Conditions: Edematous Synovitis Foreign Body Reaction Osteolysis
Keywords: total joint arthroplasty synovitis ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion) osteolysis periprosthetic metallosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 57
Healthy volunteers: yes

Brief summary:
This research study is being conducted to determine if taking oral (by mouth in pill form) Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and improve function of non-infected symptomatic postoperative total joint replacements.

Detailed description:
To perform a prospective, randomized, double-blind clinical trial to determine if oral Apatone®B, an amalgam of vitamins C and K3, has a therapeutic efficacy beyond the conservative care customarily used to reduce inflammatory synovitis and to increase the functional capacity of proven non-infected symptomatic postoperative total joint replacements.

Arms:
arm 1: An amalgam of Vitamins C \& K3 arm 2: Oral capsule of similar appearance and taste without Apatone®B

Interventions: intervention 1: Placebo intervention 2: Apatone®B
Intervention descriptions: intervention 1: Two capsules taken twice daily with meals intervention 2: Two capsules taken twice daily with meals

Protocol document: