NCT04798742

Brief Summary

Gluteus maximus transfer following THA does not improve abductor strength - a case-control gait analysis study of 15 patients with gluteus medius disruption The investigators have compared 15 gluteus maximus transferred patients with the use of a gait analysis system based on reflective markers and force plates to objectively evaluate the gait performance pre- and postoperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

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

February 1, 2012

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

6.6 years

First QC Date

February 24, 2021

Last Update Submit

July 2, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Abductor strength measurement with use of an optical tracking system after Gluteus maximus transfer - a case-control gait analysis study of 15 patients pre- and postoperative with gluteus medius disruption

    Gait analysis examination/measure will be performed preoperative with an optical tracking system in a gait laboratory using reflective markers and integrated force plates in order to record kinetics (Nm/kg) of abductor muscles moment in the frontal plane.

    Preop

  • Abductor strength measurement with use of an optical tracking system after Gluteus maximus transfer- a case-control gait analysis study of 15 patients pre- and postoperative with gluteus medius disruption

    Gait analysis examination/measure will be performed 2 year postoperative with an optical tracking system in a gait laboratory using reflective markers and integrated force plates in order to record kinetics (Nm/kg) of abductor muscles moment in the frontal plane.

    Postop 2 year

Study Arms (2)

Gait performance preop vs postop

EXPERIMENTAL

Pre and postop

Procedure: Gluteus maximus transfer

Gait performance postop vs controls

EXPERIMENTAL

Postop vs controls

Procedure: Gluteus maximus transfer

Interventions

Gait analysis study of 15 patients with gluteus medius disruption

Gait performance postop vs controlsGait performance preop vs postop

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA)

You may not qualify if:

  • THA prior to the muscle transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roland Zügner

Gothenburg, SE 41310, Sweden

Location

Related Publications (1)

  • Whiteside LA. Surgical technique: Transfer of the anterior portion of the gluteus maximus muscle for abductor deficiency of the hip. Clin Orthop Relat Res. 2012 Feb;470(2):503-10. doi: 10.1007/s11999-011-1975-y.

Study Officials

  • Roland Zügner

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 15, 2021

Study Start

February 1, 2012

Primary Completion

September 17, 2018

Study Completion

September 17, 2018

Last Updated

July 7, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

After publication, all available data will be available by appointment and within a reasonable time.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After publication and 2 years after publication

Locations