Tendon Rupture Clinical Trial
Official title:
The Effect of Autologous Conditioned Plasma Treatment for Conservative Treated Total Achilles Tendon Tears: Randomized Double Blinded Placebo Control Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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