MedTrace Logo

Effect of Autologous Conditioned Plasma Treatment for Conservative Treated Total Achilles Tendon Tears

NCT02417922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-04-16

No results posted yet for this study

Summary

The purpose is to see if Autologous Conditioned Plasma (ACP) promote and accelerating tendon tissue healing in Conservative treated total Achilles Tendon Tears.

40 healthy males were randomized to either receive ACP or Placebo (saline) around the ruptured achilles tendon at baseline, 2 weeks, 4 weeks and again after 6 weeks during the 8 weeks immobilization period with an orthosis. Ultrasound and symptoms scores (ATLS) was performed at baseline, after 8 weeks immobilization and again after 3 month, 6 month and 12 month. Scoring and functional tests was performed after the 8 weeks immobilization and again after 12 weeks, 24 weeks and 52 weeks from injury date.

Conditions

  • Tendon Rupture

Interventions

OTHER

Saline

4 mls of saline is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment.

OTHER

ACP

4 mls of ACP is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment.

Sponsors & Collaborators

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Michael Kjaer, Dr. Med. · Institute of Sportsmedicine Copenhagen, Bispebjerg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-12-31
Completion
2014-11-30

Countries

  • Denmark

Study Locations

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 NCT02417922 on ClinicalTrials.gov