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N/A N=47 Treatment

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

Greater Trochanteric Pain Syndrome · GTPS - Greater Trochanteric Pain Syndrome · Tendon Disorder · Pertrochanteric Fracture · Gluteal Tendinitis

Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in NRS (Numerical Rating Scale) Pain Score From Baseline (Week 0) to Week 10 — 4.7 NRS Pain Score (range 0-10; higher score

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
MD Tissue Collagen Medical Device (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Guna S.p.a
Primary completion
May 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in NRS (Numerical Rating Scale) Pain Score From Baseline (Week 0) to Week 10
4.7
SECONDARY
Mean NRS (Numerical Rating Scale) Pain Score at Week 6 and Week 24 Compared to Baseline (T0)
4.5; 2.5
SECONDARY
Change in Modified Harris Hip Score (mHHS) From Baseline to Weeks 6, 10, and 24
57.09; 71.22; 72.53; 73.19
SECONDARY
Change in Hip Abduction Strength From Baseline to Weeks 6, 10, and 24
5.538; 6.045; 6.676; 6.851 0.001 sig
SECONDARY
MRI Evaluation of Inflammatory and Degenerative Signs in the Peritrochanteric Region at Week 24 Compared to Baseline
40 < 0.0001 sig
SECONDARY
Change in Analgesic Drug Consumption (Paracetamol and/or Celecoxib) From Baseline to Week 24
1.6; 0.8; 0.5; 0.3; 0.7 0.992
SECONDARY
Incidence of Adverse Events (AE, SAE, SUSAR) From Baseline to Week 24
0; 0; 0

Summary

Greater Trochanteric Pain Syndrome, also known as GTPS (Greater Trochanteric Pain Syndrome) is a complex clinical condition characterized by chronic and recurrent pain in the lateral region of the hip, near the greater trochanter of the femur. Biomechanical and anatomic-histologic interactions of the structures of the peri trochanteric space, in which, given the close anatomic-functional relationships, the origin can be traced to three different pathologic entities that may influence each other and fuel the progressive exacerbation of symptomatology. These are: external snap hip, trochanteric bursitis, and tendinopathies of the tendons of the gluteus mediums and gluteus minimums muscles. Recent studies regarding GTPS have shown that in most cases this condition is due to degenerative tendinopathy of the tendons of the gluteus minimums and gluteus mediums muscles. Tendinopathy is defined as a pathological condition associated with histological changes that may result in a change in the organization of collagen fibrils, relative increase in the percentage of proteoglycans, glycosaminoglycans, and no collagenous components of the ECM accompanied by neo-vascularization and inflammatory state. Tendinopathies thus result in painful symptomatology that very often also results in biomechanical functional deficit. Clinically, GTPS presents as pain that is often debilitating and exacerbated by activities such as walking, climbing stairs, and lying on the affected side at night, associated with a progressive loss of stenia in hip abduction movements. On objective examination, a point of tenderness (trigger point) is noted at the level of the region of the greater trochanter, which may radiate to the lumbar area and along the lateral aspect of the thigh to the ipsilateral knee and a difficulty on strength versus resistance tests in hip abduction movements. Although it is a very common syndrome, the treatment of painful grand trochanter syndrome, as well as that of tendinopathies in general, is still a major hurdle because the specific cellular pathogenetic and biomechanical etiopathogenetic mechanisms are still partly unknown and many treatments are empirical. Traditionally, the treatment of GTPS is initially conservative and includes rest, ice, NSAIDs and physiotherapy with stretching exercises of the fascia late. The use of corticosteroids, with systemic or local infiltrative intake, for the treatment of tendinopathies is highly controversial and, in any case, does not seem to have long-term efficacy. MD-Tissue Collagen Medical Device is an injectable medical device based on porcine collagen type I; the collagen content is 100µg/2mL. Porcine collagen is like human collagen and highly compatible; it has very low risks of inducing adverse effects and is therefore used in several clinical settings.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05486078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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