Sports InjuryPhase 1NCT04659447

Clinical Study of Platelet-rich Plasma Promoting Tendon-bone Healing in Anterior Cruciate Ligament Reconstruction

A Phase 1 study testing Platelet-Rich Plasma in people with Sports Injury, run by Beijing Tsinghua Chang Gung Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 15 to 50 years
Conditions the study is for: Sports Injury
What is being tested?: Platelet-Rich Plasma
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: 1 Jul 2016to 9 Nov 2021
Phase: Phase 1
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 15 to 50 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

History of knee injury
History of knee instability
Anterior drawer test (+), or / and Lachman test (+)
The tear of anterior cruciate ligament was confirmed by MRI

Who cannot join

The injury of other ligaments of knee joint, such as complex posterior cruciate ligament injury, lateral collateral ligament injury and medial collateral ligament injury above III degree
Patients with meniscus removed
Patients with moderate to severe articular cartilage injury
Patients with complex nerves and blood vessels injury
Patients with compound intra - and periarticular fractures of the knee
Patients with intra or periarticular fractures of the knee
Patients with contralateral knee instability
Patients with severe cardiovascular and cerebrovascular diseases

About this study

Anterior cruciate ligament (ACL) injury is a common knee injury, which seriously affects the living ability and sport level of the injured. ACL reconstruction is the main method to treat ACL injury. Due to the reconstructive ligament needs a tendon bone healing and ligament maturation, therefore, in the ACL anatomical study, reconstruction surgery and reconstruction materials under the condition of constant progress, how to improve the ACL reconstruction of tendon bone healing and shorten the time of the ligament mature, improve the clinical effect of ACL reconstruction, has become the focus in the ACL reconstruction.

Autologous platelet-rich plasma (PRP) is full of growth factors and bioactive factors, which has the function of promoting tissue healing, anti-inflammatory and analgesic effects. At the same time of anterior cruciate ligament reconstruction, using autologous PRP in the bone channel might promote tendon bone healing and ligament maturing after ACL reconstruction, promote the recovery of proprioception, prevent bone channel expanding, shorten the postoperative recovery time, speed up the patients recovery exercise ability, improve the clinical effect of ACL reconstruction.

In this study, patients with ACL injuries were randomly divided into two groups: one group underwent ACL anatomical reconstruction, and the other group underwent ACL anatomical reconstruction with PRP. Various clinical scores, KT-2000, Biodex and imaging tests were used to evaluate the differences in the clinical effects of the two surgical methods in terms of postoperative pain, joint swelling, knee function, joint stability, muscle strength recovery, bone channel expanding, ligament vasinization, and ligament maturation.

Conditions: Sports Injury
Being tested: Platelet-Rich Plasma
Keywords: Anterior Cruciate Ligament Tear, platelet-rich plasma
Medical subject headings: Athletic Injuries, Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Platelet-Rich PlasmaDrug
36 ml of peripheral blood is extracted from patients, and 4 ml of 3.8% sodium citrate is added for anticoagulation. After centrifugation for 2 times, 4 ml platelet-rich plasma will be prepared.Four semitendinosus tendons and gracilis tendons are prepared.

Study groups in NCT04659447
Study group	Role	What they receive
Platelet-Rich Plasma	Experimental	Four semitendinosus tendons and gracilis tendons are prepared. 4 ml platelet-rich plasma is completely absorbed by a gelatin sponge and fixed in the center of the four tendons. 4-0 absorbable line is used for fixation.Then we use conventional surgical techniques to reconstruct the ACL. Receives: Drug: Platelet-Rich Plasma
control group	No intervention	We performed conventional surgical techniques to reconstruction without using platelet-rich plasma.

What is being measured

The primary outcome is the main question the study is designed to answer.

tendon bone healing and ligament maturing
The diameter of bone canal was evaluated by CT, it is measured in millimeters (mm).
The tendon bone healing and ligament maturing was evaluated by MRI. According to the same level of anterior cruciate ligament, femoral canal, posterior cruciate ligament, background noise, with the diameter of 3.3 mm as the center, the lowest signal value point was measured, and the final point was compared to obtain the Signal-Noise Ratio.
Measured: CT and MRI were performed on the fourth day after operation
tendon bone healing and ligament maturing
The diameter of bone canal was evaluated by CT, it is measured in millimeters (mm).
The tendon bone healing and ligament maturing was evaluated by MRI. According to the same level of anterior cruciate ligament, femoral canal, posterior cruciate ligament, background noise, with the diameter of 3.3 mm as the center, the lowest signal value point was measured, and the final point was compared to obtain the Signal-Noise Ratio.
Measured: CT and MRI were performed on one year after operation
proprioception and Knee joint function
KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters.
Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
Measured: 3 months after the operation
proprioception and Knee joint function
KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters.
Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
Measured: 6 months after the operation
proprioception and Knee joint function
KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters.
Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
Measured: 1 year after the operation
Knee pain
Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
Measured: 3 months after the operation
Knee pain
Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
Measured: 6 months after the operation
Knee pain
Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
Measured: 1 year after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20169 Nov 2021

First posted9 Dec 2020
Study start1 Jul 2016
Primary completion9 Nov 2021 (estimated)
Study completion9 Nov 2021 (estimated)

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 Sports InjuryStudies of the same condition, open and under way.
More trials run by Beijing Tsinghua Chang Gung 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04659447
Sponsor's protocol ID: 12017B3003
Status last verified: Dec 2020
First submitted: 23 Nov 2020
Last updated: 9 Dec 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Gong H, Huang B, Zheng Z, Fu L, Chen L. Clinical Use of Platelet-Rich Plasma to Promote Tendon-Bone Healing and Graft Maturation in Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Study. Indian J Orthop. 2022 Jan 27;56(5):805-811. doi: 10.1007/s43465-021-00533-z. eCollection 2022 May.
PubMed 35103026

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
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Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
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Integrating Sport-Specific Comprehensive Training to Upscale Performance in Women and Girls
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All Sports Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of Platelet-rich Plasma Promoting Tendon-bone Healing in Anterior Cruciate Ligament Reconstruction
ClinicalTrials.gov ID: NCT04659447
Acronym / sponsor ID: 12017B3003
Conditions: Sports Injury
Keywords: Anterior Cruciate Ligament Tear, platelet-rich plasma
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (actual)
Lead sponsor: Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
Study start: 1 Jul 2016 (actual)
Primary completion: 9 Nov 2021 (estimated)
Study completion: 9 Nov 2021 (estimated)
First posted: 9 Dec 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Platelet-Rich Plasma	Experimental	Drug: Platelet-Rich PlasmaFour semitendinosus tendons and gracilis tendons are prepared. 4 ml platelet-rich plasma is completely absorbed by a gelatin sponge and fixed in the center of the four tendons. 4-0 absorbable line is used for fixation.Then we use conventional surgical techniques to reconstruct the ACL.
control group	No intervention	–We performed conventional surgical techniques to reconstruction without using platelet-rich plasma.

Who may qualify

Ages: 15 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

History of knee injury
History of knee instability
Anterior drawer test (+), or / and Lachman test (+)
The tear of anterior cruciate ligament was confirmed by MRI

Key exclusion criteria (8 listed)

The injury of other ligaments of knee joint, such as complex posterior cruciate ligament injury, lateral collateral ligament injury and medial collateral ligament injury above III degree
Patients with meniscus removed
Patients with moderate to severe articular cartilage injury
Patients with complex nerves and blood vessels injury
Patients with compound intra - and periarticular fractures of the 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 Plasma36 ml of peripheral blood is extracted from patients, and 4 ml of 3.8% sodium citrate is added for anticoagulation. After centrifugation for 2 times, 4 ml platelet-rich plasma will be prepared.Four semitendinosus tendons and gracilis tendons are prepared.	Drug	Platelet-Rich Plasma

Primary outcome

tendon bone healing and ligament maturing
Time frame: CT and MRI were performed on the fourth day after operation
The diameter of bone canal was evaluated by CT, it is measured in millimeters (mm). The tendon bone healing and ligament maturing was evaluated by MRI. According to the same level of anterior cruciate ligament, femoral canal, posterior cruciate ligament, background noise, with the diameter of 3.3 mm as the center, the lowest signal value point was measured, and the final point was compared to obtain the Signal-Noise Ratio.
tendon bone healing and ligament maturing
Time frame: CT and MRI were performed on one year after operation
The diameter of bone canal was evaluated by CT, it is measured in millimeters (mm). The tendon bone healing and ligament maturing was evaluated by MRI. According to the same level of anterior cruciate ligament, femoral canal, posterior cruciate ligament, background noise, with the diameter of 3.3 mm as the center, the lowest signal value point was measured, and the final point was compared to obtain the Signal-Noise Ratio.
proprioception and Knee joint function
Time frame: 3 months after the operation
KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters. Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
proprioception and Knee joint function
Time frame: 6 months after the operation
KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters. Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
proprioception and Knee joint function
Time frame: 1 year after the operation
KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters. Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
Knee pain
Time frame: 3 months after the operation
Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
Knee pain
Time frame: 6 months after the operation
Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
Knee pain
Time frame: 1 year after the operation
Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
Derived from this study: PubMed 35103026Gong H, Huang B, Zheng Z, Fu L, Chen L. Clinical Use of Platelet-Rich Plasma to Promote Tendon-Bone Healing and Graft Maturation in Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Study. Indian J Orthop. 2022 Jan 27;56(5):805-811. doi: 10.1007/s43465-021-00533-z. eCollection 2022 May.

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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Platelet-Rich Plasma in people with Sports Injury, run by Beijing Tsinghua Chang Gung 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 4 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: status not confirmed, as of the sponsor's last update on 9 Dec 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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?

tendon bone healing and ligament maturing (time frame: CT and MRI were performed on the fourth day after operation). The study lists 8 primary outcomes in all. 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 NCT04659447, 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 9 Dec 2020.