Clinical trial NCT03300531: Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease
Official title: Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease：A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rotator Cuff Tear
Lateral Epicondylitis
Achilles Tendinitis
Keywords: Pure Platelet-rich Plasma
Randomized Controlled Trial
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Xingyue Biotechnology Co., Ltd.
First posted: 2017-10-03
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis. Patients will be randomly divided into three groups. Autologous pure platlet-rich plasma (P-PRP) and platlet-rich plasma (PRP) are purified from the peripheral blood .Patients of case groups will receive P-PRP or PRP injection once a week for three times while the control group received the same dose compound betamethasone injection. Follow up visit will occur at 1 month,3 months, 6 months,12 months after the last injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.

Detailed description: All injection will be done under ultrasound guidance.

Eligibility criteria: Inclusion Criteria:

1. clinically diagnosed as rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis;
2. symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;
3. patient that can understand the clinical trials and signed the informed consent.

Exclusion Criteria:

1. patient that underwent other injection treatment within 6 weeks
2. some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
3. patient that enrolled other clinical trials within 3 months
4. history of drug/alcohol addiction, habitual smoker

Primary outcomes:
measure: Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary outcomes:
measure: Constant-Murley Score(CMS)
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
measure: The Disabilities of the Arm, Shoulder and Hand(DASH) Score
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
measure: Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A)
timeFrame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
measure: Adverse events
timeFrame: From baseline through study completion, an average of 3 year
Other outcomes:
Locations:
Study officials:
References:
citation: Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.