Total Hip Arthroplasty Clinical Trial
Official title:
A Phase I/II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).
One of the main problems when performing THA via the standard transgluteal approach is the
necessary injury of the gluteus medius muscle. The consecutive decrease of contractile
muscle substance and the substitution by scar tissue leads to functional deficits of the
pelvic-stabilizing musculature with an insufficiency limp in a large number of patients. In
the long run the lack of musculature leads to a decrease in bone substance at the insertion
sites of the gluteal muscles of the proximal femur. The present study has the aim of
establishing a new therapy for iatrogenic gluteal muscle damage. The hypothesis of the
present proposal is that intra-muscular (IM) injection of PLX-PAD into the iatrogenically
injured gluteus medius muscle after THA results in an improved regeneration of the skeletal
muscle tissue and consecutively in an improved functional outcome.
Subjects will be assigned to receive one of the two targeted doses of PLX-PAD or placebo. On
the treatment day, after suturing the gluteus medius muscle PLX-PAD or placebo will be
applied directly to the site of laceration.
Patients will be followed up for efficacy assessment up to week 26 and for safety assessment
(Adverse events, vital signs, ECG, routinf lab and immunological testing) up to week 52
after THA. Patients will be phoned at week 104 in order to inquire about the occurence of
new cancer.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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