Autologous conditioned plasma injection for acute hamstring muscle injury.

Completed

• Conditions: hamstring rupture; hamstring strain; 10028302

• Registration Number: NL-OMON37939
• Lead Sponsor: Arthrex Medizinische Instrumente GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1.Clinical diagnosis of an acute hamstring injury, defined as:
- anamnestic acute injury
- anamnestic pain in posterior thigh
- localised pain during palpation of hamstring muscle
- localised pain during passive straight leg raising
- increasing pain during isometric contraction
AND
2.Hamstring lesion proven on MRI (increased signal in injured muscle on T2 and/or STIR)
AND
3. First injection will be performed maximal 5 days after injury
AND
4. Informed consent
AND
5. Age 18-50 year

Exclusion Criteria

1.Patient is not capable of doing an active exercise program
2.Patient has recieved injection therapy for this injury before
3. Patient does not have the intention to return to full sports activity
4.Patient does not want to recieve one of the two therapies
5.Cause of hamstring injury is an extrinsic trauma on posterior thigh
6.Patient has chronic low back pain
7.There are contraindications for MRI:pacemaker, pregnancy, claustrofobia
8.Patient has chronich hamstring complaints (> 2 months)
9.There is a grade 3 lesion (total rupture) on MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time to return to full sports activity; both training or match play.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Recovery assessed with a sevenpoints Likert scale, hamstring force, recurrent<br /><br>hamstring lesions, maximal and mean pain score in rest and during sprinting<br /><br>assessed with the visual analogue scale (VAS), pain with isometric contraction<br /><br>against resistance, length of pain area during palpation, clinical hamstring<br /><br>tests (passive straight leg raising, active knee extension, active slump test,<br /><br>taking shoe out sign), clinical sacroiliacal test (Stork test, multi test<br /><br>regime score, Gillet test), hip- and knee range of motion, functional outcome<br /><br>scores, subjective patient satisfaction, recovery of hamstringlesion on MRI<br /><br>(with reservation of financing), prediction of patient and sports physician for<br /><br>time to return to sports and prediction of the patient of the used intervention<br /><br>(ACP or placebo). Follow-up will be performed after 1, 3, 4, 6, 8, 10, 16, 26<br /><br>and 52 weeks. </p><br>