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

NCT ID: NCT02417922

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-11-30

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.

Detailed Description

Total achilles rupture is a severe injury and many has long lasting functional deficit afterwards. Treatment options is either operative or conservative treatment. Conservative treatment for total Achilles rupture has become more and more popular during the last 10 years. Nevertheless we still see a higher risk of re-rupture compared to surgery.

Aim: The aim of the study is in patients with acute total Achilles tendon rupture to examine if Autologous Conditioned Plasma (ACP) promote and accelerate tendon tissue healing in Conservative treated total Achilles tendon rupture and thereby gives a better functional outcome.

Materials and methods: Healthy males (25-60 years; n=40) with acute total achilles tendon ruptures is randomly assigned to either 1) ACP (~ 4 mls) or 2) placebo (saline ~ 4 mls) treatment. Participants will be treated on 4 successive occasions with 2 weeks (wks) interval during the 8 week conservative treatment with an orthoses. The injections will be performed under ultrasound guidance. All subjects will undergo a 8 weeks immobilization period with an orthoses with full weigh bearing and after that they will be guided in a proper rehabilitation regime during the intervention. Clinical effects will be assessed as changes in functional scoring system (ATLS), isometric muscle strength and muscle function (one-legged heel-rise test). Furthermore tendon length will be measured by ultrasound. All outcome measures will be recorded at baseline and again after 8 weeks immobilization (expect muscle strength and function), 12 weeks, 24 weeks and 52 weeks after injury.

Results: Look at possible changes and differences between groups (ACP and Placebo) in ATLS scores, muscle strength, ultrasound tendon length elongation and muscle function.

Statistics: All data will be analyzed in SigmaPlot v11 using two-way repeated measures ANOVA with Student-Newman-Keuls Post-hoc test. This is used to see changes over time in all groups (time effect) and differences between groups within time-points (group effect). All data will be presented as mean ± SEM time.

Conditions

Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Autologous conditioned plasma (ACP)

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.

Group Type: EXPERIMENTAL

ACP

Intervention Type: OTHER

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

Saline

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

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

Interventions

Saline

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anders Ploug Boesen

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Kjaer, Dr. Med.

Role: PRINCIPAL_INVESTIGATOR

Institute of Sportsmedicine Copenhagen, Bispebjerg Hospital

Locations

Institute of Sportsmedicine, Bispebjerg hospital

Copenhagen, Copenhagen, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 32485112 (View on PubMed)

Other Identifiers

H-1-2010-052

Identifier Type: -

Identifier Source: org_study_id