Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02050087
Other study ID # 2012/2288
Secondary ID
Status Completed
Phase N/A
First received January 28, 2014
Last updated May 30, 2017
Start date October 2013
Est. completion date January 2017

Study information

Verified date May 2017
Source Lovisenberg Diakonale Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.


Description:

Rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. Our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. Our aim is also to establish guidelines for timing of return to work. The major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. The information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date January 2017
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon -

Exclusion Criteria: Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon.

Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration >grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Simple sling.

Neutral brace


Locations

Country Name City State
Norway Lovisenberg Diaconal Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Lovisenberg Diakonale Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint. We will compare WORC of the early range of motion group to a delayed range of motion group. One year
See also
  Status Clinical Trial Phase
Recruiting NCT05727345 - Shoulder Anterior Capsular Block and Interscalene Brachial Plexus Block for Shoulder Arthroscopy N/A
Completed NCT01510639 - The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery Phase 3
Completed NCT05453266 - Arthroscopic Rotator Cuff Repair Performed With Intraarticular Tranexamic Acid Could it Provide Improved Visual Clarity and Less Post-operative Pain? A Prospective, Double Blind, Randomized Study of 64 Patients. N/A