Osseointegrated Transdermal Femoral Amputation Prostheses

NCT05736640 | Completed DMC

• 1 other identifier: 34964
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osseointegrated Implants; Bone Mineral Density

Outcome Measures

Primary Outcomes (1)

• change in periprosthetic bone mineral density

  30 months po

Study Arms (2)

Denosumab

ACTIVE COMPARATOR

Drug: Denosumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Denosumab DRUG

Denosumab

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 21, 2023
• Study Start: September 1, 2013
• Primary Completion: September 20, 2016
• Study Completion: September 30, 2016
• Last Updated: April 21, 2023

Record last verified: 2023-02