Tendon RuptureNCT02417922
Effect of Autologous Conditioned Plasma Treatment for Conservative Treated Total Achilles Tendon Tears
A study testing Saline and ACP in people with Tendon Rupture, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Tendon Rupture
- What is being tested?
- Saline and ACP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sportsmedicine, Bispebjerg hospital
Copenhagen, Copenhagen, 2400
About this study
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.
Read the 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
- Being tested
- Saline, ACP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineOther
4 mls of saline is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment.
ACPOther
4 mls of ACP is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: After immobilization period (8 weeks) and again after 12 weeks, 24 weeks and 52 weeks from injury date
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At baseline, after immobilization (8 weeks) and again after 12 weeks, 24 weeks and 52 weeks from injury date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Ploug Boesen, Bispebjerg Hospital
- Investigators
- Michael Kjaer, Dr. Med., Principal investigator, Institute of Sportsmedicine Copenhagen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417922
- Sponsor's protocol ID
- H-1-2010-052
- Status last verified
- Apr 2015
- First submitted
- 8 Dec 2011
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32485112
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Autologous Conditioned Plasma Treatment for Conservative Treated Total Achilles Tendon Tears: Randomized Double Blinded Placebo Control Trial
- ClinicalTrials.gov ID
- NCT02417922
- Acronym / sponsor ID
- H-1-2010-052
- Conditions
- Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous conditioned plasma (ACP) | Experimental | Other: ACPWhole 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. |
| Saline | Placebo comparator | Other: SalineSaline (4 mls) is injected around the ruptured achilles tendon at baseline, 2 weeks, 4 weeks and after 6 weeks from injury date. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline4 mls of saline is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment. | Other | Saline |
| ACP4 mls of ACP is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment. | Other | Autologous conditioned plasma (ACP) |
Primary outcome
ATRS (Achilles Tendon Total Rupture Score)
Time frame: After immobilization period (8 weeks) and again after 12 weeks, 24 weeks and 52 weeks from injury date
Patient-reported validated scoring tool developed for assessment of symptoms and physical activity after treatment for acute achilles tendon rupture (score 0-100 points)
3 secondary outcomes
Isometric Strength test
Time frame: After 12 weeks, 24 weeks and 52 weeks from injury date
Heel-rise test
Time frame: After 12 weeks, 24 weeks and 52 weeks from injury date
Tendon elongation
Time frame: At baseline, after immobilization (8 weeks) and again after 12 weeks, 24 weeks and 52 weeks from injury date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
- Derived from this study: PubMed 32485112Boesen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kjaer, Dr. Med. principal investigator
Institute of Sportsmedicine Copenhagen, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline and ACP in people with Tendon Rupture, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ATRS (Achilles Tendon Total Rupture Score) (time frame: After immobilization period (8 weeks) and again after 12 weeks, 24 weeks and 52 weeks from injury date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.