Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

Rotator Cuff Tear Clinical Trial

Official title:

Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair With Double Row Technique in Small or Medium Ruptures. Prospective, Comparative and Randomized.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01502098
• Other study ID #: CEPI:1780
• Status: Recruiting
• Phase: N/A
• First received: December 24, 2011
• Last updated: January 9, 2012
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2012
• Source: Hospital Italiano de Buenos Aires
• Contact: Juan M. Lopez Ovenza, MD
• Phone: 15-5-9249686
• Email: juanmanuel.lopez[@]hospitalitaliano.org.ar
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

The study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients skeletally mature (older 18 years old)

• Small or medium rupture of rotator cuff

• Repaired with arthroscopic double row technique

Exclusion Criteria:

• Impossibility to perform MRI (claustrophobic, pacemaker, heart or brain metallic implants)

• AC arthritis with mumford procedure

• Smokers

• Diabetes

• Postoperative complication (severe pain, thrombosis, infection)

• Psychiatric disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Procedure:
• Postoperative early passive motion
Shoulder exercises starting on the first postoperative day

Other:
• Sling
Sling for 4 weeks

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI		6 months	No
Secondary	ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale)	The ASES is 100-point standardized shoulder-assessment self-report form, 50 points of which are derived from patient self-report of pain on a visual analog scale and 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living derived using a four-point ordinal scale.	1, 3, 6 months	No
Secondary	Range of Motion		1, 3, 6 months	No
Secondary	VAS of pain	visual analogue scale of pain	1, 3, 6 months	No
Secondary	WORC	The Western Ontario Rotator Cuff Index (WORC) is a self-report questionnaire developed specifically to evaluate disability in persons with pathology of the rotator cuff of the shoulder.	1, 3, 6 months	No