A clinical trial to compare study drug versus dummy treatment (placebo) in flexor tendon surgery in which the method for analysing data has been specified in the protocol before the study has begun (prospective),the patients have been randomly assigned to receive either the study drug or dummy treatment (placebo), and in which neither the patient nor the physician conducting the study know which treatment is beinggiven to the patient.
- Conditions
- Patients with flexor tendon injuries in zone I or IIMedDRA version: 14.1Level: PTClassification code 10043248Term: Tendon ruptureSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2009-012703-25-DE
- Lead Sponsor
- Pergamum AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 138
The following entry criteria apply:
1. Complete division of flexor digitorium profundus tendon (FDP) in zone I or II, with or without division of the flexor digitorium superficialis (FDS) and possible to rejoin with tendon suture
2. Open flexor tendon injury sutured within 14 days after trauma
3. 18-75 years of age
4. Signed informed consent prior to any study related procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
If one or more of the following criteria are fulfilled, the patient should not be included in the study:
1. Treatment with any investigational product within 4 weeks of study entry
2. Patients previously included in the study
3. Thumbs with complete or partial division of flexor pollicis longus (FPL)
4. Concomitant fracture(s) requiring immobilisation
5. Injuries with associated soft tissue loss
6. Severe crush injury
7. Palmar plate injury requiring immobilisation
8. Devascularisation/requirement of vascular repair
9. Joint injuries
10. Bilateral injuries
11. Previous flexor tendon surgery in the digit, which is to be treated wih IMP
12. Reduced motion in the digit, which is to be treated with IMP, or the corresponding digit prior to the injury
13. Compliance with mobilisation protocol not expected
14. Alcohol or drug abuse
15. Severe intercurrent illness, which in the opinion of the Investigator, may put the patient at risk when participating in the study, or affect the patient’s ability to take part in the study
16. Pregnant or lactating females
17. Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner during the first two weeks post-surgery. A condom alone is not considered an acceptable method for birth control, not even together with spermicide.
18. Known allergy to any component of the study product or placebo
19. Patients suffering from:
- Diabetes Mellitus patients where significant diabetic complications may delay healing according to the investigator’s judgement
- Rheumatoid arthritis
20. Or patients treated with:
- Systemic steroids within one month
- Immunosuppressive drugs within three months
- Daily use of NSAIDs within one week or occasional use within 8 hours
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate the efficacy of a single local administration of 20 mg/ml PXL01 in sodium hyaluronate in patients with a flexor tendon injury in zone I or II. ;Secondary Objective: The secondary objectives are to evaluate additional efficacy variables and safety, including rupture rate, of a single local administration of 20 mg/ml PXL01 in sodium hyaluronate in patients with a flexor tendon injury in zone I or II. Exploratory analysis of prognostic factors and covariates of Poor Responders will be performed. In addition, the IMP users’ thoughts about product handling and administration will be evaluated.;Primary end point(s): The primary variable is Total Active Motion (TAM) at the proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints (i.e. TAM2) of the affected digit at actively made fist.;Timepoint(s) of evaluation of this end point: 12 weeks after surgery
- Secondary Outcome Measures
Name Time Method