Effect of Autologous Conditioned Plasma Treatment for Conservative Treated Total Achilles Tendon Tears
Condition: Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

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.
    

Intervention name(s): Saline; ACP
Intervention type(s): Other; Other
Intervention description(s): 4 mls of saline is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment.; 4 mls of ACP is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment