Trial Outcomes & Findings for Evaluation of the Efficacy of the Use MD Tissue Collagen Medical Device in the Infiltrative Treatment of Greater Trochanter Pain Syndrome (GTPS) (NCT NCT05486078)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

weeks 10

Results posted on

2025-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	MD Tissue Collagen Medical 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.
Overall Study STARTED	47
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	MD Tissue Collagen Medical 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.
Overall Study 4 drop out and one withdrawn	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MD-Tissue Medical Device n=47 Participants MD Tissue Collagen Medical 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.
Age, Categorical <=18 years	0 Participants n=47 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=47 Participants
Age, Categorical >=65 years	0 Participants n=47 Participants
Sex: Female, Male Female	42 Participants n=47 Participants
Sex: Female, Male Male	5 Participants n=47 Participants

PRIMARY outcome

Timeframe: weeks 10

Population: All variables will be subjected to the appropriate descriptive analyses after validation of the input data. Continuous variables: mean ± standard deviation or median and range, depending on the distribution; categorical variables: absolute and relative frequency tables.

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.

Outcome measures

Outcome measures
Measure	MD Tissue Collagen Medical Device n=47 Participants 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.
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 Interval 4.01 to 6.93

SECONDARY outcome

Timeframe: weeks 6 and weeks 24

Population: All variables were subjected to the appropriate descriptive analyses after validation of the input data. Continuous variables were analyzed as mean ± standard deviation or median and range, depending on the distribution. Categorical variables were summarized as absolute and relative frequency tables.

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.

Outcome measures

Outcome measures
Measure	MD Tissue Collagen Medical Device n=47 Participants 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.
Mean NRS (Numerical Rating Scale) Pain Score at Week 6 and Week 24 Compared to Baseline (T0) NRS Week 6	4.5 score on a scale Interval 4.04 to 4.96
Mean NRS (Numerical Rating Scale) Pain Score at Week 6 and Week 24 Compared to Baseline (T0) NRS Week 24	2.5 score on a scale Interval 2.03 to 2.97

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	MD Tissue Collagen Medical Device n=43 Participants 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.
Change in Modified Harris Hip Score (mHHS) From Baseline to Weeks 6, 10, and 24 T0 (Baseline)	57.09 Score from 0 to 100; higher scores indic Standard Deviation 13.78
Change in Modified Harris Hip Score (mHHS) From Baseline to Weeks 6, 10, and 24 T6w	71.22 Score from 0 to 100; higher scores indic Standard Deviation 11.92
Change in Modified Harris Hip Score (mHHS) From Baseline to Weeks 6, 10, and 24 T10w	72.53 Score from 0 to 100; higher scores indic Standard Deviation 12.26
Change in Modified Harris Hip Score (mHHS) From Baseline to Weeks 6, 10, and 24 T24w	73.19 Score from 0 to 100; higher scores indic Standard Deviation 12.74

SECONDARY outcome

Timeframe: Weeks 6, 10, and 24

Population: All patients who completed dynamometric testing at all timepoints (T0, T6, T10, T24) were included in the per-protocol analysis.

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.

Outcome measures

Outcome measures
Measure	MD Tissue Collagen Medical Device n=43 Participants 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.
Change in Hip Abduction Strength From Baseline to Weeks 6, 10, and 24 Row Title Number Analyzed Mean SD T0	5.538 Force in kg measured by handheld dynamom Standard Deviation 2.8413
Change in Hip Abduction Strength From Baseline to Weeks 6, 10, and 24 T6	6.045 Force in kg measured by handheld dynamom Standard Deviation 2.4797
Change in Hip Abduction Strength From Baseline to Weeks 6, 10, and 24 T10w	6.676 Force in kg measured by handheld dynamom Standard Deviation 3.0115
Change in Hip Abduction Strength From Baseline to Weeks 6, 10, and 24 T24w	6.851 Force in kg measured by handheld dynamom Standard Deviation 2.9481

SECONDARY outcome

Timeframe: Week 24 compared to baseline (Week 0)

Population: Patients who underwent MRI evaluation both at baseline and at Week 24 were included in the analysis (n=40).

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).

Outcome measures

Outcome measures
Measure	MD Tissue Collagen Medical Device n=40 Participants 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.
MRI Evaluation of Inflammatory and Degenerative Signs in the Peritrochanteric Region at Week 24 Compared to Baseline	40 Participants with MRI improvement

SECONDARY outcome

Timeframe: 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)

Population: All participants who returned complete analgesic diaries at each visit (Weeks 1, 2, 6, 10, and 24) were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MD Tissue Collagen Medical Device n=43 Participants 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.
Change in Analgesic Drug Consumption (Paracetamol and/or Celecoxib) From Baseline to Week 24 Week 1	1.6 Units of analgesics consumed (number of Standard Deviation 1.8
Change in Analgesic Drug Consumption (Paracetamol and/or Celecoxib) From Baseline to Week 24 Week 2	0.8 Units of analgesics consumed (number of Standard Deviation 1.4
Change in Analgesic Drug Consumption (Paracetamol and/or Celecoxib) From Baseline to Week 24 Week 6	0.5 Units of analgesics consumed (number of Standard Deviation 1.2
Change in Analgesic Drug Consumption (Paracetamol and/or Celecoxib) From Baseline to Week 24 Week 10	0.3 Units of analgesics consumed (number of Standard Deviation 0.9
Change in Analgesic Drug Consumption (Paracetamol and/or Celecoxib) From Baseline to Week 24 Week 24	0.7 Units of analgesics consumed (number of Standard Deviation 2.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MD Tissue Collagen Medical Device n=43 Participants 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.
Incidence of Adverse Events (AE, SAE, SUSAR) From Baseline to Week 24 Serious Adverse Events	0 participants
Incidence of Adverse Events (AE, SAE, SUSAR) From Baseline to Week 24 All-Cause Mortality	0 participants
Incidence of Adverse Events (AE, SAE, SUSAR) From Baseline to Week 24 Other (Non-Serious) Adverse Events	0 participants

Adverse Events

MD Tissue Collagen Medical Devic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vincenzo Miranda, Clinical Research & Scientific Service Manager

Guna S.p.a

Phone: 02 280.18.(358)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place