Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT01562366
Eligibility Criteria:
Inclusion Criteria:
1. Female or male aged between 40-70 years old, females and males are eligible
2. A history of \> 6 months of conservative care treatment for lateral hip pain, including but not limited to local anaesthetic and steroid injections into the trochanteric bursa
3. Pre-operative MRI and ultrasound with evidence of GTPS within the previous 24 weeks
4. Willing to comply with the protocol and follow-up visits
5. Signed the Independent Ethics Committee (IEC) approved Informed Consent Form
Exclusion Criteria:
1. Previous surgery to the hip such as hip replacement, fracture neck of femur fixation, or repair of gluteal tendons
2. Subjects with sero-positive or sero-negative arthropathy
3. Long term steroid use \> 6 weeks
4. Allergy to drugs to be used in the procedure
5. Medical co-morbidities that preclude surgical intervention
6. Inability to understand or respond to the study questionnaires
7. Females who are pregnant, or pregnancy is suspected or planned within the clinical investigation timeframe
8. Subjects who are simultaneously participating in another device or pharmaceutical investigation
Intra-operative Exclusion:
1. Abductor tears
2. Severe tendinopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01562366
Study Brief:
Protocol Section:
NCT01562366