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Clinical Trials/RPCEC00000250
RPCEC00000250
Completed
Phase 1

Evaluation of the intra-articular application of a bioactive formulation for the treatment of osteoarthritis: Clinical Trial Phase I-II - ARTROTX

Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico0 sites50 target enrollmentAugust 15, 2017
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ConditionsOsteoarthritis of the knee, hip, shoulder, or jaw jointsOsteoarthritis of the JawOsteoarthritis of the shoulderOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritis, HipOsteoarthritis, Knee

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Osteoarthritis of the knee, hip, shoulder, or jaw joints
Sponsor
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
Enrollment
50
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 15, 2017
End Date
January 31, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients older than 18 years.
  • •2\. Patients with clinical and radiographic diagnosis of osteoarthritis in the hip, knee, shoulder or mandible.
  • •3\. Patients with severe structural damage to their joint.
  • •4\. Severe and unproven articular symptomatology to conservative treatment and candidates for total joint arthroplasty (joint prosthesis placement).
  • •5\. Signature written informed consent of the patient

Exclusion Criteria

  • •1\. Rheumatoid arthritis
  • •2\. Autoimmune diseases
  • •3\. Decompensated systemic disease
  • •4\. Creatinine 1\.25 times the normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method).
  • •5\. Blood leucocytes less than 3000 cells / microliter or platelet count less than 100,000 / microliter.
  • •6\. Blood hemoglobin less than 10 g / deciliter.
  • •7\. Increase in the last month of diastolic blood pressure to 110 mmHg or more and / or onset of hematuria or proteinuria greater than 300 milligrams / day.
  • •9\. Pregnancy or women of childbearing potential without contraceptive method: salpingoclasia, device or hormonal. Breastfeeding women.
  • •10\. Alcoholism and / or drug addiction.
  • •11\. Known liver disease with twice the increase in liver function tests (Aspartate amino transferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin).

Outcomes

Primary Outcomes

Not specified

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