Adults 18 to 70, any sex, with Greater Trochanteric Pain Syndrome or GTPS - Greater Trochanteric Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in NRS (Numerical Rating Scale) Pain Score From Baseline (Week 0) to Week 10Primary· weeks 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.
Group
Value
95% CI
MD Tissue Collagen Medical Device
4.7
4.01 – 6.93
Mean NRS (Numerical Rating Scale) Pain Score at Week 6 and Week 24 Compared to Baseline (T0)Secondary· weeks 6 and weeks 24
Pain intensity was measured using the NRS (Numerical Rating Scale) at rest, ranging from 0 (no pain) to 10 (worst possible pain). Participants were asked to rate their pain at baseline (T0), week 6 (T6w/FU), and week 24 (T24w/FU). This outcome reports the mean NRS values at week 6 and 24. Higher scores indicate more intense pain.
NRS Week 6
Group
Value
95% CI
MD Tissue Collagen Medical Device
4.5
4.04 – 4.96
NRS Week 24
Group
Value
95% CI
MD Tissue Collagen Medical Device
2.5
2.03 – 2.97
Change in Modified Harris Hip Score (mHHS) From Baseline to Weeks 6, 10, and 24Secondary· Weeks 6, 10, and 24
The Modified Harris Hip Score (mHHS) is a validated tool for assessing hip function and pain. It ranges from 0 (worst functional outcome and highest pain) to 100 (best function and least pain). Participants were evaluated at Weeks 6, 10, and 24 compared to baseline. The change in total score is used to assess clinical improvement.
Unit of Measure:
Score from 0 to 100; higher scores indicate better outcome
T0 (Baseline)
Group
Value
95% CI
MD Tissue Collagen Medical Device
57.09
± 13.78
T6w
Group
Value
95% CI
MD Tissue Collagen Medical Device
71.22
± 11.92
T10w
Group
Value
95% CI
MD Tissue Collagen Medical Device
72.53
± 12.26
T24w
Group
Value
95% CI
MD Tissue Collagen Medical Device
73.19
± 12.74
Change in Hip Abduction Strength From Baseline to Weeks 6, 10, and 24Secondary· Weeks 6, 10, and 24
Hip abduction strength was assessed using a handheld dynamometer at Weeks 6, 10, and 24. The measurement was performed with the patient standing on the contralateral (healthy) limb, while abducting the hip affected by GTPS. For each assessment, three consecutive measurements were taken and averaged. Results were compared to baseline (Day 0) to evaluate functional improvement in muscular strength.
Row Title Number Analyzed Mean SD T0
Group
Value
95% CI
MD Tissue Collagen Medical Device
5.538
± 2.8413
T6
Group
Value
95% CI
MD Tissue Collagen Medical Device
6.045
± 2.4797
T10w
Group
Value
95% CI
MD Tissue Collagen Medical Device
6.676
± 3.0115
T24w
Group
Value
95% CI
MD Tissue Collagen Medical Device
6.851
± 2.9481
MRI Evaluation of Inflammatory and Degenerative Signs in the Peritrochanteric Region at Week 24 Compared to BaselineSecondary· Week 24 compared to baseline (Week 0)
MRI evaluation focused on inflammatory and degenerative signs in the peritrochanteric region (gluteus medius/minimus tendons) was conducted at Week 24 and compared to baseline (Week 0). Two independent radiologists assessed peri-tendinous fluid and intra-tendinous edema on STIR-weighted images. Improvement was defined as visible reduction in peritendinous edema. The analysis was qualitative and dichotomous (Improved vs. Unchanged).
Group
Value
95% CI
MD Tissue Collagen Medical Device
40
Change in Analgesic Drug Consumption (Paracetamol and/or Celecoxib) From Baseline to Week 24Secondary· 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)
Analgesic drug consumption (paracetamol and/or celecoxib) was recorded using a patient diary at time points T0 (baseline), T1w, T2w, T6w/FU, T10w/FU, and T24w/FU. Each patient logged the number of analgesic doses consumed per week. The total number of doses per timepoint was used to assess any significant change over time. The analysis aimed to evaluate whether the treatment reduced the need for pain medication, as an indirect marker of clinical efficacy.
Unit of measure: Number of analgesic doses consumed per week.
Week 1
Group
Value
95% CI
MD Tissue Collagen Medical Device
1.6
± 1.8
Week 2
Group
Value
95% CI
MD Tissue Collagen Medical Device
0.8
± 1.4
Week 6
Group
Value
95% CI
MD Tissue Collagen Medical Device
0.5
± 1.2
Week 10
Group
Value
95% CI
MD Tissue Collagen Medical Device
0.3
± 0.9
Week 24
Group
Value
95% CI
MD Tissue Collagen Medical Device
0.7
± 2.6
Incidence of Adverse Events (AE, SAE, SUSAR) From Baseline to Week 24Secondary· Day 0 to Week 24
Adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs) were monitored at each study visit from baseline (Day 0) to Week 24. Data were collected via systematic interviews and clinical assessments. No adverse events of any type were reported during the study. AE definitions followed ICH-GCP and ClinicalTrials.gov guidance.
All-Cause Mortality
Group
Value
95% CI
MD Tissue Collagen Medical Device
0
Serious Adverse Events
Group
Value
95% CI
MD Tissue Collagen Medical Device
0
Other (Non-Serious) Adverse Events
Group
Value
95% CI
MD Tissue Collagen Medical Device
0
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Guna S.p.a
Last refreshed: 14 July 2025
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