NCT00508105

Brief Summary

This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
8.4 years until next milestone

Results Posted

Study results publicly available

April 7, 2020

Completed
Last Updated

May 5, 2020

Status Verified

April 1, 2020

Enrollment Period

5.1 years

First QC Date

July 25, 2007

Results QC Date

May 29, 2017

Last Update Submit

April 27, 2020

Conditions

Subscapularis PeelMorselized Osteotomy

Keywords

OsteoarthritisShouldersubscapularis peelosteotomy

Outcome Measures

Primary Outcomes (1)

  • Subscapularis Strength

    Subscapularis muscle strength will be measured with an electronic handheld dynamometer. Patients are asked to press the dynamometer in towards their chest (belly-press) for a period of approximately 3 seconds before releasing. Strength is measured in kilograms of force.

    2 years

Secondary Outcomes (2)

  • Western Ontario Osteoarthritis of the Shoulder Index

    2 Years

  • American Shoulder and Elbow Score

    2 Years

Study Arms (2)

subscapularis peel

ACTIVE COMPARATOR
Procedure: subscapularis peel

osteotomy

ACTIVE COMPARATOR
Procedure: osteotomy

Interventions

subscapularis peelPROCEDURE

Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel".

Also known as: non applicable
subscapularis peel
osteotomyPROCEDURE

This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.

Also known as: non applicable
osteotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have failed standard non-surgical management of their shoulder arthritis who would benefit from a shoulder arthroplasty.

You may not qualify if:

  • Active joint or systemic infection
  • Significant muscle paralysis
  • Rotator cuff tear arthroplasty
  • Major medical illness
  • Unable to speak or read English/French
  • Psychiatric illness that precludes informed consent
  • Unwilling to be followed for 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hosptial

Ottawa, Ontario, K1y 4E9, Canada

Location

Related Publications (2)

  • Lapner PL, Sabri E, Rakhra K, Bell K, Athwal GS. Healing rates and subscapularis fatty infiltration after lesser tuberosity osteotomy versus subscapularis peel for exposure during shoulder arthroplasty. J Shoulder Elbow Surg. 2013 Mar;22(3):396-402. doi: 10.1016/j.jse.2012.05.031. Epub 2012 Sep 1.

    PMID: 22944077RESULT

  • Lapner PL, Sabri E, Rakhra K, Bell K, Athwal GS. Comparison of lesser tuberosity osteotomy to subscapularis peel in shoulder arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Dec 19;94(24):2239-46. doi: 10.2106/JBJS.K.01365.

    PMID: 23318614RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

Osteotomy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Peter Lapner
Organization
Ottawa Hospital Research Institute
plapner@toh.ca
613-737-8899

Study Officials

  • Peter Lapner, MD

    OHRI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 27, 2007

Study Start

November 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 5, 2020

Results First Posted

April 7, 2020

Record last verified: 2020-04

Locations

CA(1)