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

NCT02417922 | Completed

• 1 other identifier: H-1-2010-052
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• ATRS (Achilles Tendon Total Rupture Score)

  Patient-reported validated scoring tool developed for assessment of symptoms and physical activity after treatment for acute achilles tendon rupture (score 0-100 points)

  After immobilization period (8 weeks) and again after 12 weeks, 24 weeks and 52 weeks from injury date

Secondary Outcomes (3)

• Isometric Strength test

  After 12 weeks, 24 weeks and 52 weeks from injury date

• Heel-rise test

  After 12 weeks, 24 weeks and 52 weeks from injury date

• Tendon elongation

  At baseline, after immobilization (8 weeks) and again after 12 weeks, 24 weeks and 52 weeks from injury date

Study Arms (2)

Autologous conditioned plasma (ACP)

EXPERIMENTAL

Whole blood was drawn from the patients using arthrex system (total of 10 mls whole blood). After that whole blood spinning is conducted for 5 minutes and ACP with platelets and growth factors is separated from the red and white blood cells (around 4 mls). ACP is injected at baseline, 2 weeks, 4 weeks and after 6 weeks from injury date.

Other: ACP

Saline

PLACEBO COMPARATOR

Saline (4 mls) is injected around the ruptured achilles tendon at baseline, 2 weeks, 4 weeks and after 6 weeks from injury date.

Other: Saline

Interventions

Saline OTHER

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

Saline

ACP OTHER

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

Autologous conditioned plasma (ACP)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25-60 years.
• The patient must be able to speak and understand Danish.
• The patient must be able to give informed consent.
• The patient should be able to follow the instructed regimen with a removable ankle orthosis.
• The patient must be able to determine when rupture occurred, and it can't be over 4 days old.
• The patient should be able to follow the postoperative controls.

You may not qualify if:

• Terminal illness.
• Former achilles tendon rupture
• Former surgery on the achilles tendon
• Treatment with fluoroquinolones during the last 6 months.
• Tendinosis treated with a tablet or injection with corticosteroids within the last 6 months.
• Diagnosis of arterial insufficient in the leg.
• Lack of palpable pulse in the foot
• Severe medical illness: ASA score greater than 2

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Institute of Sportsmedicine, Bispebjerg hospital

Copenhagen, Copenhagen, 2400, Denmark

Location

Related Publications (1)

• Boesen AP, Boesen MI, Hansen R, Barfod KW, Lenskjold A, Malliaras P, Langberg H. Effect of Platelet-Rich Plasma on Nonsurgically Treated Acute Achilles Tendon Ruptures: A Randomized, Double-Blinded Prospective Study. Am J Sports Med. 2020 Jul;48(9):2268-2276. doi: 10.1177/0363546520922541. Epub 2020 Jun 2.

  PMID: 32485112 DERIVED

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael Kjaer, Dr. Med.

  Institute of Sportsmedicine Copenhagen, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: April 16, 2015
• Study Start: February 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: November 1, 2014
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

DK (1)