Osteoarthritis (Knee / Hip)PRE-QoRNCT07879209
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
An observational study of Osteoarthritis (Knee / Hip) and Sarcopenia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In elderly patients undergoing arthroplasty surgery, postoperative recovery quality is closely related to preoperative physical reserve. Sarcopenia and reduced muscle quality can increase postoperative complications. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Osteoarthritis (Knee / Hip), Sarcopenia, Postoperative Recovery
- What is being tested?
- Handgrip Strength (HGS) Measurement and Ultrasound Shear Wave Elastography (SWE)
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Jul 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult surgical patients aged 60 years and older who are admitted to the hospital and scheduled for elective unilateral total knee or total hip arthroplasty under general or spinal anesthesia.
Who may be able to join
- Patients aged 60 years and older.
- Scheduled for elective unilateral total knee arthroplasty (TKA) or total hip arthroplasty (THA).
- American Society of Anesthesiologists (ASA) Physical Status classification I, II, or III.
- Six-Item Screener (SIS) score > 4 (indicating preserved baseline cognitive status).
- Voluntary participation with signed written informed consent.
Who cannot join
- History of upper extremity surgery, trauma, or pathology precluding handgrip or biceps brachii measurement.
- ASA Physical Status classification IV or V.
- Emergency surgical procedures.
- Significant baseline cognitive impairment (Six-Item Screener [SIS] score ≤ 4).
- Refusal to provide consent or withdrawal from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Preoperative Functional Reserve and Muscle Stiffness on Postoperative Quality of Recovery in Elective Lower Extremity Arthroplasty Surgeries
In elderly patients undergoing arthroplasty surgery, postoperative recovery quality is closely related to preoperative physical reserve. Sarcopenia and reduced muscle quality can increase postoperative complications. This prospective observational study aims to investigate whether preoperative Handgrip Strength (HGS) and muscle stiffness measured by Shear Wave Elastography (SWE) can predict the quality of recovery at postoperative 24 hours (assessed via the Quality of Recovery-15 [QoR-15T] score) in patients aged 60 and older undergoing elective total knee or hip arthroplasty.
Read the detailed description
Maintaining physiological homeostasis against surgical stress is a critical component of perioperative management. In this study, preoperative functional reserve will be assessed using Handgrip Strength (HGS) as a rapid, non-invasive marker of muscle strength and physical capacity. Quantitative muscle quality and stiffness (in kPa or m/s) will be evaluated via ultrasound Shear Wave Elastography (SWE) of the dominant biceps brachii muscle.
Patient-reported postoperative recovery quality will be measured using the validated Turkish version of the Quality of Recovery-15 score (QoR-15T). Secondary objectives include assessing the correlation between HGS and SWE measurements, evaluating the influence of anesthesia type (general vs. spinal anesthesia) on QoR-15T scores in patients with low functional reserve, and analyzing the association of baseline routine laboratory parameters (e.g., albumin, total protein, CRP, calcium and creatinine) with recovery outcomes. All procedures are observational, non-invasive, and integrated into standard perioperative care without altering routine clinical management.
- Being tested
- Handgrip Strength (HGS) Measurement, Ultrasound Shear Wave Elastography (SWE)
- Keywords
- Handgrip strength, Shear Wave Elastography, QoR-15, Quality of Recovery, Arthroplasty, Geriatric anesthesia, Functional reserve, Arthroplasty, Replacement; Anesthesia
- Medical subject headings
- Osteoarthritis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip Strength (HGS) MeasurementDiagnostic test
Isometric handgrip strength measured preoperatively using a hydraulic hand dynamometer on the dominant hand (mean of 3 consecutive measurements in kg).
Ultrasound Shear Wave Elastography (SWE)Diagnostic test
Quantitative measurement of biceps brachii muscle stiffness (shear wave elasticity kPa) assessed preoperatively at rest and during contraction using ultrasound shear wave elastography.
| Study group | Role | What they receive |
|---|---|---|
| Elective Arthroplasty Patients | Patients aged 60 years and older undergoing elective unilateral total knee arthroplasty (TKA) or total hip arthroplasty (THA) under general or spinal anesthesia. Receives: Diagnostic Test: Handgrip Strength (HGS) Measurement; Diagnostic Test: Ultrasound Shear Wave Elastography (SWE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Quality of Recovery Score (QoR-15T)
Postoperative quality of recovery assessed at the bedside using the validated Turkish version of the Quality of Recovery-15 (QoR-15T) scale. The scale evaluates five dimensions: pain, physical comfort, emotional state, physical independence, and psychological support. Total scores range from 0 to 150, where higher scores represent superior recovery quality.
Measured: Postoperative 24 hours
Secondary outcomes (4)
Dominant Handgrip Strength (HGS)
Maximum isometric handgrip strength (measured in kilograms) evaluated using a Baseline LITE hydraulic hand dynamometer on the dominant hand. The mean value of three consecutive attempts will be recorded.
Measured: Preoperative baseline (Day of surgery, prior to induction)
Biceps Brachii Muscle Stiffness Measured by Shear Wave Elastography (SWE)
Quantitative measurement of dominant biceps brachii muscle stiffness (shear wave elasticity in kPa) evaluated using ultrasound shear wave elastography. Three consecutive measurements each will be obtained during muscle relaxation and active contraction, and averaged.
Measured: Preoperative baseline (Day of surgery, prior to induction)
Comparison of Postoperative QoR-15T Scores by Anesthesia Technique
Comparison of 24-hour postoperative QoR-15T scores between patients receiving general anesthesia versus spinal anesthesia, specifically analyzing the interaction with preoperative functional reserve levels.
Measured: Postoperative 24 hours
Correlation Between Routine Preoperative Laboratory Biomarkers and Recovery Scores
Assessment of the correlation between baseline routine laboratory parameters (C-reactive protein, serum albumin, total protein, creatinine, calcium) and 24-hour postoperative QoR-15T recovery scores.
Measured: Preoperative baseline (up to 7 days prior to surgery) and postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (Knee / Hip)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Derya Ozkan, Prof. MD, Principal investigator, Ankara Etlik City Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879209
- Sponsor's protocol ID
- AEŞH-EK-2026-104
- Acronym
- PRE-QoR
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the study will not be shared beyond the research group to protect participant confidentiality in accordance with the study protocol and ethics committee approval.