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Influence of Intraoperative Repair Tension on Postoperative Healing of Full-thickness Rotator Cuff Tears (TENS-RCT)

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ClinicalTrials.gov Identifier: NCT03318627
Recruitment Status : Withdrawn (No capacity to conduct the study)
First Posted : October 24, 2017
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Balgrist University Hospital

Brief Summary:

Relevant problems of rotator cuff repair:

  • High retear rate after rotator cuff repair of 13%, despite regard of the criteria for "reparability" of a tear.
  • Long and exhausting rehabilitation after rotator cuff repair with an abduction splint for six weeks.

Hypothesis:

The investigators believe that high tension repair has a higher retear rate than low tension repair, regardless of the tear size. The investigators also believe that abduction of the arm can reduce relevant tension on the repair. But not each repair benefits equally from this.

Relevance of this hypothesis:

The ingenious advantage of this new parameter (intraoperative repair tension) is, that it can be influenced. In future, if this hypothesis would be true, the repair tension could be reduced intraoperative by release, side-to-side (margin convergence) repair or medialization of the footprint and thereby convert a high risk to a low risk tension repair.

Moreover, it could be that patients with a low tension repair does not necessarily have to wear an abduction splint. And on the other hand, high tension repair patients should probably wear the abduction splint longer with gradually reduction.

Approach:

The present research plan focused on a new intraoperative (arthroscopic) determinable parameter ("repair tension" on footprint in 0° and 40° abduction) to determine the risk of recurrence after tendon repair in rotator cuff tears, which are pre- and intraoperative defined as "reparable". Therefore, the tension of the repaired tendon is measured intraoperative with a spring balance (newtonmeter) and correlated with the postoperative retear-rate.

• Measure intraoperative repair tension with the arm in 0° and 40° of abduction


Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Device: Sterile Spring Scale Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Intraoperative Repair Tension on Postoperative Healing of Full-thickness Rotator Cuff Tears
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Tension Measuring
Measuring intraoperative tension of rotator cuff tendon with sterile spring Balance.
Device: Sterile Spring Scale
Measuring intraoperative tension of tendon of rotator cuff tear




Primary Outcome Measures :
  1. Tendon tension [ Time Frame: during surgery ]
    Measuring tendon Tension according to the footprint in 0° and 45° abduction with a Newtonmeter.


Secondary Outcome Measures :
  1. Rotator cuff re-tear [ Time Frame: one year ]
    Evaluation re-tear of repaired rotator cuff in MRI scan



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Male/female from 18-99 years
  • All arthroscopic reparable transmural supra-/infraspinatus tears
  • German speaking

Exclusion Criteria:

  • Previous operation on the ipsilateral rotator cuff
  • Irreparable rotator cuff tear (supra- and / or infraspinatus and / or subscapularis)
  • static antero-superior subluxation of humeral head
  • dynamic antero-superior subluxation of humeral head
  • pseudoparalysis for anteflexion, hornblow sign, dropping- arm sign
  • fatty infiltration goutallier 3-4 (MRI)
  • reduced acromiohumeral distance <7mm (RX)
  • intraoperative not reparable
  • Mild/severe osteoarthritis (RX, Hamada II-IV)
  • Inability of patient (language problems, mental illness, dementia)
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Responsible Party: Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT03318627    
Other Study ID Numbers: 2015-00236
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries