MedTrace Logo

Regenerative Injection Therapy and Osteoarthritis

NCT01206634 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2010-09-22

No results posted yet for this study

Summary

The objective is to assess the effectiveness of regenerative injection therapy (RIT) to relieve pain and restore function in patients with knee osteoarthritis.

The study design is a randomized controlled trial with cross-over. 40 patients with chronic knee osteoarthritis will be randomly assigned to receive exercise therapy for 32 weeks in combination with RIT on weeks 0, 4, 8, and 12 or exercise therapy for 32 weeks combined to RIT on weeks 20, 24, 28 and 32. The primary outcome is the WOMAC score.

Conditions

  • Knee Arthrosis

Interventions

PROCEDURE

Regenerative injection therapy

Injections of 1cc of a 15% dextrose and 0.6% lidocaine solution free of adrenaline in each of eight administration sites in the collateral ligaments and a 5 cc injection of a 20% dextrose and 0.5% lidocaine without adrenaline solution inside the knee joint.

BEHAVIORAL

Exercise

the exercise program consists of 4 strengthening exercises for which participants are asked to perform 3 sets of 10 repetitions daily

Sponsors & Collaborators

  • Réseau de Santé Vitalité Health Network

    lead OTHER

Principal Investigators

  • Richard Dumais, MD · Dr. Georges-L.-Dumont Regional Hospital, Vitalité Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-10-31
Completion
2008-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206634 on ClinicalTrials.gov