An interventional study of Saline and ACP in Tendon Rupture, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to male participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-04-16.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Treatment
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.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's enrollment of 40 is below the median of 72 across 334 interventional studies indexed under Rupture.
Browse Rupture studies →Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 (4 mls) is injected around the ruptured achilles tendon at baseline, 2 weeks, 4 weeks and after 6 weeks from injury date.
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.
4 mls of ACP is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment.
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)
Time frame: After immobilization period (8 weeks) and again after 12 weeks, 24 weeks and 52 weeks from injury date
Isometric Strength test
The subjects were asked to produce an isometric contraction of the calf muscle with increasing force to their maximum voluntary effort (MVC) over a 10 sec period. The MVC was performed on both legs to measure the differences between the two legs.
Time frame: After 12 weeks, 24 weeks and 52 weeks from injury date
Heel-rise test
The accumulated work made doing repetitive heel-rises is measured on each leg to see the differences between the two legs.
Time frame: After 12 weeks, 24 weeks and 52 weeks from injury date
Tendon elongation
Tendon length was measured with ultrasound on both legs during intervention to see possible tendon elongation after achilles rupture. The landmarks for measure the tendon length was the proximal part of the top of the calcaneus bone and most distal part of the muscular-tendinous part of the m. gastrocnemius medial.
Time frame: At baseline, after immobilization (8 weeks) and again after 12 weeks, 24 weeks and 52 weeks from injury date
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bispebjerg Hospital