NCT01725711

Brief Summary

Patients with transfemoral amputations (TFA) frequently experience problems related to the use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps 4. The potential for improvement is substantial. Based on the very good long-term results with osseointegrated titanium implants for edentulous patients 5, osseointegrated hearing aids 6, cranio-facial prostheses 7 and prostheses for thumb-amputated patients 8, the clinical development of osseointegrated prostheses for TFA started in 1990, in Gothenburg, Sweden. The concept has gradually been modified and improved. In 1999, a prospective clinical trial began. The hypothesis is that the treatment will improve quality of life.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started May 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress96%
May 1999May 2027

Study Start

First participant enrolled

May 1, 1999

Completed
13.5 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
14.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

28 years

First QC Date

October 15, 2012

Last Update Submit

August 5, 2019

Conditions

Transfemoral Amputation

Outcome Measures

Primary Outcomes (1)

  • Q-TFA Prosthetic Use Score

    The primary efficacy variable is the change in Q-TFA Prosthetic Use Score as compared baseline.

    0,1,2,3,5,7,10,15,20 years

Study Arms (1)

Implant System

EXPERIMENTAL
Device: OPRA Implant System

Interventions

OPRA Implant SystemDEVICE
Implant System

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Transfemoral amputation

You may not qualify if:

  • Transfemoral amputation due to vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, VG, 413 45, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

November 14, 2012

Study Start

May 1, 1999

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

SE(1)