NCT01266226

Brief Summary

The purpose of this study is to determine if autologous plasma (ACP) is beneficial for better and faster healing following an arthroscopic repair of the rotator cuff.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

2.2 years

First QC Date

December 22, 2010

Last Update Submit

May 19, 2015

Conditions

Rotator Cuff Tears

Keywords

Rotator cuff tearsACP

Outcome Measures

Primary Outcomes (1)

  • Oxford Shoulder Score

    The Oxford Shoulder Score used after 3 months is the primary parameter. The Score tests the ability to participate in the patients' normal life before they got injured.

    3mo (6mo/24mo)

Secondary Outcomes (9)

  • VAS Pain

    10d po

  • QuickDASH

    3/6/24mo

  • EQ-5D

    3/6/24 mo

  • ROM

    3/6/24mo

  • Measurement of the abduction strength

    3/6/24 mo

  • +4 more secondary outcomes

Study Arms (2)

ACP treated

EXPERIMENTAL

The patients are going to get an injection of 4mL autologous conditioned plasma under the footprint following an arthroscopic repair of the rotator cuff.

Device: Autologous conditioned plasma

Control group

PLACEBO COMPARATOR

The patients are going to get an injection of 4mL saline solution under the footprint following an arthroscopic repair of the rotator cuff.

Device: Control group

Interventions

Autologous conditioned plasmaDEVICE

4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.

Also known as: ACP Arthrex
ACP treated
Control groupDEVICE

4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.

Also known as: ACP Arthrex
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotator cuff tears (supraspinatus and/or infraspinatus tendon) performed by Dr. Flury and Dr. Schwyzer
  • Suture bridge technique
  • No pregnancy at the date of the surgery for women of childbearing potential
  • Signed consent form

You may not qualify if:

  • Partial reconstruction of the rotator cuff (PASTA)
  • Open reconstruction
  • Tendon transfer (latissimus dorsi or pectoralis major)
  • Revision surgery
  • Omarthrosis (Level ≥ 2 Samilson \& Prieto)
  • Systemic arthritis
  • Rheumatoid arthritis
  • Diabetes (insulin treated)
  • Requiring surgery in reconstruction of the subscapularis tendon
  • Acute or chronic infection
  • Pathological bone metabolism
  • Insufficient perfusion in the affected arm
  • Neuromuscular disease in the affected arm
  • Non compliance of the patient
  • Disorders which handicap or inhibit the patient to follow the orders of the clinical testers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, Canton Zürich, 8008, Switzerland

Location

Related Publications (1)

  • Flury M, Rickenbacher D, Schwyzer HK, Jung C, Schneider MM, Stahnke K, Goldhahn J, Audige L. Does Pure Platelet-Rich Plasma Affect Postoperative Clinical Outcomes After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial. Am J Sports Med. 2016 Aug;44(8):2136-46. doi: 10.1177/0363546516645518. Epub 2016 May 16.

    PMID: 27184542DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Matthias Flury, Dr

    Upper Extremities Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 24, 2010

Study Start

December 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2015

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

CH(1)