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Lipofilling in Surgery of Proximal Phalanx Fractures and Related Tenolysis

Perioperative Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis: Improving Range of Motion - Lipofilling in Surgery of Proximal Phalanx Fractures and Related Tenolysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57006
Enrollment
130
Registered
2024-09-10
Start date
2026-07-01
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

Adhesions, Stiffness Stiffness

Interventions

Patients will either receive 1ml of subcutaneous micronised lipofilling or 1ml subcutaneous 0,9% NaCl around the operation site at the end of the ORIF or tenolysis

Sponsors

Jeroen Bosch Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Aged 18-65 years  • Indication for one of the following surgical procedures: o ORIF due to a single radiologically proven P1 fracture o Secondary tenolysis due to limited digital function after former operative  treatment of a P1 fracture  • Able to read and speak Dutch • Mentally competent

Exclusion criteria

Exclusion criteria: • Aged below 18 or above 65 years  • Concomitant tendinous or neurovascular injuries • Prior surgical interventions of the affected digit; other than operative  fracture fixation in case of tenolysis • Prior pathology or surgical interventions of the contralateral digit • Less than 3 months of competent hand therapy in case of secondary tenolysis  • A known psychiatric condition • A known systemic disease that will impair wound healing (e.g. diabetes  mellitus, known atherosclerosis with an event that required hospitalization,  collagen diseases, diseases of the skin, HIV).  • Prednisone or other immunotherapy  • Smoking  • Pregnancy or active child wish

Design outcomes

Primary

MeasureTime frame
1. In case of an indication for ORIF of P1 fractures the following parameters will be assessed: • Preoperative - Total active motion (TAM) of the contralateral unaffected digit. • 6 weeks, 3 months and 6 months postoperative - TAM of the operated digit and the contralateral unaffected digit. 2. In case of tenolysis after operative treatment of P1 fractures the following parameters will be assessed: • Preoperative - TAM of the affected digit and the contralateral unaffected digit; • 6 weeks, 3 months and 6 months postoperative - TAM of the operated digit and the contralateral unaffected digit;

Secondary

MeasureTime frame
1. In case of an indication for ORIF of P1 fractures the following parameters will be assessed: • Preoperative - Active range of motion (AROM) and passive range of motion (PROM) of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal (MCP-, PIP- and DIP) joint of the contralateral unaffected digit. • 2 weeks, 6 weeks, 3 months and 6 months postoperative - NRS-score of the abdominal donor site.• 6 weeks, 3 months and 6 months postoperative - AROM and PROM of the MCP-, PIP- and DIP-joint of the operated digit and the contralateral unaffected digit; - MHQ-score.• 6 months postoperative - Radiographic union of the operated digit.• During the 6 months postoperative period - Postoperative complications, including infection, wound-related problems, and stiffness; - Number of secondary procedures, including tenolysis. 2. In case of tenolysis after operative treatment of P1 fractures the following parameters will be assessed: • Preoperative - AROM and PROM of the MCP-, PIP- and DIP-joint of the affected digit and the contralateral unaffected digit; - MHQ-score. • 2 weeks, 6 weeks, 3 months and 6 months postoperative - NRS-score of the abdominal donor site. • 6 weeks, 3 months and 6 months postoperative - AROM and PROM of the MCP-, PIP- and DIP-joint of the operated digit and the contralateral unaffected digit; - MHQ-score. • During the 6 months postoperative period - Postoperative complications, including infection, wound-related problems and stiffness.

Countries

Netherlands

Contacts

Public ContactB.C.J.M. Vries

Jeroen Bosch Ziekenhuis

bar.d.vries@jbz.nl(073) 553 60 15

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026