Osseointegrated Transdermal Femoral Amputation Prostheses

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osseointegrated Implants, Bone Mineral Density

Intervention / Treatment
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* Drug: Denosumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Denosumab<br> | Drug: Denosumab<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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