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NCT Number: NCT05051059

Assessment of the Functional Outcome and Quality of Life in Sarcoma Patients

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent limb salvage surgery for bone or soft tissue sarcoma of the lower extremity at UZ Leuven
  • 18 to 95 years old
  • Patients should be at least one year post surgery
  • Informed consent has obtained

Exclusion criteria

  • Patients who received major prior surgery of the lower limbs or with any pathology, injury or disorder known to affect the locomotor system
  • Skeletally immature individuals
  • No informed consent has obtained

Treatment and study plan

Functional outcome

Other

3D-motion analysis and strength assessment

Health related quality of life (HRQoL) assessment

Other

Quality of Life Questionnaire C-30 (QLQ-C30), Impact on Participation and Autonomy Questionnaire (IPAQ) and Musculoskeletal Tumor Society Score (MSTS)

Primary outcomes

  1. Musculoskeletal Tumor Society Score (MSTS)

    Time frame: Within a period of 1 year

    To determine the physical and mental health for patients with extremity sarcoma

  2. Quality of Life Questionnaire C-30 (QLQ-C30)

    Time frame: Within a period of 1 year

    To measure cancer patients' physical, psychological and social functions

  3. Participation and Autonomy Questionnaire Questionnaire (IPAQ)

    Time frame: Within a period of 1 year

    To measure health-related physical activity

Study contacts

Contact information is provided by the study sponsor or research team.

Hazem Wafa

CONTACT

[email protected]

+32 16 33 88 73

Moke Lieven

CONTACT

[email protected]

+32 16 34 08 84

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: QOLSarcoma

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2021
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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