Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05051059 |
| Other study ID # |
S63146 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
April 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
Hazem Wafa |
| Phone |
+32 16 33 88 73 |
| Email |
hazem.wafa[@]uzleuven.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively
accounting for only 1% of all malignancies diagnosed. Sarcomas often occur in the patients'
extremities and treatment typically involves limb salvage surgery with bone and/or muscle
resection. These surgeries often leave the patients with disfigurements, psychological
trauma, and functional disabilities. Perhaps, the most difficult and life-altering decision
that patients (and their parents) with primary bone sarcomas about the knee joint have to
make, involves choosing the type of surgical procedure that will provide them with the
outcome that meets their functional as well as aesthetic expectations.
In literature, the quality of life for patients with osteosarcoma around the knee joint after
three different surgical procedures, that is, amputation, endoprosthetic reconstruction and
rotationplasty was evaluated. There was found that patients treated with rotationplasty
showed significantly higher functional scores compared to the two other groups of patients.
Also, researchers investigated the long-term quality of life after bone sarcoma surgery
around the knee joint and found that, despite the functional disability, survivors were busy
with work, study, relationships, and sometimes they have founded a family.
Most published reports in the literature on assessment of gait in the lower-extremity sarcoma
survivors were focused on bone sarcoma patients after wide resection and endoprosthetic
reconstruction. To the knowledge of the investigator, there has been no published studies on
gait analysis after resection of soft tissue sarcomas (STS) of the lower extremity. The rare
and heterogeneous aspects of STS and the paucity of knowledge of movement strategies in these
patients hinder the development of effective rehabilitation protocols for recovering movement
after resection of STS in the lower limb.
Description:
Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively
accounting for only 1% of all malignancies diagnosed. There have been dramatic improvements
in the survival rate of sarcoma patients in the past 40 years owing to increasing
effectiveness of chemotherapy. This, along with developments in imaging techniques, have led
to earlier diagnosis and more accurate preoperative staging. It is estimated that there are
nearly 50,000 survivors of bone and soft tissue sarcomas in the United States. 70% of those
are younger than the age of 50 years. Whilst traditional treatment for bone tumors used to be
amputation, advances in surgical techniques have made limb-salvage procedures a valid
alternative method of treatment in 80-85% of patients with primary bone sarcomas.
Sarcomas often occur in the patients' extremities and treatment typically involves limb
salvage surgery with bone and/or muscle resection. These surgeries often leave the patients
with disfigurements, psychological trauma, and functional disabilities. Perhaps, the most
difficult and life-altering decision that patients (and their parents) with primary bone
sarcomas about the knee joint have to make, involves choosing the type of surgical procedure
that will provide them with the outcome that meets their functional as well as aesthetic
expectations. In literature, the quality of life for patients with osteosarcoma around the
knee joint after three different surgical procedures, that is, amputation, endoprosthetic
reconstruction and rotationplasty was evaluated. There was found that patients treated with
rotationplasty showed significantly higher functional scores compared to the two other groups
of patients. Also, researchers investigated the long-term quality of life after bone sarcoma
surgery around the knee joint and found that, despite the functional disability, survivors
were busy with work, study, relationships, and sometimes they have founded a family.
There are few reports available in the literature on the quality of life in sarcoma
survivors. It was found that elderly patients, retired patients, and those who live alone
need more intensive psychological care. Female patients were found to cope poorly with their
disease compared to male gender. It was also found that the physical status greatly
influences the overall outcome and quality of life in this group of patients. This stresses
the importance of enrolment in tailored rehabilitation programs.
Most published reports in the literature on assessment of gait in the lower-extremity sarcoma
survivors were focused on bone sarcoma patients after wide resection and endoprosthetic
reconstruction. In literature, the gait pattern after endoprosthetic replacement around the
knee joint was studied and found that, despite decreased walking velocity, stride length, and
stance phase of the operated limb, these patients still have a symmetrical gait. Also in
another report, an electromyographic assessment of gait after bone sarcoma surgery about the
knee showed prolonged activation of rectus femoris and hamstring muscles in the affected limb
compared to a control group. Other researchers found that limb-salvage patients often adopt a
"stiff-legged" gait pattern. These findings are of utmost importance for the development of
efficient rehabilitation programs for these patients.
To the knowledge of the investigator, there has been no published studies on gait analysis
after resection of soft tissue sarcomas (STS) of the lower extremity. The rare and
heterogeneous aspects of STS and the paucity of knowledge of movement strategies in these
patients hinder the development of effective rehabilitation protocols for recovering movement
after resection of STS in the lower limb. Researchers investigated the knee extension
strength and postoperative functional outcome after quadriceps resection for soft tissue
sarcoma of the thigh. They found that knee extension strength decreased when the number of
resected quadriceps increased and this was associated with lower functional scores. They
concluded that good functional results can be expected if at least two quadriceps muscles are
preserved. However, no detailed assessment of gait in this group of patients has been
published.
