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A Study of Atelocollagen Muscle Injection to Support Recovery After Hip Fracture Surgery

Intramuscular Atelocollagen Injection Therapy for Recovery After Hip Fracture Surgery: A Single-Center Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0012114
Enrollment
78
Registered
2026-06-12
Start date
2026-06-12
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Participants undergoing hip arthroplasty for hip fracture will be randomly assigned to either the atelocollagen injection group or the placebo injection group. In the atelocollagen gr

Sponsors

Inha University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 60 to 90 years 2. Patients with hip fracture caused by low-energy trauma 3. Patients scheduled to undergo total hip arthroplasty or hemiarthroplasty 4. Patients with an American Society of Anesthesiologists physical status classification of III or lower 5. Patients who were able to walk before the fracture, with or without an assistive device 6. Patients who voluntarily provide written informed consent after receiving sufficient explanation of the study purpose and procedures 7. Patients who meet all of the above inclusion criteria

Exclusion criteria

Exclusion criteria: 1. Patients with severe musculoskeletal, neurological, or neuromuscular disease 2. Patients with pathological fracture caused by bone disease other than osteoporosis 3. Patients with uncontrolled diabetes mellitus, for example HbA1c > 10% 4. Patients with active infection or severe autoimmune disease 5. Patients with severe hepatic or renal dysfunction 6. Patients who do not agree to participate in this study 7. Patients with severe psychiatric illness, such as severe depression, that may affect study participation 8. Patients judged by the principal investigator or study investigator to be medically inappropriate for participation in this study

Design outcomes

Primary

MeasureTime frame
Change in Short Physical Performance Battery (SPPB) total score from baseline to week 26

Secondary

MeasureTime frame
Change in hip abductor strength;Change in Lower Extremities Measure (LEM) score;Changes in body composition parameters;Changes in gluteus medius ultrasound parameters;Changes in quality of life measures;Changes in pain measures;Changes in grip strength;Changes in gait and motion analysis measures

Countries

Korea, Republic of

Contacts

Public ContactJUN IL YOO

Inha University Hospital

ooys0603@gmail.com+82-32-890-0807

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jun 21, 2026