Platelet-Rich PlasmaPhase 4NCT03779945
Effect of Platelet-Rich-Plasma in Spine Fusion
A Phase 4 study testing autologous platelet rich plasma and posteriolateral lumbar fusion only in people with Platelet-Rich Plasma, run by Assiut University.
Trial summary
The objective of this study is to evaluate the fusion rate after the use of platelet rich plasma with autolgus bone graft and comparing it with bone graft alone Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Platelet-Rich Plasma
- What is being tested?
- autologous platelet rich plasma and posteriolateral lumbar fusion only
- 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
- 20 Dec 2018to 20 Jan 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- degenerative or lytic Spondylolisthesis.
- Degenerative disc disease requiring posterior lumbar fusion not responding to medical treatment for 1 year.
- Age between 20 \& 75 years.
- Single level fusion
Who cannot join
- Multiple levels patient Traumatic Spondylolisthesis Previous lumbar spine surgery. Other lumbar spine pathology severe osteoporosis Patients younger than 20 years old. Patients older than 75 years old. Immunocompromised patients (eg. Chronic renal failure)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Application of Platelet-Rich-Plasma in Posterolateral Lumbar Fusion
The objective of this study is to evaluate the fusion rate after the use of platelet rich plasma with autolgus bone graft and comparing it with bone graft alone
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.
A total of 104 patients treated with single level degenerative or lytic lumbar Spondylolisthesis indicated for PLF will be included ,patients will be classified into 2 groups Group A:Of 52 patients PLF + autologus bone graft+ PRP Group B: Of 52 patients treated with PLF + autologus bone graft only without adding PRP
Methods of evaluation
- History taking.
- Full clinical and neurological examination
- Radiological evaluation by x-ray (antero posterior, lateral, and, CT scans provide excellent views of bony detail) and MRI if needed Method of randomization By shuffling cards method the candidate patient will choose one card from104 cards 52 of them containing fusion with PRP and the other 52 contaning Fusion without PRP
Platelet-rich plasma (PRP 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 Ethylenediaminetetra acetic 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 specimen
- Conditions
- Platelet-Rich Plasma
- Being tested
- autologous platelet rich plasma, posteriolateral lumbar fusion only
- Keywords
- PRP
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
posteriolateral lumbar fusion onlyProcedure or surgery
performing posteriolateral lumbar fusion without using platelet rich plasma
| Study group | Role | What they receive |
|---|---|---|
| posteriolateral lumbar fusion +bone graft+ PRP | Active comparator | the addition of autologous platelet rich plasma to the bone graft Receives: Biological: autologous platelet rich plasma |
| posteriolateral lumbar fusion+bone graft only | Active comparator | posteriolateral lumbar fusion with adding autologus bone graft alone posteriolateral lumbar fusion only Receives: Procedure: posteriolateral lumbar fusion only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lenke classification of posterolateral fusion success
the degree of bridging bone across the fused vertebral bodies by using xray and CT scan
Measured: 6 month to1 year post-operative
Secondary outcomes (2)
modified Oswestry disability index ,
the functional outcome on the patient
Measured: 6 month to 1 year post-operative
visual analogue scale
the amount of pain sensed by the patient pre and post-operative
Measured: 6 month to 1 year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Dec 2018 (estimated)
- Primary completion20 Dec 2019 (estimated)
- Study completion20 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Platelet-Rich PlasmaStudies 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, Micheal Bassem Elia, Assiut University
- Investigators
- El Moataz A Zohny El Sabrout, professor, Study chair, Assiut UniversityEssam M Abdelmoneim Elmorshedy, Lecturer, Principal investigator, Assiut University. Belal O Mohamed Elnady, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779945
- Sponsor's protocol ID
- PRP in lumbar fusion
- Status last verified
- Dec 2018
- First submitted
- 17 May 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kubota G, Kamoda H, Orita S, Yamauchi K, Sakuma Y, Oikawa Y, Inage K, Sainoh T, Sato J, Ito M, Yamashita M, Nakamura J, Suzuki T, Takahashi K, Ohtori S. Platelet-rich plasma enhances bone union in posterolateral lumbar fusion: A prospective randomized controlled trial. Spine J. 2019 Feb;19(2):e34-e40. doi: 10.1016/j.spinee.2017.07.167. Epub 2017 Jul 20.
PubMed 28735763Shiga Y, Orita S, Kubota G, Kamoda H, Yamashita M, Matsuura Y, Yamauchi K, Eguchi Y, Suzuki M, Inage K, Sainoh T, Sato J, Fujimoto K, Abe K, Kanamoto H, Inoue M, Kinoshita H, Aoki Y, Toyone T, Furuya T, Koda M, Takahashi K, Ohtori S. Freeze-Dried Platelet-Rich Plasma Accelerates Bone Union with Adequate Rigidity in Posterolateral Lumbar Fusion Surgery Model in Rats. Sci Rep. 2016 Nov 11;6:36715. doi: 10.1038/srep36715.
PubMed 27833116Imagama S, Ando K, Kobayashi K, Ishikawa Y, Nakamura H, Hida T, Ito K, Tsushima M, Matsumoto A, Morozumi M, Tanaka S, Machino M, Ota K, Nakashima H, Takamatsu J, Matsushita T, Nishida Y, Ishiguro N, Matsuyama Y. Efficacy of Early Fusion With Local Bone Graft and Platelet-Rich Plasma in Lumbar Spinal Fusion Surgery Followed Over 10 Years. Global Spine J. 2017 Dec;7(8):749-755. doi: 10.1177/2192568217696690. Epub 2017 Apr 11.
PubMed 29238638Tarantino R, Donnarumma P, Mancarella C, Rullo M, Ferrazza G, Barrella G, Martini S, Delfini R. Posterolateral arthrodesis in lumbar spine surgery using autologous platelet-rich plasma and cancellous bone substitute: an osteoinductive and osteoconductive effect. Global Spine J. 2014 Aug;4(3):137-42. doi: 10.1055/s-0034-1376157. Epub 2014 May 3.
PubMed 25083353
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Platelet-Rich-Plasma in Posterolateral Lumbar Fusion
- ClinicalTrials.gov ID
- NCT03779945
- Acronym / sponsor ID
- PRP in lumbar fusion
- Conditions
- Platelet-Rich Plasma
- Keywords
- PRP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2018 (estimated)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- 20 Jan 2020 (estimated)
- First posted
- 19 Dec 2018 (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 objective of this study is to evaluate the fusion rate after the use of platelet rich plasma with autolgus bone graft and comparing it with bone graft alone
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.
A total of 104 patients treated with single level degenerative or lytic lumbar Spondylolisthesis indicated for PLF will be included ,patients will be classified into 2 groups Group A:Of 52 patients PLF + autologus bone graft+ PRP Group B: Of 52 patients treated with PLF + autologus bone graft only without adding PRP
Methods of evaluation
- History taking.
- Full clinical and neurological examination
- Radiological evaluation by x-ray (antero posterior, lateral, and, CT scans provide excellent views of bony detail) and MRI if needed Method of randomization By shuffling cards method the candidate patient will choose one card from104 cards 52 of them containing fusion with PRP and the other 52 contaning Fusion without PRP
Platelet-rich plasma (PRP 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 Ethylenediaminetetra acetic 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 specimen
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 |
|---|---|---|
| posteriolateral lumbar fusion +bone graft+ PRP | Active comparator | Biological: autologous platelet rich plasmathe addition of autologous platelet rich plasma to the bone graft |
| posteriolateral lumbar fusion+bone graft only | Active comparator | Procedure: posteriolateral lumbar fusion onlyposteriolateral lumbar fusion with adding autologus bone graft alone posteriolateral lumbar fusion only |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- degenerative or lytic Spondylolisthesis.
- Degenerative disc disease requiring posterior lumbar fusion not responding to medical treatment for 1 year.
- Age between 20 \& 75 years.
- Single level fusion
Key exclusion criteria (1 listed)
- Multiple levels patient Traumatic Spondylolisthesis Previous lumbar spine surgery. Other lumbar spine pathology severe osteoporosis Patients younger than 20 years old. Patients older than 75 years old. Immunocompromised patients (eg. Chronic renal failure)
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 | posteriolateral lumbar fusion +bone graft+ PRP |
| posteriolateral lumbar fusion onlyperforming posteriolateral lumbar fusion without using platelet rich plasma | Procedure or surgery | posteriolateral lumbar fusion+bone graft only |
Primary outcome
Lenke classification of posterolateral fusion success
Time frame: 6 month to1 year post-operative
the degree of bridging bone across the fused vertebral bodies by using xray and CT scan
2 secondary outcomes
modified Oswestry disability index ,
Time frame: 6 month to 1 year post-operative
visual analogue scale
Time frame: 6 month to 1 year post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Background: PubMed 28735763Kubota G, Kamoda H, Orita S, Yamauchi K, Sakuma Y, Oikawa Y, Inage K, Sainoh T, Sato J, Ito M, Yamashita M, Nakamura J, Suzuki T, Takahashi K, Ohtori S. Platelet-rich plasma enhances bone union in posterolateral lumbar fusion: A prospective randomized controlled trial. Spine J. 2019 Feb;19(2):e34-e40. doi: 10.1016/j.spinee.2017.07.167. Epub 2017 Jul 20.
- Background: PubMed 27833116Shiga Y, Orita S, Kubota G, Kamoda H, Yamashita M, Matsuura Y, Yamauchi K, Eguchi Y, Suzuki M, Inage K, Sainoh T, Sato J, Fujimoto K, Abe K, Kanamoto H, Inoue M, Kinoshita H, Aoki Y, Toyone T, Furuya T, Koda M, Takahashi K, Ohtori S. Freeze-Dried Platelet-Rich Plasma Accelerates Bone Union with Adequate Rigidity in Posterolateral Lumbar Fusion Surgery Model in Rats. Sci Rep. 2016 Nov 11;6:36715. doi: 10.1038/srep36715.
- Background: PubMed 29238638Imagama S, Ando K, Kobayashi K, Ishikawa Y, Nakamura H, Hida T, Ito K, Tsushima M, Matsumoto A, Morozumi M, Tanaka S, Machino M, Ota K, Nakashima H, Takamatsu J, Matsushita T, Nishida Y, Ishiguro N, Matsuyama Y. Efficacy of Early Fusion With Local Bone Graft and Platelet-Rich Plasma in Lumbar Spinal Fusion Surgery Followed Over 10 Years. Global Spine J. 2017 Dec;7(8):749-755. doi: 10.1177/2192568217696690. Epub 2017 Apr 11.
- Background: PubMed 25083353Tarantino R, Donnarumma P, Mancarella C, Rullo M, Ferrazza G, Barrella G, Martini S, Delfini R. Posterolateral arthrodesis in lumbar spine surgery using autologous platelet-rich plasma and cancellous bone substitute: an osteoinductive and osteoconductive effect. Global Spine J. 2014 Aug;4(3):137-42. doi: 10.1055/s-0034-1376157. Epub 2014 May 3.
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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.
El Moataz A Zohny El Sabrout, professor study chair
Assiut University
Essam M Abdelmoneim Elmorshedy, Lecturer principal investigator
Assiut University
. Belal O Mohamed Elnady, Lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing autologous platelet rich plasma and posteriolateral lumbar fusion only in people with Platelet-Rich Plasma, 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 1 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 20 Dec 2018. 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 Micheal B Elia, doctor (01282682989 ext. +2, mikelbassem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lenke classification of posterolateral fusion success (time frame: 6 month to1 year 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 NCT03779945, which also lists 4 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 20 Dec 2018.