Microfracture in Rotator Cuff Injury Repair

Rupture of the Rotator Cuff Clinical Trial

Official title:

Microfracture in Rotator Cuff Injury Repair

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02097901
• Other study ID #: SJ-370
• Status: Suspended
• Phase: N/A
• First received: March 17, 2014
• Last updated: January 27, 2017
• Start date: March 2014
• Est. completion date: March 2018

Study information

• Verified date: January 2017
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to repair with or without microfracture.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over the age of 18 with a full thickness rotatorcuff rupture.

Exclusion Criteria:

• Isolated rupture of the subscapularis

• Tendon atrophia

• Goutallier grade 3-4 fatty degeneration

• Fracture surgery in same shoulder

• Inflammatory or neurologic affection of shoulder

• Other disabling disease

• Unwilling to participate in study

Related Conditions & MeSH terms

• Rupture
• Rupture of the Rotator Cuff

Intervention

Procedure:
• Microfracture
Rotator Cuff Repair AND Microfracture
• NO microfracture
Rotator Cuff Repair without microfracture

Locations

Country	Name	City	State
Denmark	Køge Sygehus	Køge	Lykkebækvej 1

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Strength of rotatorcuff	Strength 0-5 in abduction and external rotation.	3 and 12 months
Other	Function of rotatorcuff	Range of movement in abduction and external rotation in full degrees.	3 and 12 months
Other	Complications	Assesses the complication rate in each group such as infection, bleeding and reoperation.	12 months
Primary	Change in Western Ontario Rotator Cuff Index (WORC)	Standardized questionnaire	0, 3 and 12 months
Primary	Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)	Standardized questionnaire	0, 3 and 12 months
Secondary	MRI integrity of the rotatorcuff	Intact rotatorcuff; Partial rupture; Full thickness rupture	12 months