Osseointegrated Transdermal Femoral Amputation Prostheses | NCT05736640

Studies
Osseointegrated Transdermal Femoral Amputation Prostheses

NCT05736640

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Apr 21, 2023Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Osseointegrated Implants
Bone Mineral Density

Interventions

Denosumab
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2013Actual

Primary Completion Date

Sep 20, 2016Actual

Completion Date

Sep 30, 2016Actual

First Submitted Date

Feb 8, 2023

First Submission Date that Met QC Criteria

Feb 8, 2023

First Posted Date

Feb 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2023

Last Update Posted Date

Apr 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Femur amputated patients often suffer from several problems with conventional socket prosthesis. Some experience changes in gait, discomfort when sitting, altered skin conditions (infection, irritation, rashes, sweat), phantom pain or lack of stabilization between the prosthesis and the residual limb. Many have a low score on "health-related quality of life" questionnaires (HRQL).

Some femur amputated patients may be a candidate to osseointegrated prosthesis. Osseointegrated prosthesis is an implant, where the fixture is inserted into the femur canal and an abutment screw, on which the leg-prostheses is inserted, protrudes the skin. By this procedure the patient have a high score on HRQL and experience fewer problems. They have improved gait, reduced discomfort when sitting, increased prosthetic use, and experience fewer skin and pain problems.

Femur amputee patients formerly mobilized on socket prosthesis have a reduced bone mineral density in the affected femur and pelvis.

The Phd-theses compromise of three studies. The aim of the first study is to follow patients with oosseointegrated prosthesis before and after surgery with DXA-scans to monitor the BMD. In the second study patients will be randomised to receive medical treatment with an RANKL-inhibitor, approved for treatment of osteoporosis, and monitored with DXA, microdialysis and radiostereometry. Depending on the DXA-results patients in the third study may receive fast track rehabilitation.

The hypothesis is that patients with osseointegrated prosthesis will have an increased BMD after surgery, 2 years follow up. Patients receiving RANKL inhibitor will have increased BMD, stability of the prosthesis, and some receive fast-track rehabilitation due to high BMD.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Denosumab	Active Comparator		Drug: Denosumab
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Denosumab	Drug		Denosumab
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in periprosthetic bone mineral density		30 months po

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18-70 years
Scheduled for OI-implant surgery
Body mass index <30
Female patients of childbearing age must produce a negative pregnancy test and use effective contraception
informed consent

Exclusion Criteria:

Diabetes with complication
Atherosclerosis
Smoking
Drug abuse
Treatment with NSAID or cytostatic
Active cancer
Liver or kidney insufficiency
Dementia
Hip flexion contracture on the affected side >10 degrees
Body weight >100 kg
Hypocalcaemia
Contraindications to denosumab

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069448	Denosumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

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