E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Revision total hip arthroplasty |
Reimplantace totální endoprotézy kyčelního kloubu |
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E.1.1.1 | Medical condition in easily understood language |
Re-operation for total hip joint prosthesis |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10044088 |
E.1.2 | Term | Total hip replacement |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The goal of this study is to assess the safety and the efficacy of beta-tricalcium phosphate biomaterial containing autologous mesenchymal stem cells. PrimaryObjective - Safety: To document absence of complication at the site of femoral bone defect. To assess overal profile of untoward events in study subjects. |
Cílem této studie je zhodnocení bezpečnosti a účinnosti beta-trikalciumfosfátového biomateriálu obsahujícího autologní nezenchymální kmenové buňky při léčení kostních defektů. Primární cíl - bezpečnost: Ověření absence komplikací v mistě ošetřeného kostního defektu stehenní kosti, dále zhodnocení případných celkových zdravotních komplikací pacientů. |
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E.2.2 | Secondary objectives of the trial |
Safety: Incidence of other study treatment-emergent adverse events. Overal safety. Efficacy: To assess the quality of healing of femoral bone defects as evaluated by Harris Hip Score, plain X-rays and densitometry, in comparison to referral data. |
Bezpečnost: Výskyt nepříznivých událostí koincidujících s hodnocenou léčbou. Celková bezpečnost. Účinnost: Hodnocení kvality hojení kostních defektů stehenní kosti pomoci Harrisonova kyčelního skóre, rentgenových snímků a denzitometriem srovnání s referenčními daty. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To participate in this trial, patients have to meet following criteria: 1. Established diagnosis of aseptic loosening of a total hip arthoplasty indicated for revision hip surgery; 2. Subjects with extensive femoral bone defects; 3. Age between 18-75 years, both sexes, and - for subjects aged 18 to 65 years: ASA score I to III - for subjects aged 66 to 75 years: ASA score I to II 4. Able to provide written informed consent
(ASA score: A physical status classification systém of the American Society of Anesthesiologist for assessing the fitnes of patients befor surgery) |
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E.4 | Principal exclusion criteria |
Patients meeting any of the following criteria shall not be allowed to principate in thos study: 1. Previous infection at the site of total hip arthroplasty 2. Rheumatoid arthritis 3. Pregnancy or breastfeeding 4. Women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contaceptive measures taken by their sexual partners 5. fertile men not using proven contraceptive measures including effective contraception method (established oral contraception, intrauterine device, ligation of the uterine tube) in their partner 6. skin infection at the site of bone marrow aspiration or at the site of total hip arthroplasty 7. malnutrition, primary biliar cirrhosis 8. any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, systemic infection, ...) 9. alcohol or drug abuse 10. cancer (compulsory clinical oncological screening) 11. osteonecrosis of pelvis and hip due to past radiation treatment 12. ongoing and recent (last 3 months) systemic corticosteroid or immunosuppressive therapy
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: Safety: To assess an absence of complications at the site of revision total hip arthroplasty. |
Primární koncový bod: Bezpečnost: Hodnocení nepřítomnosti komplikací v oblasti revizní totální endoprotézy kyčelního kloubu. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At each visit since Visit V (1 days post-surgery) until Visit X (12 months postsurgery). |
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E.5.2 | Secondary end point(s) |
To assess the quality of life measured by Harris Hip Score and the quality of healing measured by plain X-rays and densitometry 12 month after surgery. |
Hodnocení kvality života pomocí Harrisova kyčelního skóre a kvality hojení pomocí rentgenologického vyšetř |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At Visit X (12 months postsurgery) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Subjects scheduled for total hip endoprosthesis re-implantation and meeting inclusion/exclusion criteria will be assigned to autologous mesenchymal stromal cell (AMSC) treatment to heal femoral bone defects during the revision total hip arthroplasty. The subjects will be followed up for 1 year aftre the surgery and test product administration. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |