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

NCT05486078 | Completed Results

• 1 other identifier: MDG2020711
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

MD-Tissue Collagen Medical; Ecoguide; Biomechanical; Modified Harris Hip Score; Numeric Rating Scale; Type I collagen

Outcome Measures

Primary Outcomes (1)

• Change in NRS (Numerical Rating Scale) Pain Score From Baseline (Week 0) to Week 10

  Pain intensity was measured using the NRS (Numerical Rating Scale), a validated scale ranging from 0 (no pain) to 10 (worst possible pain). Participants were asked to indicate their pain level at baseline (Week 0) and at Week 10. A change of at least 3 points on the NRS is considered clinically significant. The primary outcome is the mean change in NRS score from baseline to Week 10.

  weeks 10

Secondary Outcomes (6)

• Mean NRS (Numerical Rating Scale) Pain Score at Week 6 and Week 24 Compared to Baseline (T0)

  weeks 6 and weeks 24

• Change in Modified Harris Hip Score (mHHS) From Baseline to Weeks 6, 10, and 24

  Weeks 6, 10, and 24

• Change in Hip Abduction Strength From Baseline to Weeks 6, 10, and 24

  Weeks 6, 10, and 24

• MRI Evaluation of Inflammatory and Degenerative Signs in the Peritrochanteric Region at Week 24 Compared to Baseline

  Week 24 compared to baseline (Week 0)

• Change in Analgesic Drug Consumption (Paracetamol and/or Celecoxib) From Baseline to Week 24

  Week 1, Week 2, Week 6, Week 10, and Week 24 compared to baseline (Week 0) Week 1, Week 2, Week 6, Week 10, and Week 24 compared to baseline (Week 0) Week 1, Week 2, Week 6, Week 10, and Week 24 compared to baseline (Week 0)

Study Arms (1)

MD-Tissue Medical Device

EXPERIMENTAL

Device: MD Tissue Collagen Medical Device

Interventions

MD Tissue Collagen Medical Device DEVICE

The Experimental Group will be treated with 2-mL volume ultrasound-guided infiltration of: MD-Tissue (GUNA, Milan-Italy). Composition for 2 ml: collagen 100 micrograms Subjects will be treated with No.1 infiltration per week for 3 consecutive weeks. The infiltrations will be performed in an echoguided mode. MD-Tissue Collagen Medical Device will be infiltrated into the trochanteric bursa and at the level of the tendons of the gluteus minimus and gluteus medius, particularly at the level of the most degenerated insertional areas.

MD-Tissue Medical Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guna S.p.a: lead

Study Sites (1)

Gaetano Pini CTO

Milan, MI, 20122, Italy

Location

MeSH Terms

Conditions

Tendinopathy; Osteogenesis Imperfecta, Type IV

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Limitations and Caveats

The limitations are constituted by the monocentric nature, the short follow-up and the absence of PROMs dedicated to hip tendon pathology. This last factor could induce a ceiling effect at the mHHS. Larger studies with longer follow-ups are desirable to try to find a final solution to this ubiquitous and disabling pathology.

Results Point of Contact

• Title: Dr. Vincenzo Miranda, Clinical Research & Scientific Service Manager
• Organization: Guna S.p.a

v.miranda@guna.it

02 280.18.(358)

Study Officials

• Randelli RFMN Filippo Maria Nicola, Prof

  Gaetano Pini CTO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One sample study

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: August 3, 2022
• Study Start: September 13, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)