Total hip replacement
Conditions
Interventions
Trade Name: Phlogenzym
Product Name: Phlogenzym
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Trypsin
CAS Number: 9002-07-7
Other descriptive name: TRYPSIN
Concentration unit: mg milligram(s
Sponsors
MUCOS Pharma CZ s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease. 2. The patient has signed an Informed Consent Form, approved by the EC and CA. 3. The patient is a male or non-pregnant female age 50 years or older at time of arthroplasty. 4. The patient is a candidate for a primary cementless total hip replacement via anterolateral approach in spinal (subarachnoidal) anesthesia. 5. There are no contraindications for planned concomitant medication. 6. The patient is willing and able to comply with postoperative scheduled clinical evaluations and rehabilitation. 7. The patient agrees to abstain from smoking from the signing of the informed consent till the discharge from the hospital. 8. Anticipated uncomplicated operation course as per Investigator´s judgment. 9. Female subjects in the fertile ageWomen of childbearing potential, unless practicing sexual abstinence, must take adequate contraceptive measures: a barrier method in combination with spermicide or per-oral contraception or IUD with an exception of women who are post-menopausal or are not of child bearing potential. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. The patient has a Body Mass Index (BMI) = 20 and =35. 2. The patient has an active or suspected latent infection in or about the affected hip joint at the time of the implantation. 3. The patient has a baseline CRP value > 6 mg/l. 4. The patient has been a tobacco smoker for any time within the last 12 months. 5. The patient has a neuromuscular or neurosensory deficiency, which limits the validity of the assessment procedures. 6. The patient is diagnosed with a systemic disease (e.g. rheumathoid arthritis, lupus erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration. 7. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (at least 30 days before study). 8. Planned mini-incision or other than anterolateral approach operation. 9. The patient requires revision operation of a previously implanted total hip replacement or hip fusion to the affected joint. 10. The patient has a known sensitivity to device materials or Phlogenzym® or Placebo. 11. Pregnancy or nursing. 12. Insulin dependent DM. 13. Contraindication of Xarelto® or history of intolerance of Xarelto®.®; otherwise, there is no prohibited concomitant medication. 14. Participation or planned participation in another clinical study. 15. Inborn or acquired hemocoagulation disorders (hemophilia, severe liver dysfunction). 16. The patient is on hemodialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to explore the validity and clinical feasibility of methods for assessment of perioperative efficacy of Phlogenzym? in terms of symptoms of systemic (CRP, hemocoagulation) and local inflammation and short- and mid-term course of rehabilitation, with the aim to select the primary and secondary endpoints for an intended confirmatory study.;Secondary Objective: Not applicable;Primary end point(s): 1. C-reactive protein in serum, AUC from Day 1 through Day 7 following operation, 2. values of selected hemocoagulation parameters in plasma (anti Xa, Quick, APTT, fibrinogen), 3. blood transfusion volume during operation, 4. blood transfusion volume after operation, 5. cumulative Redon drain discharge volume till 48 hours after operation, 6. thigh and calf circumference, AUC from Day 1 through Day 7 following operation, 7. body temperature in axilla, AUC from Day 1 through Day 7 following operation, 8. local pain at rest, self-rated on the 10 cm Visual Analogue Scale (VAS), AUC from Day 1 through Day 7after operation, 9. knee extension strength, on Day 5 and Day 7 after operation, 10. frequency of any rescue analgesic medication through Day 1 to Day 7 after operation. ;Timepoint(s) of evaluation of this end point: Postoperative period: 1 till 7 days postoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. thigh and calf circumference, assessments on Day 7, Day 14, Day 28 and Day 42 after operation, 2. Harris Hip Score (HHS), assessments on Day 7, Day 14, Day 21, Day 28 and Day 42, 3. performance in timed Up&Go Test (TUG), assessments on Day 7, Day 14, Day 21, Day 28 and Day 42, 4. knee extension strength, assessments on Day 7, Day 14, Day 21, Day 28 and Day 42, 5. local pain at rest (VAS), assessments on Day 7, Day 14, Day 21, Day 28 and Day 42, 6. cumulative consumption of the rescue analgesics (number of doses) from Day 7 till Day 42, 7. cumulative number of analgesics-free days from Day 7 till Day 42, 8. Clinical Global Impression of Change – patient’s and Investigator’s assessment of change from the first postoperative day done on Day 7, Day 14, Day 21, Day 28 and Day 42. ;Timepoint(s) of evaluation of this end point: Rehabilitation period: 7 till 42 days postoperative | — |
Countries
Czech Republic
Contacts
Public ContactClinical department
MUCOS Pharma CZ
Outcome results
None listed