Influence of Intraoperative Repair Tension on Postoperative Healing of Full-thickness Rotator Cuff Tears

NCT03318627 | Withdrawn

• 1 other identifier: 2015-00236
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• Tendon tension

  Measuring tendon Tension according to the footprint in 0° and 45° abduction with a Newtonmeter.

  during surgery

Secondary Outcomes (1)

• Rotator cuff re-tear

  one year

Study Arms (1)

Tension Measuring

OTHER

Measuring intraoperative tension of rotator cuff tendon with sterile spring Balance.

Device: Sterile Spring Scale

Interventions

Sterile Spring Scale DEVICE

Measuring intraoperative tension of tendon of rotator cuff tear

Tension Measuring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Balgrist University Hospital: lead

Related Publications (5)

• Le BT, Wu XL, Lam PH, Murrell GA. Factors predicting rotator cuff retears: an analysis of 1000 consecutive rotator cuff repairs. Am J Sports Med. 2014 May;42(5):1134-42. doi: 10.1177/0363546514525336. Epub 2014 Apr 18.

  PMID: 24748610 BACKGROUND

• Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.

  PMID: 15930531 BACKGROUND

• Thomazeau H, Boukobza E, Morcet N, Chaperon J, Langlais F. Prediction of rotator cuff repair results by magnetic resonance imaging. Clin Orthop Relat Res. 1997 Nov;(344):275-83.

  PMID: 9372778 BACKGROUND

• Meyer DC, Wieser K, Farshad M, Gerber C. Retraction of supraspinatus muscle and tendon as predictors of success of rotator cuff repair. Am J Sports Med. 2012 Oct;40(10):2242-7. doi: 10.1177/0363546512457587. Epub 2012 Aug 27.

  PMID: 22926748 BACKGROUND

• Liem D, Lichtenberg S, Magosch P, Habermeyer P. Magnetic resonance imaging of arthroscopic supraspinatus tendon repair. J Bone Joint Surg Am. 2007 Aug;89(8):1770-6. doi: 10.2106/JBJS.F.00749.

  PMID: 17671017 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: October 24, 2017
• Study Start: July 6, 2020
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share