Orthopaedic device and surgery studies combine patient-reported joint scores with clinician-rated ones. KOOS captures the knee from the patient's side; the Harris Hip Score is the classic clinician-rated hip score. Run both in one study.
Free sandbox · No credit card · 21 CFR Part 11 aligned
12-month score
86 / 100
At a glance
The instruments
Joint replacement, ligament reconstruction and cartilage repair studies are judged on whether patients can do more with less pain. Patient-reported scores like KOOS capture that directly, subscale by subscale, which matters because a treatment may improve daily activities without changing sport function. Clinician-rated scores like the Harris Hip Score add examination findings such as range of motion and deformity, and remain common in hip arthroplasty literature, which makes them useful for comparison with historical data.
KOOS subscales are scored separately rather than summed into one total, each transformed to 0 to 100. The Harris Hip Score combines interview and examination into a single total. Capture stores item responses as coded values and examination findings as numbers; scores are calculated in analysis according to the developers' scoring guides.
KOOS is for the knee. For hip studies the patient-reported counterpart is HOOS, with the same subscale structure. Many hip studies combine HOOS (patient) with the Harris Hip Score (clinician); knee studies often combine KOOS with a clinician-rated knee score.
Pain
78
ADL
82
Sport/Rec
45
Structure
| Instrument | Domain | Items or points | Completed by |
|---|---|---|---|
| KOOS | Pain | 9 items | Participant |
| KOOS | Symptoms | 7 items | Participant |
| KOOS | Activities of daily living | 17 items | Participant |
| KOOS | Sport and recreation | 5 items | Participant |
| KOOS | Knee-related quality of life | 4 items | Participant |
| Harris Hip Score | Pain | 44 points | Clinician |
| Harris Hip Score | Function (gait and activities) | 47 points | Clinician |
| Harris Hip Score | Absence of deformity | 4 points | Clinician |
| Harris Hip Score | Range of motion | 5 points | Clinician |
Structure only. Obtain the instruments and scoring guides from their developers and check their terms of use.
Long follow-up
Orthopaedic studies often run for years after surgery. Participant-reported scores can be completed at home on a phone, so a two-year follow-up does not need a clinic visit just for questionnaires, while clinician-rated scores are recorded at in-person visits.
EDC for medical device trials| Assessment | Pre-op | 6 wk | 3 mo | 6 mo | 1 yr | 2 yr |
|---|---|---|---|---|---|---|
| HOOS (ePRO) | ||||||
| Harris Hip Score | ||||||
| Radiographs | ||||||
| EQ-5D | ||||||
| Device AEs |
Patient scores at home, clinician scores at visits. Free sandbox.
Device studies
Orthopaedic implants are long-lived devices, and manufacturers collect outcome data for years after launch. Under the EU Medical Device Regulation, post-market clinical follow-up is part of keeping a device on the market, and patient-reported outcome measures such as KOOS and HOOS are a practical way to show continued performance. Registries and follow-up studies often collect them annually by questionnaire, with clinician scores and imaging at defined intervals.
Because follow-up is long and participants rarely need clinic visits, remote completion is what keeps response rates up. See post-market clinical studies for how Capture supports post-market data collection.
Before go-live
KOOS for knee, HOOS for hip, plus a clinician score.
For every instrument used.
Subscale scoring rules in the analysis plan.
Collected before surgery, not after.
Annual questionnaires with reminders.
Linked to the implant and procedure.
Five: pain, symptoms, activities of daily living, sport and recreation, and knee-related quality of life. Each is scored separately from 0 to 100, where 100 means no problems.
The original is completed by a clinician and includes a physical examination section. Modified versions without the examination are also used; record which version your study uses.
The Knee injury and Osteoarthritis Outcome Score, a 42-item patient-reported questionnaire with five subscales scored 0 to 100.
A clinician-completed hip score from 0 to 100 based on pain, function, absence of deformity and range of motion.
No, KOOS is for the knee. HOOS is the hip version with the same structure.
KOOS and HOOS are freely available from their developers. Check terms of use for each instrument you use.
Items and findings are stored as structured values; scores are calculated in analysis following the scoring guides.
Keep exploring
Patient and clinician scores in one study. Free sandbox.