Knee InstabilityPhase 4NCT01111747
Patellar Tendon Regeneration With Platelet-rich Plasma
A Phase 4 study testing Platelet-rich plasma in people with Knee Instability, run by University of Sao Paulo General Hospital.
Trial summary
The central third of the patellar tendon is used as a donor site for anterior cruciate ligament (ACL) reconstruction. After months or years the harvest site partially regenerates. The regeneration process is accomplished by biological mechanisms,including cells and proteins known as growth factors. Read more about this study
- Who is it for?
- Ages Up to 45 years
- Conditions the study is for
- Knee Instability
- What is being tested?
- Platelet-rich plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Dec 2010
- Phase
- Phase 4
- 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 Up to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- indication of anterior cruciate ligament surgery with patellar ligament
- skeletal maturity
Who cannot join
- other knee ligament injuries
- severe chondral lesions
- osteoarthritis
- non-compliance to the rehabilitation
- previous surgery in the affected knee
- reoperation during the time of the study for an unrelated condition
- infection
About this study
Official title: Regeneration of the Patellar Tendon After Harvesting Its Central Third With Platelet-rich Plasma. Prospective and Randomized Study.
The central third of the patellar tendon is used as a donor site for anterior cruciate ligament (ACL) reconstruction. After months or years the harvest site partially regenerates. The regeneration process is accomplished by biological mechanisms,including cells and proteins known as growth factors. The platelets are natural reservoirs of growth factors, and a platelet concentrate known as Platelet-Rich Plasma (PRP) has a three to five fold increase in growth factors. The hypothesis of the study is that the PRP can improve the regeneration of the patellar tendon.
The platelets are obtained from the patient's blood through a filtration system called apheresis, with the use of 250 milliliters of blood, with a sterile system. All the others components of blood (red cells, plasma, white cells) returns to the patient. The PRP is then applied in the harvest site on the patellar tendon, at the end of ACL reconstruction.
The patients are randomized in two groups, one with the use of PRP and the other group without PRP. This information for the patients will be granted just at the end of the research. After the surgery the rehabilitation protocol is the same for both groups. An isokinetic testing is done before the surgery and after six months. Questionnaires about the knee function are asked before the surgery and after six months. A magnetic resonance imaging is performed after six months to evaluate the tendon regeneration.
- Conditions
- Knee Instability
- Being tested
- Platelet-rich plasma, Control group
- Keywords
- platelet-rich plasma, patellar ligament, regeneration, growth substances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaProcedure or surgery
Also called PRP, platelet gel, platelet concentrate, growth factors concentrate
Intra-operative use of platelet-rich plasma in the patellar tendon after harvesting its central third for ACL reconstruction.
Control groupProcedure or surgery
Also called PRP, platelet-rich plasma, platelet gel, platelet concentrate
In this group PRP will not be added to the patellar tendon donor site at the end of ACL reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| PRP | Experimental | In this group PRP will be used in the patellar tendon donor site. Receives: Procedure: Platelet-rich plasma |
| Control | Sham comparator | In this group PRP will not be aded to the patellar tendon donor site Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the patellar tendon regeneration with magnetic resonance imaging.
Six months after the surgery a magnetic resonance imaging will be done to evaluate the regeneration of the patellar tendon donor site. The area of the gap, related to the tendon harvest, will be measured and compared between the groups.
Measured: Six months
Secondary outcomes (1)
Isokinetic testing and questionaires.
Six months after the surgery, patients will answer to questionaires about their knee function and do an isokinetic testing to evaluate their muscle strength. The results will be compared between the groups.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startNov 2008
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Knee InstabilityStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
- Responsible party
- Sponsor
- Investigators
- Adriano M Almeida, MD, Principal investigator, Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, BrazilArnaldo J Hernandez, MD, PhD, Study director, Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111747
- Sponsor's protocol ID
- 0162/08
- Other IDs
- CaPPesqHCFMUSP 0162/2008
- Status last verified
- Apr 2010
- First submitted
- 26 Apr 2010
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kartus J, Movin T, Papadogiannakis N, Christensen LR, Lindahl S, Karlsson J. A radiographic and histologic evaluation of the patellar tendon after harvesting its central third. Am J Sports Med. 2000 Mar-Apr;28(2):218-26. doi: 10.1177/03635465000280021301.
PubMed 10750999Meisterling RC, Wadsworth T, Ardill R, Griffiths H, Lane-Larsen CL. Morphologic changes in the human patellar tendon after bone-tendon-bone anterior cruciate ligament reconstruction. Clin Orthop Relat Res. 1993 Apr;(289):208-12.
PubMed 8472418Svensson M, Kartus J, Ejerhed L, Lindahl S, Karlsson J. Does the patellar tendon normalize after harvesting its central third?: a prospective long-term MRI study. Am J Sports Med. 2004 Jan-Feb;32(1):34-8. doi: 10.1177/0363546503258935.
PubMed 14754721Anaguchi Y, Yasuda K, Majima T, Tohyama H, Minami A, Hayashi K. The effect of transforming growth factor-beta on mechanical properties of the fibrous tissue regenerated in the patellar tendon after resecting the central portion. Clin Biomech (Bristol). 2005 Nov;20(9):959-65. doi: 10.1016/j.clinbiomech.2005.05.012.
PubMed 16055249Anitua E, Andia I, Ardanza B, Nurden P, Nurden AT. Autologous platelets as a source of proteins for healing and tissue regeneration. Thromb Haemost. 2004 Jan;91(1):4-15. doi: 10.1160/TH03-07-0440.
PubMed 14691563Spindler KP, Nanney LB, Davidson JM. Proliferative responses to platelet-derived growth factor in young and old rat patellar tendon. Connect Tissue Res. 1995;31(2):171-7. doi: 10.3109/03008209509028405.
PubMed 15612333Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.
PubMed 12696985Aspenberg P. Stimulation of tendon repair: mechanical loading, GDFs and platelets. A mini-review. Int Orthop. 2007 Dec;31(6):783-9. doi: 10.1007/s00264-007-0398-6. Epub 2007 Jun 22.
PubMed 17583812Rodeo SA, Potter HG, Kawamura S, Turner AS, Kim HJ, Atkinson BL. Biologic augmentation of rotator cuff tendon-healing with use of a mixture of osteoinductive growth factors. J Bone Joint Surg Am. 2007 Nov;89(11):2485-97. doi: 10.2106/JBJS.C.01627.
PubMed 17974893Sanchez M, Anitua E, Azofra J, Andia I, Padilla S, Mujika I. Comparison of surgically repaired Achilles tendon tears using platelet-rich fibrin matrices. Am J Sports Med. 2007 Feb;35(2):245-51. doi: 10.1177/0363546506294078. Epub 2006 Nov 12.
PubMed 17099241
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regeneration of the Patellar Tendon After Harvesting Its Central Third With Platelet-rich Plasma. Prospective and Randomized Study.
- ClinicalTrials.gov ID
- NCT01111747
- Acronym / sponsor ID
- 0162/08
- Conditions
- Knee Instability
- Keywords
- platelet-rich plasma, patellar ligament, regeneration, growth substances
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
- Study start
- Nov 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Apr 2010 (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 central third of the patellar tendon is used as a donor site for anterior cruciate ligament (ACL) reconstruction. After months or years the harvest site partially regenerates. The regeneration process is accomplished by biological mechanisms,including cells and proteins known as growth factors. The platelets are natural reservoirs of growth factors, and a platelet concentrate known as Platelet-Rich Plasma (PRP) has a three to five fold increase in growth factors. The hypothesis of the study is that the PRP can improve the regeneration of the patellar tendon.
The platelets are obtained from the patient's blood through a filtration system called apheresis, with the use of 250 milliliters of blood, with a sterile system. All the others components of blood (red cells, plasma, white cells) returns to the patient. The PRP is then applied in the harvest site on the patellar tendon, at the end of ACL reconstruction.
The patients are randomized in two groups, one with the use of PRP and the other group without PRP. This information for the patients will be granted just at the end of the research. After the surgery the rehabilitation protocol is the same for both groups. An isokinetic testing is done before the surgery and after six months. Questionnaires about the knee function are asked before the surgery and after six months. A magnetic resonance imaging is performed after six months to evaluate the tendon regeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Procedure: Platelet-rich plasmaIn this group PRP will be used in the patellar tendon donor site. |
| Control | Sham comparator | Procedure: Control groupIn this group PRP will not be aded to the patellar tendon donor site |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- indication of anterior cruciate ligament surgery with patellar ligament
- skeletal maturity
Key exclusion criteria (7 listed)
- other knee ligament injuries
- severe chondral lesions
- osteoarthritis
- non-compliance to the rehabilitation
- previous surgery in the affected knee
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 |
|---|---|---|
| Platelet-rich plasmaAlso: PRP, platelet gel, platelet concentrate, growth factors concentrateIntra-operative use of platelet-rich plasma in the patellar tendon after harvesting its central third for ACL reconstruction. | Procedure or surgery | PRP |
| Control groupAlso: PRP, platelet-rich plasma, platelet gel, platelet concentrateIn this group PRP will not be added to the patellar tendon donor site at the end of ACL reconstruction. | Procedure or surgery | Control |
Primary outcome
Evaluation of the patellar tendon regeneration with magnetic resonance imaging.
Time frame: Six months
Six months after the surgery a magnetic resonance imaging will be done to evaluate the regeneration of the patellar tendon donor site. The area of the gap, related to the tendon harvest, will be measured and compared between the groups.
1 secondary outcome
Isokinetic testing and questionaires.
Time frame: Six months
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 14 Mar 2012.
- Background: PubMed 10750999Kartus J, Movin T, Papadogiannakis N, Christensen LR, Lindahl S, Karlsson J. A radiographic and histologic evaluation of the patellar tendon after harvesting its central third. Am J Sports Med. 2000 Mar-Apr;28(2):218-26. doi: 10.1177/03635465000280021301.
- Background: PubMed 8472418Meisterling RC, Wadsworth T, Ardill R, Griffiths H, Lane-Larsen CL. Morphologic changes in the human patellar tendon after bone-tendon-bone anterior cruciate ligament reconstruction. Clin Orthop Relat Res. 1993 Apr;(289):208-12.
- Background: PubMed 14754721Svensson M, Kartus J, Ejerhed L, Lindahl S, Karlsson J. Does the patellar tendon normalize after harvesting its central third?: a prospective long-term MRI study. Am J Sports Med. 2004 Jan-Feb;32(1):34-8. doi: 10.1177/0363546503258935.
- Background: PubMed 16055249Anaguchi Y, Yasuda K, Majima T, Tohyama H, Minami A, Hayashi K. The effect of transforming growth factor-beta on mechanical properties of the fibrous tissue regenerated in the patellar tendon after resecting the central portion. Clin Biomech (Bristol). 2005 Nov;20(9):959-65. doi: 10.1016/j.clinbiomech.2005.05.012.
- Background: PubMed 14691563Anitua E, Andia I, Ardanza B, Nurden P, Nurden AT. Autologous platelets as a source of proteins for healing and tissue regeneration. Thromb Haemost. 2004 Jan;91(1):4-15. doi: 10.1160/TH03-07-0440.
- Background: PubMed 15612333Spindler KP, Nanney LB, Davidson JM. Proliferative responses to platelet-derived growth factor in young and old rat patellar tendon. Connect Tissue Res. 1995;31(2):171-7. doi: 10.3109/03008209509028405.
- Background: PubMed 12696985Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.
- Background: PubMed 17583812Aspenberg P. Stimulation of tendon repair: mechanical loading, GDFs and platelets. A mini-review. Int Orthop. 2007 Dec;31(6):783-9. doi: 10.1007/s00264-007-0398-6. Epub 2007 Jun 22.
- Background: PubMed 17974893Rodeo SA, Potter HG, Kawamura S, Turner AS, Kim HJ, Atkinson BL. Biologic augmentation of rotator cuff tendon-healing with use of a mixture of osteoinductive growth factors. J Bone Joint Surg Am. 2007 Nov;89(11):2485-97. doi: 10.2106/JBJS.C.01627.
- Background: PubMed 17099241Sanchez M, Anitua E, Azofra J, Andia I, Padilla S, Mujika I. Comparison of surgically repaired Achilles tendon tears using platelet-rich fibrin matrices. Am J Sports Med. 2007 Feb;35(2):245-51. doi: 10.1177/0363546506294078. Epub 2006 Nov 12.
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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.
Adriano M Almeida, MD principal investigator
Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
Arnaldo J Hernandez, MD, PhD study director
Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet-rich plasma in people with Knee Instability, run by University of Sao Paulo General Hospital.
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 2 inclusion and 7 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 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of the patellar tendon regeneration with magnetic resonance imaging. (time frame: Six months). 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 NCT01111747, which also lists 10 linked publications.
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 14 Mar 2012.