Clinical trial NCT03860610: TEPStabil - Muscle Function and Dynamic and Postural Stability in Patients Receiving Hip or Knee Arthroplasty
Official title: TEPStabil - Muscle Function and Dynamic and Postural Stability in Patients Receiving Hip or Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postural Stability
Keywords: Total Hip Arthroplasty
Total Knee Arthroplasty
Osteoarthritis
Muscle strength deficits
Dynamic stability
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 130
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited by consecutive recruitment through the contributing surgeons in daily clinical practice, referring physicians and advertisements placed bi-monthly in the University of Basel "Uni-news" and ongoing on the department website. Healthy participants will be recruited by advertisements placed bi-monthly in the University of Basel "Uni-news", local health and sports clubs and ongoing on the department website.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Muscle strength (Study 1)
timeFrame: single point measurement at Visit A (week 0)
measure: Change in Muscle strength (Study 2)
timeFrame: Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
measure: Postural stability (Study 1)
timeFrame: single point measurement at Visit A (week 0)
measure: Change in postural stability (Study 2)
timeFrame: Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
measure: Dynamic stability (Study 1)
timeFrame: single point measurement at Visit A (week 0)
measure: Change in dynamic stability (Study 2)
timeFrame: Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Annegret Muendermann, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: