Polyester Patch in Massive Rotator Cuff Repair Improves Healing

Rotator Cuff Tear Clinical Trial

Official title:

Application of a New Polyester Patch in Arthroscopic Massive Rotator Cuff Repair Significantly Improves Clinical Outcome and Tendon Integrity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976285
• Other study ID #: PitchPatch54
• Status: Completed
• Phase: N/A
• First received: November 15, 2016
• Last updated: November 23, 2016
• Start date: June 2012
• Est. completion date: August 2015

Study information

• Verified date: November 2016
• Source: Etzel Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. The investigators hypothesized that implanting this patch will improve individual shoulder function, while reducing re-tear rates compared to the current literature.

Description:

To evaluate this, patches were implanted into 54 shoulders and prospectively followed up clinically and radiologically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria were age greater 18 years and a RC tear involving at least two tendons, presenting a massive RC-tear as described by Gerber et al.

Exclusion Criteria:

• We excluded patients older than 75, fatty infiltration grade 4 according to Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Procedure:
• arthroscopic rotator cuff repair with a polyester patch
Patients were operated under general anesthesia and a supraclavicular nerve block, in a beach-chair position with 80° forward shoulder flexion and traction between 3-5 kg. After washing and draping a standard viewing portal was placed at the dorsal softspot. Further portals included, a lateral, a dorso-lateral, an antero-lateral and an anterior portal. If additional pathologies were present, they were treated simultaneously and mostly involved the long head of the biceps tendon, treated with tenodesis or tenotomy respectively. After a thorough bursectomy, the rupture was fully visualized and thereafter its size was estimated. Following debridement of the footprint, we used a triple row repair and implanted the patch.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Etzel Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function assessed with the Constant-Murley-Score		25 months	No
Primary	Function assessed with the Subjective Shoulder Value		25 months	No
Secondary	Tendon integrity evaluated radiologically		1-35 months	No