TEPStabil - Muscle Function and Dynamic and Postural Stability in Patients Receiving Hip or Knee Arthroplasty

University Hospital Basel

Status: Completed

Conditions: Postural Stability

Treatments: Diagnostic Test: Postural stability test; Diagnostic Test: Muscle activity test; Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L); Diagnostic Test: Dynamic stability test during level and uphill walking; Diagnostic Test: Passive range of motion; Diagnostic Test: Muscle strength test; Diagnostic Test: HOOS/ KOOS

Study type: Observational

Funder types: Other

Identifiers

NCT03860610

2018-02159 ch19Muendermann;

Details and patient eligibility

About

Study 1 is to determine if muscle strength and dynamic and postural stability are compromised in patients with severe hip or knee Osteoarthritis (OA) and in patients after THA and TKA.

Study 2 is to quantify the effect of THA and TKA on muscle strength and dynamic and postural stability.

Full description

Postural stability is defined as the ability to maintain the body's centre of gravity within the limits of stability as determined by the base of support. It is further divided in static and dynamic stability involving the ability of maintaining a base of support while standing or completing a functional Task. The importance of postural stability is accepted as a factor predicting falls and affecting the ability to perform activities of daily living.

Despite of reported strength deficits and the importance of balance, to date the potential contribution of strength deficits in patients before and after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA) to compromised balance ability is unknown. Furthermore, the role of preoperative muscle function on functional outcome of THA and TKA is poorly understood. A correlation between compromised preoperative muscular function and postoperative outcome would suggest that preoperative physical therapy may be critical for preserving the muscular status and may help explain reported poorer outcome after late treatment when muscular function has already deteriorated.

The project includes two studies differing in design and primary and secondary objectives but with overlapping patient populations.

Study 1 will include all five groups, and there is only one visit by the participant (visit A).

Study 2 will include only patients from groups 3 and 4. Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3). Visit 1 will be identical to visit A in study 1 in these two patient groups.

Enrollment: 130 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with an unilateral THA or TKA, which they received for the treatment of osteoarthritis (Patient groups 1+2)
• Patients diagnosed with unilateral OA of the knee or hip planned for a treatment with THA or TKA (Patient groups 3+4)
• Age ≥ 30 years (Healthy control group)

Exclusion criteria

• Body mass index > 35kg/m2
• Use of walking aids
• Neuromuscular disorders affecting gait
• Inability to follow procedures due to psychological disorders or dementia
• Diagnosed hip or knee OA (Healthy control group)
• Current pain in the lower extremities or lower back (Healthy control group)
• Rheumatoid Arthritis (Healthy control group)
• Previous corrective osteotomy (Healthy control group)
• Regular intake of pain medication (more than 4 times per week) (Healthy control group)

Trial design

130 participants in 5 patient groups

Patient group 1 after THA

Description:

Patients who have already received a THA (N=30) for OA will be assessed 1 year postoperatively (Visit A); Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'

Treatment:

Diagnostic Test: HOOS/ KOOS

Diagnostic Test: Passive range of motion

Diagnostic Test: Muscle strength test

Diagnostic Test: Dynamic stability test during level and uphill walking

Diagnostic Test: Postural stability test

Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L)

Diagnostic Test: Muscle activity test

Patient group 2 after TKA

Description:

Patients who have already received a TKA (N=30) for OA will be assessed 1 year postoperatively (Visit A); Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'

Treatment:

Diagnostic Test: HOOS/ KOOS

Diagnostic Test: Passive range of motion

Diagnostic Test: Muscle strength test

Diagnostic Test: Dynamic stability test during level and uphill walking

Diagnostic Test: Postural stability test

Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L)

Diagnostic Test: Muscle activity test

Patient group 3 before THA

Description:

Patients with severe hip OA (N=30) scheduled to receive a THA will be assessed preoperatively (Visit 1), 12 weeks postoperative (Visit 2) and 1 year postoperative (Visit 3). Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'

Treatment:

Diagnostic Test: HOOS/ KOOS

Diagnostic Test: Passive range of motion

Diagnostic Test: Muscle strength test

Diagnostic Test: Dynamic stability test during level and uphill walking

Diagnostic Test: Postural stability test

Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L)

Diagnostic Test: Muscle activity test

Patient group 4 before TKA

Description:

Patients with severe knee OA (N=30) scheduled to receive a TKA will be assessed preoperatively (Visit 1), 12 weeks postoperative (Visit 2) and 1 year postoperative (Visit 3). Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'

Treatment:

Diagnostic Test: HOOS/ KOOS

Diagnostic Test: Passive range of motion

Diagnostic Test: Muscle strength test

Diagnostic Test: Dynamic stability test during level and uphill walking

Diagnostic Test: Postural stability test

Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L)

Diagnostic Test: Muscle activity test

Healthy control group

Description:

Age-matched healthy control subjects (N=30);Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'

Treatment:

Diagnostic Test: HOOS/ KOOS

Diagnostic Test: Passive range of motion

Diagnostic Test: Muscle strength test

Diagnostic Test: Dynamic stability test during level and uphill walking

Diagnostic Test: Postural stability test

Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L)

Diagnostic Test: Muscle activity test