Osseointegrated Transdermal Femoral Amputation Prostheses

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT05736640

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osseointegrated Implants Bone Mineral Density	Drug: Denosumab Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Denosumab on Periprosthetic Bone Mineral Density in Six Transfemoral Amputees Treated With Osseointegrated Implants: The Observations From a Terminated Randomized Controlled Trial

Actual Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Sep 20, 2016

Actual Study Completion Date :

Sep 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Denosumab	Drug: Denosumab
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Active Comparator: Denosumab

Drug: Denosumab

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

change in periprosthetic bone mineral density [30 months po]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT05736640

Other Study ID Numbers:

34964

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 22, 2023

Last Verified:

Feb 1, 2023

Additional relevant MeSH terms:

Denosumab

Study Results

No Results Posted as of Feb 22, 2023