of Tonnis>1
• subjects who have taken fluoroquinolones within 30 days prior to enrollment
• subjects who have undergone treatment with hyaluronic acid or corticosteroids in the hip candidate for infiltrative treatment within 4 weeks before enrollment;
• subjects with local infections of the treatment candidate hip or systemic infections, osteomyelitis, or sepsis;
• subjects on chronic treatment with corticosteroids or immunosuppressants;
• subjects who are drug addicts, alcoholics, have psychiatric disorders, or have clinical conditions that may compromise the correct interpretation of PROMs or follow-up;
• subjects with coagulopathies, platelet aggregation disorders, or on treatment with oral anticoagulants or antiplatelets that cannot be discontinued during the study period;
• Pregnant and lactating subjects (female subjects of childbearing age should be tested for pregnancy before enrollment);
• subjects with allergy to porcine collagen.