Autologous Platelet Rich Plasma Effect on Bone HealingPhase 4NCT03261843
The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion
A Phase 4 study testing autologous platelet rich plasma and posterior lumbar interbody fusion without autologous platelet rich plasma in people with Autologous Platelet Rich Plasma Effect on Bone Healing, run by Assiut University.
Trial summary
the study aims to determine the effect of using Autologous platelet rich plasma on both the quality \& rate of posterior lumbar interbody fusion \& its outcome on the Patient regarding postoperative lumbar pain \& functional outcome Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Autologous Platelet Rich Plasma Effect on Bone Healing
- What is being tested?
- autologous platelet rich plasma and posterior lumbar interbody fusion without autologous platelet rich plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 May 2019
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spondylolisthesis.
- Degenerative disc disease requiring posterior lumbar interbody fusion not responding to medical treatment for 1 year.
- Age between 20 \& 70 years.
- Single or multiple level fusions.
Who cannot join
- Previous lumbar spine surgery.
- Other lumbar spine pathology
- severe osteoporosis
- Chronic use of steroid or non-steroidal anti-inflammatory drugs (more than one year)
- Patients younger than 20 years old.
- Patients older than 70 years old.
- Immunocompromised patients (eg. Chronic renal failure)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion : a Randomized Comparative Trial
the study aims to determine the effect of using Autologous platelet rich plasma on both the quality \& rate of posterior lumbar interbody fusion \& its outcome on the Patient regarding postoperative lumbar pain \& functional outcome
Read the detailed description
The study will be submitted for approval by the Ethics Committee of Faculty of Medicine, Assiut University, and written informed consent will be obtained from all patients prior to enrollment. The study population will be selected from patients attending the Department of Orthopedics and Trauma surgery, Assiut University hospitals.
Sixty patients will be selected for the study and will be randomized into two group one receiving posterior lumbar interbody fusion with Autologous platelet rich plasma and the other group will receive posterior lumbar interbody fusion without Autologous platelet rich plasma.
Methodology pre-operative preparation: Prior to the operation the selected patients will perform lumbar spine Computarised tomography and X ray films. Both the visual analogue scale of pain and the Oswestry disability index will be collected from the patients
Autologous platelet rich plasma preparation:
Autologous Platelet rich plasma is obtained using a two-stage centrifugation process.
Whole blood sample will be drawn from the participant and be collected in a sterile tube containing anticoagulant (sodium citrate 3.8% or Ethylenediaminetetraacetic acid ). The tube will be centrifuged at 160xg relative centrifugal force (about 1000 round per minute) for 10 min in a centrifugal apparatus. The first spin will separate platelet poor plasma at the top from red blood cells at the bottom and platelet rich plasma above (mixed with the white blood cells in the buffy coat). The Platelet poor plasma, Platelet rich plasma and a few red blood cells will be aspirated into a new tube, mixed and in the second spin, the tube will be centrifuged at 400xg relative centrifugal form (about 1500 round per minute) for another 10 minutes. The upper section will consist of Platelet poor plasma and the Platelet rich plasma will be collected at the bottom of the tube in the form of pellet. Then, Platelet poor plasma and Platelet rich plasma will be aspirated and mixed (discarding the upper portion). Prior to treatment calcium chloride 3% will be added to activate platelets immediately before its application to avoid coagulation of the specimen (for every 1.5 milliliter plasma, 1 milliliter calcium chloride 3% is added).
Surgery:
A posterior lumbar interbody fusion with posterior pedicle screw fixation will be performed through a midline posterior approach. Trans-pedicular screws will be placed under fluoroscopic guidance, followed by discectomy. The vertebral body endplates will be prepared by curetting until point bleeding was seen.
Autologous cancellous bone chips will be harvested unilaterally from the iliac wing, approached through the midline posterior incision. The bone chips will be steeped in the plasma solution until clotting occurred visually (approximately 10 minutes). In the control group, the bone chips will be filled with autologous bone in the same way and were implanted after approximately 10 minutes without incubation in a plasma solution.
- Being tested
- autologous platelet rich plasma, posterior lumbar interbody fusion without autologous platelet rich plasma
- Keywords
- platelet rich plasma , posterior lumbar interbody fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous platelet rich plasmaBiological
adding autologous platelet rich plasma to the bone graft harvested from the patient
posterior lumbar interbody fusion without autologous platelet rich plasmaProcedure or surgery
performing posterior lumbar interbody fusion without using platelet rich plasma
| Study group | Role | What they receive |
|---|---|---|
| posterior lumbar interbody fusion + platelet rich plasma | Active comparator | the addition of autologous platelet rich plasma to the bone graft Receives: Biological: autologous platelet rich plasma |
| posterior lumbar interbody fusion | Active comparator | bone graft alone Receives: Procedure: posterior lumbar interbody fusion without autologous platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
bridging trabecular bone scale
the degree of bridging bone across the fused vertebral bodies
Measured: from 3 to 6 month post-operative
Secondary outcomes (2)
visual analogue of pain
the amount of pain sensed by the patient pre and post-operative
Measured: from 3 to 6 month post-operative
the Oswestry disability index
the functional outcome on the patient
Measured: from 3 to 6 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Autologous Platelet Rich Plasma Effect on Bone HealingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Model description
- single center, prospective randomized comparative trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelazim Abdelrahim Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261843
- Sponsor's protocol ID
- platelet rich plasma
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
PubMed 26831629Sys J, Weyler J, Van Der Zijden T, Parizel P, Michielsen J. Platelet-rich plasma in mono-segmental posterior lumbar interbody fusion. Eur Spine J. 2011 Oct;20(10):1650-7. doi: 10.1007/s00586-011-1897-0. Epub 2011 Jul 10.
PubMed 21744284Weiner BK, Walker M. Efficacy of autologous growth factors in lumbar intertransverse fusions. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1968-70; discussion 1971. doi: 10.1097/01.BRS.0000083141.02027.48.
PubMed 12973143Hee HT, Majd ME, Holt RT, Myers L. Do autologous growth factors enhance transforaminal lumbar interbody fusion? Eur Spine J. 2003 Aug;12(4):400-7. doi: 10.1007/s00586-003-0548-5. Epub 2003 May 22.
PubMed 12761669Kaux JF, Le Goff C, Seidel L, Peters P, Gothot A, Albert A, Crielaard JM. [Comparative study of five techniques of preparation of platelet-rich plasma]. Pathol Biol (Paris). 2011 Jun;59(3):157-60. doi: 10.1016/j.patbio.2009.04.007. Epub 2009 May 28. French.
PubMed 19481375Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
PubMed 15085519Ferrari M, Zia S, Valbonesi M, Henriquet F, Venere G, Spagnolo S, Grasso MA, Panzani I. A new technique for hemodilution, preparation of autologous platelet-rich plasma and intraoperative blood salvage in cardiac surgery. Int J Artif Organs. 1987 Jan;10(1):47-50.
PubMed 3570542
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion : a Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT03261843
- Acronym / sponsor ID
- platelet rich plasma
- Keywords
- platelet rich plasma , posterior lumbar interbody fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 25 Aug 2017 (actual)
- 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 study aims to determine the effect of using Autologous platelet rich plasma on both the quality \& rate of posterior lumbar interbody fusion \& its outcome on the Patient regarding postoperative lumbar pain \& functional outcome
Detailed description
The study will be submitted for approval by the Ethics Committee of Faculty of Medicine, Assiut University, and written informed consent will be obtained from all patients prior to enrollment. The study population will be selected from patients attending the Department of Orthopedics and Trauma surgery, Assiut University hospitals.
Sixty patients will be selected for the study and will be randomized into two group one receiving posterior lumbar interbody fusion with Autologous platelet rich plasma and the other group will receive posterior lumbar interbody fusion without Autologous platelet rich plasma.
Methodology pre-operative preparation: Prior to the operation the selected patients will perform lumbar spine Computarised tomography and X ray films. Both the visual analogue scale of pain and the Oswestry disability index will be collected from the patients
Autologous platelet rich plasma preparation:
Autologous Platelet rich plasma is obtained using a two-stage centrifugation process.
Whole blood sample will be drawn from the participant and be collected in a sterile tube containing anticoagulant (sodium citrate 3.8% or Ethylenediaminetetraacetic acid ). The tube will be centrifuged at 160xg relative centrifugal force (about 1000 round per minute) for 10 min in a centrifugal apparatus. The first spin will separate platelet poor plasma at the top from red blood cells at the bottom and platelet rich plasma above (mixed with the white blood cells in the buffy coat). The Platelet poor plasma, Platelet rich plasma and a few red blood cells will be aspirated into a new tube, mixed and in the second spin, the tube will be centrifuged at 400xg relative centrifugal form (about 1500 round per minute) for another 10 minutes. The upper section will consist of Platelet poor plasma and the Platelet rich plasma will be collected at the bottom of the tube in the form of pellet. Then, Platelet poor plasma and Platelet rich plasma will be aspirated and mixed (discarding the upper portion). Prior to treatment calcium chloride 3% will be added to activate platelets immediately before its application to avoid coagulation of the specimen (for every 1.5 milliliter plasma, 1 milliliter calcium chloride 3% is added).
Surgery:
A posterior lumbar interbody fusion with posterior pedicle screw fixation will be performed through a midline posterior approach. Trans-pedicular screws will be placed under fluoroscopic guidance, followed by discectomy. The vertebral body endplates will be prepared by curetting until point bleeding was seen.
Autologous cancellous bone chips will be harvested unilaterally from the iliac wing, approached through the midline posterior incision. The bone chips will be steeped in the plasma solution until clotting occurred visually (approximately 10 minutes). In the control group, the bone chips will be filled with autologous bone in the same way and were implanted after approximately 10 minutes without incubation in a plasma solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single center, prospective randomized comparative trial
| Arm | Type | Receives |
|---|---|---|
| posterior lumbar interbody fusion + platelet rich plasma | Active comparator | Biological: autologous platelet rich plasmathe addition of autologous platelet rich plasma to the bone graft |
| posterior lumbar interbody fusion | Active comparator | Procedure: posterior lumbar interbody fusion without autologous platelet rich plasmabone graft alone |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spondylolisthesis.
- Degenerative disc disease requiring posterior lumbar interbody fusion not responding to medical treatment for 1 year.
- Age between 20 \& 70 years.
- Single or multiple level fusions.
Key exclusion criteria (7 listed)
- Previous lumbar spine surgery.
- Other lumbar spine pathology
- severe osteoporosis
- Chronic use of steroid or non-steroidal anti-inflammatory drugs (more than one year)
- Patients younger than 20 years old.
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 |
|---|---|---|
| autologous platelet rich plasmaadding autologous platelet rich plasma to the bone graft harvested from the patient | Biological | posterior lumbar interbody fusion + platelet rich plasma |
| posterior lumbar interbody fusion without autologous platelet rich plasmaperforming posterior lumbar interbody fusion without using platelet rich plasma | Procedure or surgery | posterior lumbar interbody fusion |
Primary outcome
bridging trabecular bone scale
Time frame: from 3 to 6 month post-operative
the degree of bridging bone across the fused vertebral bodies
2 secondary outcomes
visual analogue of pain
Time frame: from 3 to 6 month post-operative
the Oswestry disability index
Time frame: from 3 to 6 month post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Results publication: PubMed 26831629Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
- Results publication: PubMed 21744284Sys J, Weyler J, Van Der Zijden T, Parizel P, Michielsen J. Platelet-rich plasma in mono-segmental posterior lumbar interbody fusion. Eur Spine J. 2011 Oct;20(10):1650-7. doi: 10.1007/s00586-011-1897-0. Epub 2011 Jul 10.
- Results publication: PubMed 12973143Weiner BK, Walker M. Efficacy of autologous growth factors in lumbar intertransverse fusions. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1968-70; discussion 1971. doi: 10.1097/01.BRS.0000083141.02027.48.
- Results publication: PubMed 12761669Hee HT, Majd ME, Holt RT, Myers L. Do autologous growth factors enhance transforaminal lumbar interbody fusion? Eur Spine J. 2003 Aug;12(4):400-7. doi: 10.1007/s00586-003-0548-5. Epub 2003 May 22.
- Results publication: PubMed 19481375Kaux JF, Le Goff C, Seidel L, Peters P, Gothot A, Albert A, Crielaard JM. [Comparative study of five techniques of preparation of platelet-rich plasma]. Pathol Biol (Paris). 2011 Jun;59(3):157-60. doi: 10.1016/j.patbio.2009.04.007. Epub 2009 May 28. French.
- Results publication: PubMed 15085519Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
- Results publication: PubMed 3570542Ferrari M, Zia S, Valbonesi M, Henriquet F, Venere G, Spagnolo S, Grasso MA, Panzani I. A new technique for hemodilution, preparation of autologous platelet-rich plasma and intraoperative blood salvage in cardiac surgery. Int J Artif Organs. 1987 Jan;10(1):47-50.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing autologous platelet rich plasma and posterior lumbar interbody fusion without autologous platelet rich plasma in people with Autologous Platelet Rich Plasma Effect on Bone Healing, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 25 Aug 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A A Hassan, M.B.B.ch (+201288103657, ahmedabdelazim2014@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bridging trabecular bone scale (time frame: from 3 to 6 month post-operative). 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 NCT03261843, which also lists 7 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 25 Aug 2017.