Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery
- Registration Number
- NCT01022242
- Lead Sponsor
- Pergamum AB
- Brief Summary
The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II.
- Detailed Description
This is a multi-centre, randomized, double blind, parallel study design in patient admitted for flexor tendon repair in zone II.
The patients will undergo 9 visits within the time frame of the study. Patients will be randomized to receive treatment with PXL01 or standard care.
Primary objective is to assess total active motion based on PIP and DIP joints (TAM2) at 12-week visit. Secondary objectives are to assess TAM2 at all time points except for 12 weeks, TAM based on MCP, PIP, and DIP joints (TAM3) at all time points, Total Active Motion in DIP joint (DIPAM), tip-to-crease, grip strength and Total Passive Motion (TPM2 and TPM3).
Before any study-related assessment takes place, patients are given verbal and written information about the study and informed consent is achieved from the patient and/or legal guardian. The study should be carried out in accordance with the Clinical Study Protocol (CSP), ICH guidelines for Good Clinical Practise (GCP), and applicable regulatory requirements.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. PXL01 PXL01 PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
- Primary Outcome Measures
Name Time Method TAM2 At 12 weeks after surgery The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Dept. of Hand Surgery Uppsala University Hospital, entrance 70
🇸🇪Uppsala, Sweden
Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie
🇩🇪Duisburg, Germany
Dept. of Hand Surgery Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie
🇩🇪Homburg, Germany
Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern
🇩🇪Munich, Germany
Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH
🇩🇪Stuttgart, Germany
Dept. of Hand Surgery, Aalborg Hospital
🇩🇰Aalborg, Denmark
St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie
🇩🇪Essen, Germany
Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt
🇩🇪Munich, Germany
Dept. of Hand Surgery, Odense University Hospital
🇩🇰Odense, Denmark
Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH
🇩🇪Bad Neustadt, Germany
Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte
🇩🇪Lübeck, Germany
Dept. of Hand Surgery, Stockholm South General Hospital
🇸🇪Stockholm, Sweden
Dept. of Hand Surgery Malmö University Hospital
🇸🇪Malmö, Sweden